Providing Free Nicotine Patches to Quitline Smokers
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | July 2015 |
Distribution of Voucher vs. Direct Mailing of Nicotine Patches to Quitline Smokers
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
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
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.
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.
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
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