Clinical trial NCT00851357: Telephone Counseling and the Distribution of Nicotine Patches to Smokers
Official title: The Efficacy of Telephone Counseling and the Centralized Distribution of Nicotine Replacement Therapy Through a Smoking Cessation Quitline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: Nicotine Replacement Therapy
Nicotine Patch
Smoking cessation
Telephone
Tobacco cessation
Counseling
Nicotine
Self-Help
Smoking abstinence
Tobacco Use Disorder
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: California Department of Health Services
First posted: 2009-02-25
Enrollment: 4200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Six-month Continuous Abstinence From Cigarettes
timeFrame: 7 months post enrollment
Secondary outcomes:
measure: Number of Participants Quit for 30-days at 2-months Post Enrollment
timeFrame: 2-months post enrollment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of Californian, San Diego: California Smokers' Helpline
state: California
Study officials:
affiliation: University of California, San Diego
name: Shu-Hong Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: