Smoking CessationPhase 4NCINCT01342523

Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources

A Phase 4 study testing CIS - telephone cessation quitline counseling, Lozenge - nicotine mini-lozenges and Emails - Brief smoking prevention messages in people with Smoking Cessation and Smoking, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking Cessation, Smoking, Nicotine Dependence
What is being tested?: CIS - telephone cessation quitline counseling, Lozenge - nicotine mini-lozenges and Emails - Brief smoking prevention messages
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,034 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Oct 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(1). Interest in quitting smoking within the next 30 days, but not already actively engaged in quitting (e.g., subject should not be currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). The person has a phone and has home internet access; (3). The person has an email address that can be used to send assessments, and deliver email prompts; (4). The person expresses willingness to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes ≥ 5 cpd; (7). The person is ≥ 18 years;(8). The person accesses the internet with no more than 3 computers/devices (including devices such as iPads and smartphones); and (9). No other members of the person's household are participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.) Subjects will not have to express an interest in using NRT. They may be sent NRT depending upon experimental assignment, but a commitment to use medication is not a requirement of participation. Also, pregnant smokers, or those who believe they may become pregnant, can participate, but they will be randomly assigned to only the non-medication treatments and participate only in the substudy. [They will not be included in the regular data analyses, and power will be too small to permit meaningful inferential tests. However, effect sizes in this small group of smokers will be determined for comparison with the effect sizes obtained in the main study.] Due to limitations in the volume of new calls that can be handled in the phone counseling component, recruitment will not exceed 300 per month. When monthly recruitment goal has been met, the recruitment invitation will be turned off until the following month. At the point where it is necessary to achieve the desired (50/50) gender balance, the invitation to participate in the study will be restricted by sex until full enrollment is achieved.

Who cannot join

(1). If the person has no interest in quitting smoking within the next 30 days or if the person is actively engaged in quitting (e.g., subject is currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). Person does not have a phone or home internet access; (3). The person does not have an email address that can be used to send assessments, and deliver email prompts; (4). The person is not willing to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes < 5 cpd; (7). The person is <18 years;(8). The person accesses the internet with more than 4 computers (including devices such as iPads and smartphones); and (9). One or more members of the person's household are already participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711

Other trials in United States

About this study

Official title: Evaluation of NCI Smoking Intervention Resources

This is an evaluative study of three National Cancer Institute (NCI) smoking cessation resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS counseling phone calls. The following are the identified critical questions: (1). How effective is each of the tobacco interventions (websites [smokefree.gov \& women smokefree.gov], NCI's Cessation Quitline counseling services operated by the Cancer Information Service (CIS) (2). How do they compare with alternative intervention strategies? (3). Which types of interventions appear to work best together (due to additive or interactive effects)? (4). How do these interventions work? (5). How much are these interventions used, and what are their relative use rates? (6). Are there important differences in effectiveness or use rates as a function of gender, SES, or other important person factors? We believe that the research study will address all of these questions, as well as some less central ones.

Read the detailed description

This an evaluative study of three National Cancer Institute (NCI) smoking cessation resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS counseling phone calls. The following are the identified critical questions: (1). How effective is each of the tobacco interventions (websites [smokefree.gov \& women smokefree.gov], NCI's Cessation Quitline counseling services operated by the Cancer Information Service (CIS) (2). How do they compare with alternative intervention strategies? (3). Which types of interventions appear to work best together (due to additive or interactive effects)? (4). How do these interventions work? (5). How much are these interventions used, and what are their relative use rates? (6). Are there important differences in effectiveness or use rates as a function of gender, SES, or other important person factors? We believe that the research study will address all of these questions, as well as some less central ones.

The primary goal of this research is to obtain experimental data on the effectiveness of the major eHealth and communication smoking cessation interventions (smokefree.gov, women smokefree.gov, and NCI's Quitline counseling services). The primary bases for comparison would be quit attempts and cessation success, and each intervention would be compared with a control condition not receiving the intervention. In addition to the targeted interventions, participants may also be assigned to several different comparison interventions: i.e., email prompts, mailings/brochures, and OTC nicotine medication. The resulting data would allow us to determine effect sizes for each type of intervention relative to a control condition, which would allow us to determine the relative effectiveness of each intervention: i.e., how well the interventions stack-up against one another in terms of effect sizes.

Secondary goals of this research are to:

. Determine how much the participants use the interventions;
. Determine the mechanisms of benefit (perform meditational analyses);
. Compare benefits for important smoker populations;
. Determine whether any of the interventions produce subtractive or synergistic effects; and
. Obtain basic health economic estimates such as cost/quitter.

The project will also include a substudy directed toward pregnant women and women who are interested in participating but are unwilling to agree to utilize approved contraceptive methods for the duration of the study. This substudy will utilize all of the treatment conditions except the medication condition, since medication is not recommended for women who are pregnant in the US. Department of Health and Human Services treatment guideline for tobacco dependence

Conditions: Smoking Cessation, Smoking, Nicotine Dependence
Being tested: CIS - telephone cessation quitline counseling, Lozenge - nicotine mini-lozenges, Emails - Brief smoking prevention messages, Full website - standard smokefree.gov website content, Lite website - lite version of smokefree.gov
Keywords: Smoking Cessation, Smoking, Nicotine
Medical subject headings: Smoking Cessation, Smoking, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CIS - telephone cessation quitline counselingOther
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozengesOther
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messagesOther
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website contentOther
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Lite website - lite version of smokefree.govOther
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guideOther
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
brief mailed booklet - smaller version of NCI's bookletOther
12-page booklet developed by the investigators for the research (considered to be placebo intervention)

Study groups in NCT01342523
Study group	Role	What they receive
No CIS/No loz/No Email/Lite Website/Brief Booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, No nicotine lozenge, No motivational emails, lite website, brief mailed booklet Receives: Other: Lite website - lite version of smokefree.gov; Other: brief mailed booklet - smaller version of NCI's booklet
CIS/No loz/No email/Lite Website/Brief booklet	Experimental	This arm of the project will address the following question: Does the following treatment provide efficacy relative to others: CIS calls, no NRT lozenge, no motivational email, Lite website, Brief mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lite website - lite version of smokefree.gov; Other: brief mailed booklet - smaller version of NCI's booklet
no CIS/Loz/No email/lite website/brief booklet	Experimental	This arm of the project will address the following question: Does this combination of services achieve effectiveness compared to others: No CIS phone counseling, NRT lozenge, no motivational email, lite website, brief mailed booklet Receives: Other: Lozenge - nicotine mini-lozenges; Other: Lite website - lite version of smokefree.gov; Other: brief mailed booklet - smaller version of NCI's booklet
No CIS/no loz/email/lite website/brief booklet	Experimental	This arm of the project will address the following question: Does this combination of services lead to greater abstinence: No CIS counseling calls, no NRT lozenge, motivational emails, lite website, brief mailed booklet. Receives: Other: Emails - Brief smoking prevention messages; Other: Lite website - lite version of smokefree.gov; Other: brief mailed booklet - smaller version of NCI's booklet
No CIS/No loz/No email/Full website/Brief booklet	Experimental	This arm of the project will address the following question: Does this combination of services lead to greater abstinence? No CIS counseling, no NRT lozenge, no motivational email, full website, brief mailed booklet Receives: Other: Full website - standard smokefree.gov website content; Other: brief mailed booklet - smaller version of NCI's booklet
No CIS/No loz/No email/lite website/full booklet	Experimental	This arm seeks to answer the question: Does this combination of services achieve efficacy compared to others: No CIS counseling, no NRT lozenge, no motivational email, lite website, full mailed booklet Receives: Other: Lite website - lite version of smokefree.gov; Other: Full mailed booklet - NCI's detailed 36-page quit guide
CIS/Loz/No email/Lite website/Brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, lite website, brief mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lozenge - nicotine mini-lozenges; Other: Lite website - lite version of smokefree.gov; Other: brief mailed booklet - smaller version of NCI's booklet
CIS/No loz/Emails/Lite Website/Brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, motivational emails, lite website, brief mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Emails - Brief smoking prevention messages; Other: Lite website - lite version of smokefree.gov; Other: brief mailed booklet - smaller version of NCI's booklet
CIS/No loz/no email/full website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, No motivational emails, full website, brief mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Full website - standard smokefree.gov website content; Other: brief mailed booklet - smaller version of NCI's booklet
CIS/No loz/no email/lite website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, No motivational emails, lite website, full mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lite website - lite version of smokefree.gov; Other: Full mailed booklet - NCI's detailed 36-page quit guide
No CIS/Loz/emails/Lite Website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, lite website, brief mailed booklet Receives: Other: Lozenge - nicotine mini-lozenges; Other: Emails - Brief smoking prevention messages; Other: Lite website - lite version of smokefree.gov; Other: brief mailed booklet - smaller version of NCI's booklet
No CIS/Loz/No emails/lite website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, lite website, full mailed booklet Receives: Other: Lozenge - nicotine mini-lozenges; Other: Lite website - lite version of smokefree.gov; Other: Full mailed booklet - NCI's detailed 36-page quit guide
No CIS/Loz/No emails/full website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, full website, brief mailed booklet Receives: Other: Lozenge - nicotine mini-lozenges; Other: Full website - standard smokefree.gov website content; Other: brief mailed booklet - smaller version of NCI's booklet
