Smoking CessationiQSNCT00534404
A Randomized Trial of Internet Access to Nicotine Patches
A study testing Nicotine patches, Telephone counseling and iQuit Smoking website in people with Smoking Cessation and Tobacco Use Disorder, run by University of Michigan at 1 site in United States.
Trial summary
People who smoke cigarettes have an increased risk of developing emphysema, heart disease, and certain types of cancer. This study will evaluate the effectiveness of providing free nicotine patches from an online smoking cessation program, with and without telephone counseling, at improving quit rates in cigarette… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use Disorder
- What is being tested?
- Nicotine patches, Telephone counseling and iQuit Smoking website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,485 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently smokes 10 or more cigarettes per day
- Does not use any tobacco products other than cigarettes
- Willing to set a quit date within 2 to 4 weeks following study entry
- Willing to use a nicotine patch
- Able to speak English
- Access to Internet, email, and telephone at work or home
- Resident of the United States
- Only one person per household is eligible to enroll
Who cannot join
- Medically unable to use the nicotine patch (e.g., pregnant, history of a heart attack)
- Currently uses nicotine replacement therapy (NRT) products
- Currently uses or plans to use Bupropion SR, Wellbutrin, or Zyban
Trial locations and contacts
1 site in 1 country.
About this study
Official title: iQuit Smoking: A Randomized Trial of Internet Access to Nicotine Patches
People who smoke cigarettes have an increased risk of developing emphysema, heart disease, and certain types of cancer. This study will evaluate the effectiveness of providing free nicotine patches from an online smoking cessation program, with and without telephone counseling, at improving quit rates in cigarette smokers.
Read the detailed description
The objective of this project is to determine the efficacy and cost-effectiveness of providing access to free nicotine patches, with or without a required linkage to proactive telephone counseling, as adjuncts to internet-assisted tobacco treatment. Online cessation services will be provided by the Center for Health Communication Research at the University of Michigan.
This investigation has three specific aims and one exploratory aim:
- Specific Aim 1: To determine the efficacy of providing access to free nicotine patches as an addition to online smoking cessation services.
- Specific Aim 2: To determine the efficacy of providing access to free nicotine patches linked with proactive telephone counseling as an addition to online smoking cessation services.
- Specific Aim 3: To determine the cost-effectiveness of providing access to free nicotine patches, with or without linkage to proactive phone counseling, as additions to online cessation services.
- Exploratory Aim 1: To examine potential mediators and moderators of intervention effects. An examination of potential mediators will identify key psychological and behavioral processes (e.g. medication adherence, self-efficacy, etc.) that underlie how the interventions affect the process of quitting and offer guidance regarding key targets for future research. An examination of potential moderators (e.g. level of dependence, income, gender) will identify candidate subgroups for which the proposed interventions may be more effective and cost- effective.
Smokers searching online for help quitting (N=2,475) will be recruited and randomized to receive one of three treatments:
- online smoking cessation services (i.e. web),
- online cessation services plus access to free nicotine patches (i.e.web+patch),
- online cessation services with access to free patches contingent upon participation in proactive telephone counseling (i.e. web+patch+phone).
The Center for Health Communications Research at the University of Michigan will serve as the smoking cessation website for this research project. Developed by Vic Strecher and colleagues, Project Quit is a web-based program designed to help individuals who would like to quit smoking in the next 30 days. The program is grounded in cognitive-behavioral methods of smoking cessation and relapse prevention. The web-based smoking cessation intervention features highly tailored email messages. Once enrolled in the project and the baseline assessment is completed, participants receive six tailored web sessions namely:
- Action plan (1 week before quit date);
- Barriers 1 (2 days before quit date);
- Supportive message (on quit date);
- Barriers 2 (2 days after quit date);
- Motivation (1 week after quit date);
- Testimonial (2 weeks after quit date).
Evaluations will occur at baseline and at 1-, 3-, and 9-months post-enrollment. The primary outcome measure will be self-reported 6-month prolonged abstinence measured at the 9-month evaluation.
This proposal addresses a critical need for evidence-based cessation treatments for smokers. At the completion of this project, it is our expectation that we will have identified an effective online intervention package (or packages) for dissemination of internet-assisted tobacco treatment.
This study will enroll people recruited via online sources. Participants will complete a baseline survey about their smoking habits and quit history. Participants will then be randomly assigned to one of the following three treatment groups:
- Group 1 participants will receive access to an online tailored stop smoking program.
- Group 2 participants will receive free access to nicotine patches and an online tailored stop smoking program.
- Group 3 participants will receive telephone counseling, free access to nicotine patches and an online tailored stop smoking program.
Participants receiving telephone counseling will receive 5 phone calls over a 2-month period to discuss their personal smoking cessation plan; they must complete the pre-quit and 7-10 day calls in order to receive the nicotine patches. At 1, 3, and 9 months post-enrollment, all participants will complete online surveys about their smoking cessation experience. Participants will be contacted by phone to complete the surveys if they do not complete them online.
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Being tested
- Nicotine patches, Telephone counseling, iQuit Smoking website
- Keywords
- Internet-Assisted Tobacco Treatments, Online Smoking Cessation Programs, Nicotine Patches, Telephone Counseling, Smoking Abstinence
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchesDrug
Also called Nicoderm CQ
Participants will wear nicotine patches.
Telephone counselingBehavioural
Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
iQuit Smoking websiteBehavioural
Participants will access the Project Quit (iQuit Smoking) website.
| Study group | Role | What they receive |
|---|---|---|
| NRT Patch, Phone Counseling, Internet | Experimental | As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks. Receives: Drug: Nicotine patches; Behavioral: Telephone counseling; Behavioral: iQuit Smoking website |
| Nicotine Patches and Internet | Active comparator | As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks. Receives: Drug: Nicotine patches; Behavioral: iQuit Smoking website |
| Internet | Placebo comparator | Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website). Receives: Behavioral: iQuit Smoking website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported 6-month Prolonged Abstinence From Smoking
Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.
Measured: Measured at 9 Months post-randomization
Secondary outcomes (2)
Self-reported 30-day Prolonged Abstinence at 9-month Follow up
Measured: 9 months post randomization
Self-reported 30-day Prolonged Abstinence at 3-month Follow up
Measured: 3-months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startMar 2011
- Primary completionMar 2014
- Study completionMar 2014
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 MichiganThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,485 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Lawrence C. An, University of Michigan
- Investigators
- Lawrence C An, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534404
- Sponsor's protocol ID
- 511
- Other IDs
- R01HL086684-01
- Acronym
- iQS
- Status last verified
- Jan 2015
- First submitted
- 21 Sep 2007
- Last updated
- 3 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iQuit Smoking: A Randomized Trial of Internet Access to Nicotine Patches
- ClinicalTrials.gov ID
- NCT00534404
- Acronym / sponsor ID
- iQS / 511
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Keywords
- Internet-Assisted Tobacco Treatments, Online Smoking Cessation Programs, Nicotine Patches, Telephone Counseling, Smoking Abstinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,485 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Posted 3 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who smoke cigarettes have an increased risk of developing emphysema, heart disease, and certain types of cancer. This study will evaluate the effectiveness of providing free nicotine patches from an online smoking cessation program, with and without telephone counseling, at improving quit rates in cigarette smokers.
Detailed description
The objective of this project is to determine the efficacy and cost-effectiveness of providing access to free nicotine patches, with or without a required linkage to proactive telephone counseling, as adjuncts to internet-assisted tobacco treatment. Online cessation services will be provided by the Center for Health Communication Research at the University of Michigan.
This investigation has three specific aims and one exploratory aim:
- Specific Aim 1: To determine the efficacy of providing access to free nicotine patches as an addition to online smoking cessation services.
- Specific Aim 2: To determine the efficacy of providing access to free nicotine patches linked with proactive telephone counseling as an addition to online smoking cessation services.
- Specific Aim 3: To determine the cost-effectiveness of providing access to free nicotine patches, with or without linkage to proactive phone counseling, as additions to online cessation services.
- Exploratory Aim 1: To examine potential mediators and moderators of intervention effects. An examination of potential mediators will identify key psychological and behavioral processes (e.g. medication adherence, self-efficacy, etc.) that underlie how the interventions affect the process of quitting and offer guidance regarding key targets for future research. An examination of potential moderators (e.g. level of dependence, income, gender) will identify candidate subgroups for which the proposed interventions may be more effective and cost- effective.
