Clinical trial NCT00851357
Conditions: Smoking Cessation
Keywords: Nicotine Replacement Therapy Nicotine Patch Smoking cessation Telephone Tobacco cessation Counseling Nicotine Self-Help Smoking abstinence Tobacco Use Disorder
Sponsor: University of California, San Diego
Start date: 2009-02-01; Completion date: 2011-12-01
Enrollment: 4200 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:

1. Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
2. Test if sending placebo patches directly will also lead to a higher quit rate.
3. Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.

Detailed description:
Studies have shown that statewide tobacco quitlines can dramatically increase call volume by offering direct mailings of free nicotine replacement therapy (NRT) products. Sending free NRT such as patches to quitline callers, however, often requires a large budget because quitlines have a large number of smokers calling for help each year. A strong rationale is needed for state funding agencies to pay for the patches, which are generally considered the responsibility of health plans. This study will contrast the condition of sending nicotine patches directly from the quitline with a condition where the quitline assists smokers to obtain patches by other means, primarily through their health plans. The study aims to demonstrate that sending patches immediately after smokers call the quitline has a motivational effect that will lead to a higher quit rate than if smokers have to obtain the patches themselves, even if they are able to obtain them for free. To tease apart how much of the effect of sending patches directly from the quitline is due to the active ingredient in the patches and how much is due to motivational effects, this study adds a placebo condition. We hypothesize that the active patches condition will outperform the placebo condition, and the sending of placebo patches will outperform the condition in which the smokers obtain the nicotine patches themselves. We also hypothesize that counseling has its own effect on quitting above and beyond that of the nicotine patches. This study will supply data that can be used to decide what role nicotine replacement therapy should play in publicly funded tobacco cessation programs. Results will also add to the theoretical understanding of behavior change from which new, effective interventions can spring.

Arms: arm 1: Proactive Telephone Counseling and 8-weeks of nicotine patches arm 2: Proactive Telephone Counseling and 8-weeks of placebo patches arm 3: Proactive Telephone Counseling arm 4: 8-weeks of nicotine patches and materials arm 5: 8-weeks placebo patches and materials arm 6: Self-help materials
Interventions: intervention 1: Nicotine Patch intervention 2: Telephone Counseling intervention 3: Placebo intervention 4: Self-Help Materials
Intervention descriptions: intervention 1: Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches. intervention 2: Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.

Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. intervention 3: Placebo nicotine patch intervention 4: Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.

Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.

Protocol documents: