Providing Free Nicotine Patches to Quitline Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shu-Hong Zhu, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01736085
First received: November 15, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Smoking Cessation
Behavioral: Telephone counseling
Behavioral: Voucher
Drug: Nicotine patches
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Distribution of Voucher vs. Direct Mailing of Nicotine Patches to Quitline Smokers

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Smoking Status - six months prolonged abstinence [ Time Frame: Seven months post enrollment ] [ Designated as safety issue: No ]
    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:
  • Percentage of smokers making a 24-hour quit attempt [ Time Frame: Two months post enrollment ] [ Designated as safety issue: No ]
    At the follow up evaluation, subjects will be asked if they have made a quit attempt that lasted at least 24 hours.

  • Survival curves for the quit attempts [ Time Frame: Seven months post enrollment ] [ Designated as safety issue: No ]
    Kaplan-Meier analysis on the quit attempts over a 6 month period.


Estimated Enrollment: 3710
Study Start Date: April 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Material Group
Subjects will receive self-help materials
Active Comparator: Materials plus Voucher
Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches
Behavioral: Voucher

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.

Other Name: Voucher for nicotine patch
Active Comparator: Materials plus Patches
Subjects will receive self-help materials and a 2 week's worth of nicotine patches
Drug: Nicotine patches
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.
Other Name: Nicotine patches sent directly
Active Comparator: Counseling
Subjects will receive up to 5 sessions of telephone counseling
Behavioral: Telephone counseling
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
Active Comparator: Counseling plus Voucher
Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.
Behavioral: Telephone counseling
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
Behavioral: Voucher

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.

Other Name: Voucher for nicotine patch
Active Comparator: Counseling plus Patches
Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.
Behavioral: Telephone counseling
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
Drug: Nicotine patches
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.
Other Name: Nicotine patches sent directly

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736085

Locations
United States, California
University of California, San Diego; California Smokers' Helpline
San Diego, California, United States, 92111
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Shu-Hong Zhu, Ph.D. University of California, San Diego
  More Information

Additional Information:
Publications:
Responsible Party: Shu-Hong Zhu, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01736085     History of Changes
Other Study ID Numbers: P121218
Study First Received: November 15, 2012
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, San Diego:
tobacco cessation
smoking cessation
nicotine
telephone counseling
self-help
smoking abstinence
tobacco use disorder
nicotine replacement therapy
voucher

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014