no CIS/no loz/emails/full website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, full website, brief mailed booklet Receives: Other: Emails - Brief smoking prevention messages; Other: Full website - standard smokefree.gov website content; Other: brief mailed booklet - smaller version of NCI's booklet
no CIS/no loz/emails/lite web/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, lite website, full mailed booklet Receives: Other: Emails - Brief smoking prevention messages; Other: Lite website - lite version of smokefree.gov; Other: Full mailed booklet - NCI's detailed 36-page quit guide
no CIS/no loz/no email/full website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, No motivational emails, full website, full mailed booklet Receives: Other: Full website - standard smokefree.gov website content; Other: Full mailed booklet - NCI's detailed 36-page quit guide
CIS/loz/emails/lite website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, lite website, brief mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lozenge - nicotine mini-lozenges; Other: Emails - Brief smoking prevention messages; Other: Lite website - lite version of smokefree.gov; Other: brief mailed booklet - smaller version of NCI's booklet
CIS/loz/no email/full website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, full website, brief mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lozenge - nicotine mini-lozenges; Other: Full website - standard smokefree.gov website content; Other: brief mailed booklet - smaller version of NCI's booklet
CIS/loz/no email/lite website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, lite website, full mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lozenge - nicotine mini-lozenges; Other: Lite website - lite version of smokefree.gov; Other: Full mailed booklet - NCI's detailed 36-page quit guide
CIS/no loz/emails/full website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, full website, brief mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Emails - Brief smoking prevention messages; Other: Full website - standard smokefree.gov website content; Other: brief mailed booklet - smaller version of NCI's booklet
CIS/no loz/emails/lite website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, lite website, full mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Emails - Brief smoking prevention messages; Other: Lite website - lite version of smokefree.gov; Other: Full mailed booklet - NCI's detailed 36-page quit guide
CIS/no loz/no email/full website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, No motivational emails, full website, full mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Full website - standard smokefree.gov website content; Other: Full mailed booklet - NCI's detailed 36-page quit guide
No CIS/loz/emails/full website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, full website, brief mailed booklet Receives: Other: Lozenge - nicotine mini-lozenges; Other: Emails - Brief smoking prevention messages; Other: Full website - standard smokefree.gov website content; Other: brief mailed booklet - smaller version of NCI's booklet
No CIS/loz/emails/lite website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, lite website, full mailed booklet Receives: Other: Lozenge - nicotine mini-lozenges; Other: Emails - Brief smoking prevention messages; Other: Lite website - lite version of smokefree.gov; Other: Full mailed booklet - NCI's detailed 36-page quit guide
No CIS/loz/no emails/full website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, full website, full mailed booklet Receives: Other: Lozenge - nicotine mini-lozenges; Other: Full website - standard smokefree.gov website content; Other: Full mailed booklet - NCI's detailed 36-page quit guide
no CIS/no loz/emails/full website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, full website, full mailed booklet Receives: Other: Emails - Brief smoking prevention messages; Other: Full website - standard smokefree.gov website content; Other: Full mailed booklet - NCI's detailed 36-page quit guide
CIS/loz/emails/full website/brief booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, full website, brief mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lozenge - nicotine mini-lozenges; Other: Emails - Brief smoking prevention messages; Other: Full website - standard smokefree.gov website content; Other: brief mailed booklet - smaller version of NCI's booklet
CIS/loz/emails/lite website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, lite website, full mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lozenge - nicotine mini-lozenges; Other: Emails - Brief smoking prevention messages; Other: Lite website - lite version of smokefree.gov; Other: Full mailed booklet - NCI's detailed 36-page quit guide
No CIS/loz/emails/full website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, full website, full mailed booklet Receives: Other: Lozenge - nicotine mini-lozenges; Other: Emails - Brief smoking prevention messages; Other: Full website - standard smokefree.gov website content; Other: Full mailed booklet - NCI's detailed 36-page quit guide
CIS/no loz/emails/full website/full booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, full website, full mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Emails - Brief smoking prevention messages; Other: Full website - standard smokefree.gov website content; Other: Full mailed booklet - NCI's detailed 36-page quit guide
CIS/Loz/no Emails/Full Website/Full Booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, full website, full mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lozenge - nicotine mini-lozenges; Other: Full website - standard smokefree.gov website content; Other: Full mailed booklet - NCI's detailed 36-page quit guide
CIS/Loz/Emails/Full Website/Full Booklet	Experimental	This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, full website, full mailed booklet Receives: Other: CIS - telephone cessation quitline counseling; Other: Lozenge - nicotine mini-lozenges; Other: Emails - Brief smoking prevention messages; Other: Full website - standard smokefree.gov website content; Other: Full mailed booklet - NCI's detailed 36-page quit guide

What is being measured

The primary outcome is the main question the study is designed to answer.

