Telephone Counseling and the Distribution of Nicotine Patches to Smokers

University of California San Diego

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00851357

CDPH 05-45834

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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4,200 participants in 6 patient groups, including a placebo group

Active patches and telephone counseling

Experimental group

Description:

Proactive Telephone Counseling and 8-weeks of nicotine patches

Treatment:

Behavioral: Telephone Counseling

Drug: Nicotine Patch

Placebo patches and telephone counseling

Placebo Comparator group

Description:

Proactive Telephone Counseling and 8-weeks of placebo patches

Treatment:

Behavioral: Telephone Counseling

Drug: Placebo

Telephone counseling

Active Comparator group

Description:

Proactive Telephone Counseling

Treatment:

Behavioral: Telephone Counseling

Active patches and materials

Active Comparator group

Description:

8-weeks of nicotine patches and materials

Treatment:

Other: Self-Help Materials

Drug: Nicotine Patch

Placebo patches and materials

Active Comparator group

Description:

8-weeks placebo patches and materials

Treatment:

Other: Self-Help Materials

Drug: Placebo

Materials

Active Comparator group

Description:

Self-help materials

Treatment:

Other: Self-Help Materials