A Randomized Trial of Internet Access to Nicotine Patches

Smoking Cessation Clinical Trial

— iQS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534404
• Other study ID #: 511
• Secondary ID: R01HL086684-01
• Status: Completed
• Phase: N/A
• First received: September 21, 2007
• Last updated: January 21, 2015
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: January 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 smokers.

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:

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2485
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use Disorder

Intervention

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.
• iQuit Smoking website
Participants will access the Project Quit (iQuit Smoking) website.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Self-reported 30-day Prolonged Abstinence at 9-month Follow up		9 months post randomization	No
Secondary	Self-reported 30-day Prolonged Abstinence at 3-month Follow up		3-months post randomization	No