Clinical trial NCT01736085
Conditions: Smoking Cessation
Keywords: tobacco cessation smoking cessation nicotine telephone counseling self-help smoking abstinence tobacco use disorder nicotine replacement therapy voucher
Sponsor: University of California, San Diego
Start date: 2013-04-01; Completion date: 2014-11-01
Enrollment: 3706 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Subjects will receive self-help materials arm 2: Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches arm 3: Subjects will receive self-help materials and a 2 week's worth of nicotine patches arm 4: Subjects will receive up to 5 sessions of telephone counseling arm 5: Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches. arm 6: Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.
Interventions: intervention 1: Telephone counseling intervention 2: Voucher intervention 3: Nicotine patches
Intervention descriptions: intervention 1: Telephone counseling is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling intervention 2: Subjects will receive a voucher for nicotine patches.

Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date. intervention 3: Subjects will receive nicotine patches directly sent to their home. Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.

Protocol documents: