A Randomized Trial of Internet Access to Nicotine Patches

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.

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:

1. online smoking cessation services (i.e. web),

2. online cessation services plus access to free nicotine patches (i.e.web+patch),

3. 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 follow-up. 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 who accessed the Quitnet.com Web site. 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 free access to nicotine patches, telephone counseling, and Quitnet.com services. - Group 2 participants will receive free access to nicotine patches and Quitnet.com services. - Group 3 participants will receive Quitnet.com services.

Participants receiving telephone counseling will receive three phone calls over a 2-week period to discuss their personal smoking cessation plan; they must complete all three calls in order to receive the nicotine patches. At Months 1, 3, and 9, 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.

Intervention(s) in this Clinical Trial

• Drug: Nicotine patches
  • Participants will wear nicotine patches.
• Behavioral: Telephone counseling
  • Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
• Behavioral: iQuit Smoking website
  • Participants will access the Project Quit (iQuit Smoking) website.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Nicotine Patches, Telephone Counseling, and Internet
  • As adjuncts to an internet-assisted tobacco treatment 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.
• Active Comparator: Nicotine Patches and Internet
  • As adjuncts to an internet-assisted tobacco treatment, 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.
• Placebo Comparator: Internet
  • Research participants in this arm will have free access to internet-assisted tobacco treatment website.

Primary Measures

• Self-reported 6-month prolonged abstinence from smoking
  • Time Frame: Measured at Month 9
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of Michigan Other

Overall Clinical Trial Officials and Contacts

Lawrence C An, MD Principal Investigator University of Michigan  

Overall Contact: Larry C. An, MD 877-649-4195 iqsadministration@umich.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00534404

Study ID Number: 511

ClinicalTrials.gov Identifier: NCT00534404

Health Authority: United States: Federal Government