Telephone Counseling and the Distribution of Nicotine Patches to Smokers

Phase 3

Completed

Conditions: Smoking Cessation

Interventions: Drug: Nicotine Patch
Drug: Placebo
Behavioral: Telephone Counseling
Other: Self-Help Materials

Registration Number: NCT00851357

Lead Sponsor: University of California, San Diego

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4200

Inclusion Criteria

>= 18 years old
Daily smoker
>=6 cigarettes per day
Ready to quit within one month
First time quitline caller
Valid phone number
Valid address (no P.O. boxes)
California resident
Agree to participate in study and evaluation
English or Spanish speaking

Exclusion Criteria

Uses other form of tobacco
Use of Zyban or Chantix
One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Active patches and telephone counseling	Nicotine Patch	Proactive Telephone Counseling and 8-weeks of nicotine patches
Active patches and telephone counseling	Telephone Counseling	Proactive Telephone Counseling and 8-weeks of nicotine patches
Placebo patches and materials	Placebo	8-weeks placebo patches and materials
Telephone counseling	Telephone Counseling	Proactive Telephone Counseling
Placebo patches and telephone counseling	Telephone Counseling	Proactive Telephone Counseling and 8-weeks of placebo patches
Placebo patches and materials	Self-Help Materials	8-weeks placebo patches and materials
Placebo patches and telephone counseling	Placebo	Proactive Telephone Counseling and 8-weeks of placebo patches
Active patches and materials	Self-Help Materials	8-weeks of nicotine patches and materials
Active patches and materials	Nicotine Patch	8-weeks of nicotine patches and materials
Materials	Self-Help Materials	Self-help materials