A Randomized Trial of Internet Access to Nicotine Patches

Study Overview
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Brief Summary
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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
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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.

Official Title
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iQuit Smoking: A Randomized Trial of Internet Access to Nicotine Patches

Conditions
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Smoking Cessation, Tobacco Use Disorder

Intervention / Treatment
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* Drug: Nicotine patches
* Behavioral: Telephone counseling
* Behavioral: iQuit Smoking website


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NRT Patch, Phone Counseling, Internet<br>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. | Drug: Nicotine patches<br>* Participants will wear nicotine patches.<br>* Other names: Nicoderm CQ;Behavioral: Telephone counseling<br>* Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.<br>Behavioral: iQuit Smoking website<br>* Participants will access the Project Quit (iQuit Smoking) website.<br>|
| Active Comparator: Nicotine Patches and Internet<br>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. | Drug: Nicotine patches<br>* Participants will wear nicotine patches.<br>* Other names: Nicoderm CQ;Behavioral: iQuit Smoking website<br>* Participants will access the Project Quit (iQuit Smoking) website.<br>|
| Placebo Comparator: Internet<br>Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website). | Behavioral: iQuit Smoking website<br>* Participants will access the Project Quit (iQuit Smoking) website.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 at 9 Months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 30-day Prolonged Abstinence at 9-month Follow up |  | 9 months post randomization | 
| Self-reported 30-day Prolonged Abstinence at 3-month Follow up |  | 3-months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet-Assisted Tobacco Treatments, Online Smoking Cessation Programs, Nicotine Patches, Telephone Counseling, Smoking Abstinence