7-Day Point-Prevalence Abstinence From Smoking
Abstinence will be defined as 7-day point prevalence.
Measured: Measured after the 3 month follow up assessment

Secondary outcomes (7)

Smoking Outcomes
Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.
Measured: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.
Resource Use/Engagement
We will measure participants' use the experimental resources compared to the non-experimental resources. Particularly with the study websites, we will be tracking how often and how long participants use the regular smokefree.gov website versus the placebo website as well as what parts of the websites they are using for 6 months.
Measured: Assessed at the 7 month follow up assessment. Furthermore, Website use will be collected as pages viewed, time viewed, use occasions, and composite measures. Counseling use will be measured by number of counseling calls.
Effectiveness of the Experimental Resources.
We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.
Measured: Data collected at all assessments (Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). Analyzed after the study.
Withdrawal Symptoms
We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.
Measured: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.
Perceived Support
We will measure perceived support from both treatment and non-treatment resources.
Measured: Measured at the1 month, 3 month and 7 month follow up assessments.
Treatment Satisfaction
We will measure how satisfied participants were with the resources they were given as well as what might have made their quit attempts easier or more successful.
Measured: Measured at the 1 month, 3 month and 7 month follow up assessments
Increased Quit Attempts
Quit attempts will be defined in two ways: self-report of a serious attempt to quit, and occurrence of at least a 24 hr period of abstinence that was for the purpose of cessation.
Measured: Measured at the 1 month, 3 month and 7 month follow up assessments.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Oct 2013

First posted27 Apr 2011 (estimated)
Study startOct 2011
Primary completionMay 2012
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Smoking CessationStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 1,034 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01342523
Sponsor's protocol ID: 2011-0007
Acronym: NCI
Status last verified: Oct 2015
First submitted: 8 Mar 2011
Last updated: 14 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of NCI Smoking Intervention Resources
ClinicalTrials.gov ID: NCT01342523
Acronym / sponsor ID: NCI / 2011-0007
Conditions: Smoking Cessation, Smoking, Nicotine Dependence
Keywords: Smoking Cessation, Smoking, Nicotine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,034 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Fred Hutchinson Cancer Center
Study start: Oct 2011
Primary completion: May 2012 (actual)
Study completion: Oct 2013 (actual)
First posted: 27 Apr 2011 (estimated)
Results: Posted 5 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Secondary goals of this research are to:

. Determine how much the participants use the interventions;
. Determine the mechanisms of benefit (perform meditational analyses);
. Compare benefits for important smoker populations;
. Determine whether any of the interventions produce subtractive or synergistic effects; and
. Obtain basic health economic estimates such as cost/quitter.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 32

Arm	Type	Receives
No CIS/No loz/No Email/Lite Website/Brief Booklet	Experimental	Other: Lite website - lite version of smokefree.gov, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, No nicotine lozenge, No motivational emails, lite website, brief mailed booklet
CIS/No loz/No email/Lite Website/Brief booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lite website - lite version of smokefree.gov, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: Does the following treatment provide efficacy relative to others: CIS calls, no NRT lozenge, no motivational email, Lite website, Brief mailed booklet
no CIS/Loz/No email/lite website/brief booklet	Experimental	Other: Lozenge - nicotine mini-lozenges, Other: Lite website - lite version of smokefree.gov, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: Does this combination of services achieve effectiveness compared to others: No CIS phone counseling, NRT lozenge, no motivational email, lite website, brief mailed booklet
No CIS/no loz/email/lite website/brief booklet	Experimental	Other: Emails - Brief smoking prevention messages, Other: Lite website - lite version of smokefree.gov, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: Does this combination of services lead to greater abstinence: No CIS counseling calls, no NRT lozenge, motivational emails, lite website, brief mailed booklet.
No CIS/No loz/No email/Full website/Brief booklet	Experimental	Other: Full website - standard smokefree.gov website content, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: Does this combination of services lead to greater abstinence? No CIS counseling, no NRT lozenge, no motivational email, full website, brief mailed booklet
No CIS/No loz/No email/lite website/full booklet	Experimental	Other: Lite website - lite version of smokefree.gov, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm seeks to answer the question: Does this combination of services achieve efficacy compared to others: No CIS counseling, no NRT lozenge, no motivational email, lite website, full mailed booklet
CIS/Loz/No email/Lite website/Brief booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lozenge - nicotine mini-lozenges, Other: Lite website - lite version of smokefree.gov, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, lite website, brief mailed booklet
CIS/No loz/Emails/Lite Website/Brief booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Emails - Brief smoking prevention messages, Other: Lite website - lite version of smokefree.gov, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, motivational emails, lite website, brief mailed booklet
CIS/No loz/no email/full website/brief booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Full website - standard smokefree.gov website content, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, No motivational emails, full website, brief mailed booklet
CIS/No loz/no email/lite website/full booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lite website - lite version of smokefree.gov, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, No motivational emails, lite website, full mailed booklet
No CIS/Loz/emails/Lite Website/brief booklet	Experimental	Other: Lozenge - nicotine mini-lozenges, Other: Emails - Brief smoking prevention messages, Other: Lite website - lite version of smokefree.gov, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, lite website, brief mailed booklet
No CIS/Loz/No emails/lite website/full booklet	Experimental	Other: Lozenge - nicotine mini-lozenges, Other: Lite website - lite version of smokefree.gov, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, lite website, full mailed booklet
No CIS/Loz/No emails/full website/brief booklet	Experimental	Other: Lozenge - nicotine mini-lozenges, Other: Full website - standard smokefree.gov website content, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, full website, brief mailed booklet
no CIS/no loz/emails/full website/brief booklet	Experimental	Other: Emails - Brief smoking prevention messages, Other: Full website - standard smokefree.gov website content, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, full website, brief mailed booklet
no CIS/no loz/emails/lite web/full booklet	Experimental	Other: Emails - Brief smoking prevention messages, Other: Lite website - lite version of smokefree.gov, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, lite website, full mailed booklet
no CIS/no loz/no email/full website/full booklet	Experimental	Other: Full website - standard smokefree.gov website content, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, No motivational emails, full website, full mailed booklet
CIS/loz/emails/lite website/brief booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lozenge - nicotine mini-lozenges, Other: Emails - Brief smoking prevention messages, Other: Lite website - lite version of smokefree.gov, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, lite website, brief mailed booklet
CIS/loz/no email/full website/brief booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lozenge - nicotine mini-lozenges, Other: Full website - standard smokefree.gov website content, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, full website, brief mailed booklet
CIS/loz/no email/lite website/full booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lozenge - nicotine mini-lozenges, Other: Lite website - lite version of smokefree.gov, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, lite website, full mailed booklet
CIS/no loz/emails/full website/brief booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Emails - Brief smoking prevention messages, Other: Full website - standard smokefree.gov website content, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, full website, brief mailed booklet
CIS/no loz/emails/lite website/full booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Emails - Brief smoking prevention messages, Other: Lite website - lite version of smokefree.gov, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, lite website, full mailed booklet
CIS/no loz/no email/full website/full booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Full website - standard smokefree.gov website content, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, No motivational emails, full website, full mailed booklet
No CIS/loz/emails/full website/brief booklet	Experimental	Other: Lozenge - nicotine mini-lozenges, Other: Emails - Brief smoking prevention messages, Other: Full website - standard smokefree.gov website content, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, full website, brief mailed booklet
No CIS/loz/emails/lite website/full booklet	Experimental	Other: Lozenge - nicotine mini-lozenges, Other: Emails - Brief smoking prevention messages, Other: Lite website - lite version of smokefree.gov, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, lite website, full mailed booklet
No CIS/loz/no emails/full website/full booklet	Experimental	Other: Lozenge - nicotine mini-lozenges, Other: Full website - standard smokefree.gov website content, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, full website, full mailed booklet
no CIS/no loz/emails/full website/full booklet	Experimental	Other: Emails - Brief smoking prevention messages, Other: Full website - standard smokefree.gov website content, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, full website, full mailed booklet
CIS/loz/emails/full website/brief booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lozenge - nicotine mini-lozenges, Other: Emails - Brief smoking prevention messages, Other: Full website - standard smokefree.gov website content, Other: brief mailed booklet - smaller version of NCI's bookletThis arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, full website, brief mailed booklet
CIS/loz/emails/lite website/full booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lozenge - nicotine mini-lozenges, Other: Emails - Brief smoking prevention messages, Other: Lite website - lite version of smokefree.gov, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, lite website, full mailed booklet
No CIS/loz/emails/full website/full booklet	Experimental	Other: Lozenge - nicotine mini-lozenges, Other: Emails - Brief smoking prevention messages, Other: Full website - standard smokefree.gov website content, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, full website, full mailed booklet
CIS/no loz/emails/full website/full booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Emails - Brief smoking prevention messages, Other: Full website - standard smokefree.gov website content, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, full website, full mailed booklet
CIS/Loz/no Emails/Full Website/Full Booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lozenge - nicotine mini-lozenges, Other: Full website - standard smokefree.gov website content, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, full website, full mailed booklet
CIS/Loz/Emails/Full Website/Full Booklet	Experimental	Other: CIS - telephone cessation quitline counseling, Other: Lozenge - nicotine mini-lozenges, Other: Emails - Brief smoking prevention messages, Other: Full website - standard smokefree.gov website content, Other: Full mailed booklet - NCI's detailed 36-page quit guideThis arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, full website, full mailed booklet

