Providing Free Nicotine Patches to Quitline Smokers

Phase 3

Completed

Conditions: Smoking Cessation

Interventions: Behavioral: Telephone counseling
Behavioral: Voucher
Drug: Nicotine patches

Registration Number: NCT01736085

Lead Sponsor: University of California, San Diego

Brief Summary: The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care. A second factor is counseling plus materials versus materials only. This proposed study has the following specific aims:

1. To demonstrate that a voucher for free nicotine patches will increase the quit rate for smokers who do not have access to free nicotine replacement therapy (NRT)

2. To demonstrate that sending patches directly from a quitline would outperform sending vouchers for free NRT, since the vouchers impose an additional barrier to those who want to quit

3. To determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions

Detailed Description: Tobacco smoking leads to nicotine dependence and serious health consequences. Telephone counseling has been shown to improve smokers' chances of quitting and is the most accessible of the three evidence-based forms of counseling (individual face-to-face, group, and telephone). It is well established that offering free NRT can attract many more smokers to call a quitline. However, how much the offer of free NRT helps quitline callers quit successfully is less well documented. There is currently no consistent guideline for quitline practice. We want to determine whether two weeks' worth of starter kit nicotine patches is efficacious for smokers who don't have access to free nicotine patches or quitting aids. The study also will provide data regarding the impact of a barrier to obtaining quitting aids by contrasting a direct mailing condition with a voucher condition. Further, the study will help us determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions

The study uses a randomized controlled design. Smokers who call the Helpline during the recruitment phase, who meet eligibility requirements for the trial and give consent will be randomly assigned to one of six groups along two factors (nicotine patch and telephone counseling), as described below.

The 6 randomized groups are as follows: Group 1: Materials, Group 2: Voucher + Materials, Group 3: Patches + Materials, Group 4: Counseling, Group 5: Voucher + Counseling, Group 6: Patches + Counseling

Two months and seven months after their initial contact with the Helpline, all participants will receive two Assessment Interviews by phone. The interview will cover, as appropriate, smoking status, use of nicotine patches and other quitting aids, history of quitting, and satisfaction with services provided. The Assessment Interview lasts from 5-10 minutes.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3706

Inclusion Criteria

18 years or older
Current smoker
First time quitline caller
Not eligible for nicotine patches through other programs such as MediCal or Los Angeles County which provides free nicotine patches
English and/or Spanish speaking
Valid phone number
Valid address
CA resident
Gave consent to participate in study and evaluation

Exclusion Criteria

Contraindication(s) to nicotine patches
Uses a form of tobacco other than cigarettes
Plans to use Chantix

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counseling plus Voucher	Telephone counseling	Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.
Materials plus Voucher	Voucher	Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches
Counseling plus Voucher	Voucher	Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.
Materials plus Patches	Nicotine patches	Subjects will receive self-help materials and a 2 week's worth of nicotine patches
Counseling	Telephone counseling	Subjects will receive up to 5 sessions of telephone counseling
Counseling plus Patches	Nicotine patches	Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.
Counseling plus Patches	Telephone counseling	Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Six Months Prolonged Abstinence	Seven months post enrollment	At seven months post enrollment we will conduct a brief telephone survey to assess smoking status. The information obtained will allow us to determine six month prolonged abstinence rates.

Secondary Outcome Measures

Name	Time	Method
Percentage of Smokers Making a 24-hour Quit Attempt	Two months post enrollment	At the follow up evaluation, subjects will be asked if they have made a quit attempt that lasted at least 24 hours.