Clinical trial NCT01736085: Providing Free Nicotine Patches to Quitline Smokers
Official title: Distribution of Voucher vs. Direct Mailing of Nicotine Patches to Quitline Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: tobacco cessation
smoking cessation
nicotine
telephone counseling
self-help
smoking abstinence
tobacco use disorder
nicotine replacement therapy
voucher
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 3706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Six Months Prolonged Abstinence
timeFrame: Seven months post enrollment
Secondary outcomes:
measure: Percentage of Smokers Making a 24-hour Quit Attempt
timeFrame: Two months post enrollment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, 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:
citation: Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutierrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002 Oct 3;347(14):1087-93. doi: 10.1056/NEJMsa020660.
citation: Anderson CM, Zhu SH. Tobacco quitlines: looking back and looking ahead. Tob Control. 2007 Dec;16 Suppl 1(Suppl 1):i81-6. doi: 10.1136/tc.2007.020701.
citation: Cummings KM, Fix BV, Celestino P, Hyland A, Mahoney M, Ossip DJ, Bauer U. Does the number of free nicotine patches given to smokers calling a quitline influence quit rates: results from a quasi-experimental study. BMC Public Health. 2010 Apr 7;10:181. doi: 10.1186/1471-2458-10-181.