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

(1). Interest in quitting smoking within the next 30 days, but not already actively engaged in quitting (e.g., subject should not be currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). The person has a phone and has home internet access; (3). The person has an email address that can be used to send assessments, and deliver email prompts; (4). The person expresses willingness to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes ≥ 5 cpd; (7). The person is ≥ 18 years;(8). The person accesses the internet with no more than 3 computers/devices (including devices such as iPads and smartphones); and (9). No other members of the person's household are participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.) Subjects will not have to express an interest in using NRT. They may be sent NRT depending upon experimental assignment, but a commitment to use medication is not a requirement of participation. Also, pregnant smokers, or those who believe they may become pregnant, can participate, but they will be randomly assigned to only the non-medication treatments and participate only in the substudy. [They will not be included in the regular data analyses, and power will be too small to permit meaningful inferential tests. However, effect sizes in this small group of smokers will be determined for comparison with the effect sizes obtained in the main study.] Due to limitations in the volume of new calls that can be handled in the phone counseling component, recruitment will not exceed 300 per month. When monthly recruitment goal has been met, the recruitment invitation will be turned off until the following month. At the point where it is necessary to achieve the desired (50/50) gender balance, the invitation to participate in the study will be restricted by sex until full enrollment is achieved.

Key exclusion criteria (1 listed)

