Providing Free Nicotine Patches to Quitline Smokers

University of California San Diego

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Behavioral: Voucher; Behavioral: Telephone counseling; Drug: Nicotine patches

Study type: Interventional

Funder types: Other

Identifiers

NCT01736085

P121218

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,706 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,706 participants in 6 patient groups

Material Group

No Intervention group

Description:

Subjects will receive self-help materials

Materials plus Voucher

Active Comparator group

Description:

Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches

Treatment:

Behavioral: Voucher

Materials plus Patches

Active Comparator group

Description:

Subjects will receive self-help materials and a 2 week's worth of nicotine patches

Treatment:

Drug: Nicotine patches

Counseling

Active Comparator group

Description:

Subjects will receive up to 5 sessions of telephone counseling

Treatment:

Behavioral: Telephone counseling

Counseling plus Voucher

Active Comparator group

Description:

Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.

Treatment:

Behavioral: Telephone counseling

Behavioral: Voucher

Counseling plus Patches

Active Comparator group

Description:

Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.

Treatment:

Drug: Nicotine patches

Behavioral: Telephone counseling