Tobacco Use DisorderPhase 2NCT00820495
Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
A Phase 2 study testing Web + Phone, Web Only and Phone Only in people with Tobacco Use Disorder, run by Oregon Research Institute at 2 sites in United States.
Trial summary
The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Web + Phone, Web Only and Phone Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,683 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- current users of smokeless tobacco products (snuff or chewing tobacco)
- use of smokeless tobacco products for at least 1 year
- use of at least one tin or pouch per week
- interest in quitting all tobacco
- U.S. resident 18 years of age or older
- ability to read English
Show all 9Show fewer
- willingness to share a phone number, e-mail, and mailing address
- use of personal Internet e-mail account at least once per week
- informed consent
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Research Institute
Eugene, Oregon, 97403
University of California, San Diego
San Diego, California, 92111
About this study
The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.
Read the detailed description
Many Americans engage in the habitual use of smokeless tobacco (ST), and many wish to quit but lack resources. There is a need for innovative, validated, and easily delivered low-cost interventions to facilitate ST cessation in this under-served population of tobacco users. In our current ChewFree study, we have developed a user-friendly, interactive Web-based intervention, and in a randomized trial we have shown this website to be more efficacious than a rigorous control condition that offered Web-based basic textual information on ST cessation. We now seek to extend this proven approach by marrying it with a quitline telephone counseling service that has been used with noteworthy success for smoking abstinence but has not yet been evaluated with ST users. Our 2 x 2 design and large sample size allow us to test both main effects - Web program, phone counseling - as well as explore planned comparisons to examine the value-added contribution of the Web-based intervention to phone counseling, and vice-versa.
This project takes advantage of the opportunity to conduct a study of two tobacco cessation interventions that are growing in use. The use of tobacco help lines is now almost ubiquitous, with more than 30 state and national services now being offered. The use of the Internet for health information and behavior change (including tobacco cessation) has been growing in popularity as well. The proposed project would be an extension of both lines of research, evaluating the relative efficacy of our Internet-based program, telephone counseling, and the combination of both.
We will use a multifaceted promotional plan to recruit more than 2,000 ST users. The recruitment plan builds on the collaborative marketing efforts of a state tobacco control organization and organized promotion through media mailings, on-line advertising, and direct mailing. Follow-up assessment data will be collected electronically via the Internet supplemented by telephone follow-up. Additional data will be derived from phone counselor notes and measures of website usage.
- Conditions
- Tobacco Use Disorder
- Being tested
- Web + Phone, Web Only, Phone Only, Usual Care
- Keywords
- Smokeless tobacco, Chewing Tobacco, Internet, Adolescent
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web + PhoneBehavioural
Also called web-assisted intervention, quitline, helpline
Web + Phone
Web OnlyBehavioural
Also called web-assisted intervention
Web Only
Phone OnlyBehavioural
Also called helpline, quitline
Phone Only
Usual CareBehavioural
Also called helpline, quitline
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| Web + Phone | Experimental | Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling Receives: Behavioral: Web + Phone |
| Web Only | Experimental | Highly interactive tailored Web-based smokeless tobacco cessation program Receives: Behavioral: Web Only |
| Phone Only | Experimental | Phone counseling intervention for smokeless tobacco cessation Receives: Behavioral: Phone Only |
| Control | Experimental | Usual care (initial call plus self-help materials) Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged abstinence from all tobacco
Measured: 3 months and 6 months
Secondary outcomes (2)
7-day point prevalence for smokeless tobacco use
Measured: 3 months and 6 months
7-day point prevalence for all tobacco use
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herbert H. Severson, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820495
- Sponsor's protocol ID
- R01CA084225
- Other IDs
- R01CA084225
- Status last verified
- Aug 2013
- First submitted
- 8 Jan 2009
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Danaher BG, Severson HH, Zhu SH, Andrews JA, Cummins SE, Lichtenstein E, Tedeschi GJ, Hudkins C, Widdop C, Crowley R, Seeley JR. Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation. Internet Interv. 2015 May 1;2(2):143-151. doi: 10.1016/j.invent.2015.02.005.
PubMed 25914872
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
- ClinicalTrials.gov ID
- NCT00820495
- Acronym / sponsor ID
- R01CA084225
- Conditions
- Tobacco Use Disorder
- Keywords
- Smokeless tobacco, Chewing Tobacco, Internet, Adolescent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,683 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, San Diego
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.
Detailed description
Many Americans engage in the habitual use of smokeless tobacco (ST), and many wish to quit but lack resources. There is a need for innovative, validated, and easily delivered low-cost interventions to facilitate ST cessation in this under-served population of tobacco users. In our current ChewFree study, we have developed a user-friendly, interactive Web-based intervention, and in a randomized trial we have shown this website to be more efficacious than a rigorous control condition that offered Web-based basic textual information on ST cessation. We now seek to extend this proven approach by marrying it with a quitline telephone counseling service that has been used with noteworthy success for smoking abstinence but has not yet been evaluated with ST users. Our 2 x 2 design and large sample size allow us to test both main effects - Web program, phone counseling - as well as explore planned comparisons to examine the value-added contribution of the Web-based intervention to phone counseling, and vice-versa.
This project takes advantage of the opportunity to conduct a study of two tobacco cessation interventions that are growing in use. The use of tobacco help lines is now almost ubiquitous, with more than 30 state and national services now being offered. The use of the Internet for health information and behavior change (including tobacco cessation) has been growing in popularity as well. The proposed project would be an extension of both lines of research, evaluating the relative efficacy of our Internet-based program, telephone counseling, and the combination of both.
We will use a multifaceted promotional plan to recruit more than 2,000 ST users. The recruitment plan builds on the collaborative marketing efforts of a state tobacco control organization and organized promotion through media mailings, on-line advertising, and direct mailing. Follow-up assessment data will be collected electronically via the Internet supplemented by telephone follow-up. Additional data will be derived from phone counselor notes and measures of website usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Web + Phone | Experimental | Behavioral: Web + PhoneHighly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling |
| Web Only | Experimental | Behavioral: Web OnlyHighly interactive tailored Web-based smokeless tobacco cessation program |
| Phone Only | Experimental | Behavioral: Phone OnlyPhone counseling intervention for smokeless tobacco cessation |
| Control | Experimental | Behavioral: Usual CareUsual care (initial call plus self-help materials) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- current users of smokeless tobacco products (snuff or chewing tobacco)
- use of smokeless tobacco products for at least 1 year
- use of at least one tin or pouch per week
- interest in quitting all tobacco
- U.S. resident 18 years of age or older
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Web + PhoneAlso: web-assisted intervention, quitline, helplineWeb + Phone | Behavioural | Web + Phone |
| Web OnlyAlso: web-assisted interventionWeb Only | Behavioural | Web Only |
| Phone OnlyAlso: helpline, quitlinePhone Only | Behavioural | Phone Only |
| Usual CareAlso: helpline, quitlineUsual Care | Behavioural | Control |
Primary outcome
Prolonged abstinence from all tobacco
Time frame: 3 months and 6 months
2 secondary outcomes
7-day point prevalence for smokeless tobacco use
Time frame: 3 months and 6 months
7-day point prevalence for all tobacco use
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
- Derived from this study: PubMed 25914872Danaher BG, Severson HH, Zhu SH, Andrews JA, Cummins SE, Lichtenstein E, Tedeschi GJ, Hudkins C, Widdop C, Crowley R, Seeley JR. Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation. Internet Interv. 2015 May 1;2(2):143-151. doi: 10.1016/j.invent.2015.02.005.
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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.
Herbert H. Severson, PhD principal investigator
Oregon Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Web + Phone, Web Only and Phone Only in people with Tobacco Use Disorder, run by Oregon Research Institute at 2 sites 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 9 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 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prolonged abstinence from all tobacco (time frame: 3 months and 6 months). 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 NCT00820495, which also lists 1 linked publication.
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 5 Aug 2013.