(1). If the person has no interest in quitting smoking within the next 30 days or if the person is actively engaged in quitting (e.g., subject is currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). Person does not have a phone or home internet access; (3). The person does not have an email address that can be used to send assessments, and deliver email prompts; (4). The person is not willing to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes < 5 cpd; (7). The person is <18 years;(8). The person accesses the internet with more than 4 computers (including devices such as iPads and smartphones); and (9). One or more members of the person's household are already participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CIS - telephone cessation quitline counselingUp to 5 total tobacco cessation counseling calls	Other	CIS/Loz/Emails/Full Website/Full Booklet, CIS/Loz/No email/Lite website/Brief booklet, CIS/Loz/no Emails/Full Website/Full Booklet, CIS/No loz/Emails/Lite Website/Brief booklet, CIS/No loz/No email/Lite Website/Brief booklet, CIS/No loz/no email/full website/brief booklet, CIS/No loz/no email/lite website/full booklet, CIS/loz/emails/full website/brief booklet, CIS/loz/emails/lite website/brief booklet, CIS/loz/emails/lite website/full booklet, CIS/loz/no email/full website/brief booklet, CIS/loz/no email/lite website/full booklet, CIS/no loz/emails/full website/brief booklet, CIS/no loz/emails/full website/full booklet, CIS/no loz/emails/lite website/full booklet, CIS/no loz/no email/full website/full booklet
Lozenge - nicotine mini-lozenges2-week starter pack of nicotine mini-lozenges	Other	CIS/Loz/Emails/Full Website/Full Booklet, CIS/Loz/No email/Lite website/Brief booklet, CIS/Loz/no Emails/Full Website/Full Booklet, CIS/loz/emails/full website/brief booklet, CIS/loz/emails/lite website/brief booklet, CIS/loz/emails/lite website/full booklet, CIS/loz/no email/full website/brief booklet, CIS/loz/no email/lite website/full booklet, No CIS/Loz/No emails/full website/brief booklet, No CIS/Loz/No emails/lite website/full booklet, No CIS/Loz/emails/Lite Website/brief booklet, No CIS/loz/emails/full website/brief booklet, No CIS/loz/emails/full website/full booklet, No CIS/loz/emails/lite website/full booklet, No CIS/loz/no emails/full website/full booklet, no CIS/Loz/No email/lite website/brief booklet
Emails - Brief smoking prevention messagesBrief email messages that could be accessed by any computer or mobile device that allowed email receipt	Other	CIS/Loz/Emails/Full Website/Full Booklet, CIS/No loz/Emails/Lite Website/Brief booklet, CIS/loz/emails/full website/brief booklet, CIS/loz/emails/lite website/brief booklet, CIS/loz/emails/lite website/full booklet, CIS/no loz/emails/full website/brief booklet, CIS/no loz/emails/full website/full booklet, CIS/no loz/emails/lite website/full booklet, No CIS/Loz/emails/Lite Website/brief booklet, No CIS/loz/emails/full website/brief booklet, No CIS/loz/emails/full website/full booklet, No CIS/loz/emails/lite website/full booklet, No CIS/no loz/email/lite website/brief booklet, no CIS/no loz/emails/full website/brief booklet, no CIS/no loz/emails/full website/full booklet, no CIS/no loz/emails/lite web/full booklet
Full website - standard smokefree.gov website contentOver 50 web pages of resources for quitting smoking, including interactive features and referral links	Other	CIS/Loz/Emails/Full Website/Full Booklet, CIS/Loz/no Emails/Full Website/Full Booklet, CIS/No loz/no email/full website/brief booklet, CIS/loz/emails/full website/brief booklet, CIS/loz/no email/full website/brief booklet, CIS/no loz/emails/full website/brief booklet, CIS/no loz/emails/full website/full booklet, CIS/no loz/no email/full website/full booklet, No CIS/Loz/No emails/full website/brief booklet, No CIS/No loz/No email/Full website/Brief booklet, No CIS/loz/emails/full website/brief booklet, No CIS/loz/emails/full website/full booklet, No CIS/loz/no emails/full website/full booklet, no CIS/no loz/emails/full website/brief booklet, no CIS/no loz/emails/full website/full booklet, no CIS/no loz/no email/full website/full booklet
Lite website - lite version of smokefree.govReduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)	Other	CIS/Loz/No email/Lite website/Brief booklet, CIS/No loz/Emails/Lite Website/Brief booklet, CIS/No loz/No email/Lite Website/Brief booklet, CIS/No loz/no email/lite website/full booklet, CIS/loz/emails/lite website/brief booklet, CIS/loz/emails/lite website/full booklet, CIS/loz/no email/lite website/full booklet, CIS/no loz/emails/lite website/full booklet, No CIS/Loz/No emails/lite website/full booklet, No CIS/Loz/emails/Lite Website/brief booklet, No CIS/No loz/No Email/Lite Website/Brief Booklet, No CIS/No loz/No email/lite website/full booklet, No CIS/loz/emails/lite website/full booklet, No CIS/no loz/email/lite website/brief booklet, no CIS/Loz/No email/lite website/brief booklet, no CIS/no loz/emails/lite web/full booklet
Full mailed booklet - NCI's detailed 36-page quit guideNCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse	Other	CIS/Loz/Emails/Full Website/Full Booklet, CIS/Loz/no Emails/Full Website/Full Booklet, CIS/No loz/no email/lite website/full booklet, CIS/loz/emails/lite website/full booklet, CIS/loz/no email/lite website/full booklet, CIS/no loz/emails/full website/full booklet, CIS/no loz/emails/lite website/full booklet, CIS/no loz/no email/full website/full booklet, No CIS/Loz/No emails/lite website/full booklet, No CIS/No loz/No email/lite website/full booklet, No CIS/loz/emails/full website/full booklet, No CIS/loz/emails/lite website/full booklet, No CIS/loz/no emails/full website/full booklet, no CIS/no loz/emails/full website/full booklet, no CIS/no loz/emails/lite web/full booklet, no CIS/no loz/no email/full website/full booklet
brief mailed booklet - smaller version of NCI's booklet12-page booklet developed by the investigators for the research (considered to be placebo intervention)	Other	CIS/Loz/No email/Lite website/Brief booklet, CIS/No loz/Emails/Lite Website/Brief booklet, CIS/No loz/No email/Lite Website/Brief booklet, CIS/No loz/no email/full website/brief booklet, CIS/loz/emails/full website/brief booklet, CIS/loz/emails/lite website/brief booklet, CIS/loz/no email/full website/brief booklet, CIS/no loz/emails/full website/brief booklet, No CIS/Loz/No emails/full website/brief booklet, No CIS/Loz/emails/Lite Website/brief booklet, No CIS/No loz/No Email/Lite Website/Brief Booklet, No CIS/No loz/No email/Full website/Brief booklet, No CIS/loz/emails/full website/brief booklet, No CIS/no loz/email/lite website/brief booklet, no CIS/Loz/No email/lite website/brief booklet, no CIS/no loz/emails/full website/brief booklet

Primary outcome

7-Day Point-Prevalence Abstinence From Smoking
Time frame: Measured after the 3 month follow up assessment
Abstinence will be defined as 7-day point prevalence.