Smokers searching online for help quitting (N=2,475) will be recruited and randomized to receive one of three treatments:
- online smoking cessation services (i.e. web),
- online cessation services plus access to free nicotine patches (i.e.web+patch),
- online cessation services with access to free patches contingent upon participation in proactive telephone counseling (i.e. web+patch+phone).
The Center for Health Communications Research at the University of Michigan will serve as the smoking cessation website for this research project. Developed by Vic Strecher and colleagues, Project Quit is a web-based program designed to help individuals who would like to quit smoking in the next 30 days. The program is grounded in cognitive-behavioral methods of smoking cessation and relapse prevention. The web-based smoking cessation intervention features highly tailored email messages. Once enrolled in the project and the baseline assessment is completed, participants receive six tailored web sessions namely:
- Action plan (1 week before quit date);
- Barriers 1 (2 days before quit date);
- Supportive message (on quit date);
- Barriers 2 (2 days after quit date);
- Motivation (1 week after quit date);
- Testimonial (2 weeks after quit date).
Evaluations will occur at baseline and at 1-, 3-, and 9-months post-enrollment. The primary outcome measure will be self-reported 6-month prolonged abstinence measured at the 9-month evaluation.
This proposal addresses a critical need for evidence-based cessation treatments for smokers. At the completion of this project, it is our expectation that we will have identified an effective online intervention package (or packages) for dissemination of internet-assisted tobacco treatment.
This study will enroll people recruited via online sources. Participants will complete a baseline survey about their smoking habits and quit history. Participants will then be randomly assigned to one of the following three treatment groups:
- Group 1 participants will receive access to an online tailored stop smoking program.
- Group 2 participants will receive free access to nicotine patches and an online tailored stop smoking program.
- Group 3 participants will receive telephone counseling, free access to nicotine patches and an online tailored stop smoking program.
Participants receiving telephone counseling will receive 5 phone calls over a 2-month period to discuss their personal smoking cessation plan; they must complete the pre-quit and 7-10 day calls in order to receive the nicotine patches. At 1, 3, and 9 months post-enrollment, all participants will complete online surveys about their smoking cessation experience. Participants will be contacted by phone to complete the surveys if they do not complete them online.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NRT Patch, Phone Counseling, Internet | Experimental | Drug: Nicotine patches, Behavioral: Telephone counseling, Behavioral: iQuit Smoking websiteAs adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks. |
| Nicotine Patches and Internet | Active comparator | Drug: Nicotine patches, Behavioral: iQuit Smoking websiteAs adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks. |
| Internet | Placebo comparator | Behavioral: iQuit Smoking websiteResearch participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Currently smokes 10 or more cigarettes per day
- Does not use any tobacco products other than cigarettes
- Willing to set a quit date within 2 to 4 weeks following study entry
- Willing to use a nicotine patch
- Able to speak English
Key exclusion criteria (3 listed)
- Medically unable to use the nicotine patch (e.g., pregnant, history of a heart attack)
- Currently uses nicotine replacement therapy (NRT) products
- Currently uses or plans to use Bupropion SR, Wellbutrin, or Zyban
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 |
|---|---|---|
| Nicotine patchesAlso: Nicoderm CQParticipants will wear nicotine patches. | Drug | NRT Patch, Phone Counseling, Internet, Nicotine Patches and Internet |
| Telephone counselingParticipants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan. | Behavioural | NRT Patch, Phone Counseling, Internet |
| iQuit Smoking websiteParticipants will access the Project Quit (iQuit Smoking) website. | Behavioural | Internet, NRT Patch, Phone Counseling, Internet, Nicotine Patches and Internet |
Primary outcome
Self-reported 6-month Prolonged Abstinence From Smoking
Time frame: Measured at 9 Months post-randomization
Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.
2 secondary outcomes
Self-reported 30-day Prolonged Abstinence at 9-month Follow up
Time frame: 9 months post randomization
Self-reported 30-day Prolonged Abstinence at 3-month Follow up
Time frame: 3-months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lawrence C An, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patches, Telephone counseling and iQuit Smoking website in people with Smoking Cessation and Tobacco Use Disorder, run by University of Michigan at 1 site in United States.
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 8 inclusion and 3 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 3 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2015). 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?
Self-reported 6-month Prolonged Abstinence From Smoking (time frame: Measured at 9 Months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2015.