7 secondary outcomes

Smoking Outcomes
Time frame: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.
Resource Use/Engagement
Time frame: Assessed at the 7 month follow up assessment. Furthermore, Website use will be collected as pages viewed, time viewed, use occasions, and composite measures. Counseling use will be measured by number of counseling calls.
Effectiveness of the Experimental Resources.
Time frame: Data collected at all assessments (Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). Analyzed after the study.
Withdrawal Symptoms
Time frame: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.
Perceived Support
Time frame: Measured at the1 month, 3 month and 7 month follow up assessments.
Treatment Satisfaction
Time frame: Measured at the 1 month, 3 month and 7 month follow up assessments
Increased Quit Attempts
Time frame: Measured at the 1 month, 3 month and 7 month follow up assessments.

Results and safety

Results posted to the registry on 5 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No CIS/No Loz/No Email/Lite Website/Brief Booklet	35	34
CIS/No Loz/No Email/Lite Website/Brief Booklet	32	32
no CIS/Loz/No Email/Lite Website/Brief Booklet	36	36
No CIS/no Loz/Email/Lite Website/Brief Booklet	33	32
No CIS/No Loz/No Email/Full Website/Brief Booklet	36	36
No CIS/No Loz/No Email/Lite Website/Full Booklet	36	36
CIS/Loz/No Email/Lite Website/Brief Booklet	22	22
CIS/No Loz/Emails/Lite Website/Brief Booklet	27	27
CIS/No Loz/no Email/Full Website/Brief Booklet	28	28
CIS/No Loz/no Email/Lite Website/Full Booklet	28	28
No CIS/Loz/Emails/Lite Website/Brief Booklet	38	38
No CIS/Loz/No Emails/Lite Website/Full Booklet	38	36
No CIS/Loz/No Emails/Full Website/Lite Booklet	39	39
no CIS/no Loz/Emails/Full Website/Brief Booklet	38	36
no CIS/no Loz/Emails/Lite Web/Full Booklet	38	37
no CIS/no Loz/no Email/Full Website/Full Booklet	32	32
CIS/Loz/Emails/Lite Website/Brief Booklet	29	28
CIS/Loz/no Email/Full Website/Brief Booklet	27	27
CIS/Loz/no Email/Lite Website/Full Booklet	21	21
CIS/no Loz/Emails/Full Website/Brief Booklet	27	27
CIS/no Loz/Emails/Lite Website/Full Booklet	29	29
CIS/no Loz/no Email/Full Website/Full Booklet	30	30
No CIS/Loz/Emails/Full Website/Brief Booklet	36	36
No CIS/Loz/Emails/Lite Website/Full Booklet	36	35
No CIS/Loz/no Emails/Full Website/Full Booklet	37	36
no CIS/no Loz/Emails/Full Website/Full Booklet	38	36
CIS/Loz/Emails/Full Website/Brief Booklet	34	33
CIS/Loz/Emails/Lite Website/Full Booklet	31	30
No CIS/Loz/Emails/Full Website/Full Booklet	35	34
CIS/no Loz/Emails/Full Website/Full Booklet	29	28
CIS/Loz/no Emails/Full Website/Full Booklet	31	30
CIS/Loz/Emails/Full Website/Full Booklet	28	27

Primary outcome: 7-Day Point-Prevalence Abstinence From Smoking

Time frame: Measured after the 3 month follow up assessment. Number. Unit: percentage of participants not smoking

Measure	Cancer Information Service Counseling ("CIS") n = 453	No Cancer Information Service Counseling ("No CIS") n = 581	Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks) n = 518	No Nicotine Replacement Therapy n = 516	Email Messaging n = 526	No Email Messaging n = 508	Full SmokeFree.Gov Website n = 525	Lite SmokeFree.Gov Website n = 509	Full Cessation Booklet n = 517	Brief Cessation Booklet n = 517
Value	27.8	26.3	30.5	23.4	26.2	27.8	29.5	24.4	26.3	27.7

Cancer Information Service Counseling ("CIS") vs No Cancer Information Service Counseling ("No CIS"): Odds Ratio (OR): 1.02 (95% CI 0.88 to 1.17), p = .825, Regression, Logistic
Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks) vs No Nicotine Replacement Therapy: Odds Ratio (OR): 1.17 (95% CI 1.02 to 1.36), p = .028, Regression, Logistic
Email Messaging vs No Email Messaging: Odds Ratio (OR): 1.02 (95% CI 0.85 to 1.13), p = .755, Regression, Logistic

Population analysed: "Intention to treat (ITT)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lozenge	0 of 518 (0%)	0 of 518 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public HealthLink provided by the sponsor.
Smokefree.govLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy B Baker, PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-Day Point-Prevalence Abstinence From Smoking (time frame: Measured after the 3 month follow up assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01342523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.