Low-Cost Contingency Management for Smoking Cessation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040260
First received: December 27, 2009
Last updated: June 23, 2013
Last verified: June 2013
  Purpose

An innovative low-cost form of contingency management has been developed in which participants receive the chance to draw vouchers from a fish bowl depending on whether or not their abstinence from tobacco is confirmed by expired-air carbon monoxide. The vouchers can be redeemed for prizes of varying value. This form of contingency management has been shown to be effective in the treatment of a variety of substance use disorders, but has not been investigated in a clinical trial focusing on smoking cessation. Thus, the primary purpose of the proposed study will be to investigate the effects of a low-cost prize-based form of contingency management in the treatment of nicotine dependence. To accomplish this objective, we enrolled 103 current smokers into the study. The participants in Study Arm 1 received the contingency management intervention for 8 weeks, and the participants in Study Arm 2 had their smoking status assessed but did not receive the contingency management intervention. Both interventions received brief counseling and nicotine replacement therapy. The counseling was conducted in two 60-minute individual sessions scheduled one week apart with two follow-up phone calls at weeks 3, 4, and 6.

The primary outcome for this study was biochemically-validated smoking status at 3 months (end of treatment), and at 6- and 12-month follow-up. Both continuous and point-prevalent abstinence rates were determined. Saliva cotinine levels were measured in all participants reporting abstinence at each assessment. This study had 80% power to detect a 10% absolute difference in smoking cessation rates between the two treatment conditions (i.e., a 28% quit rate in Study Arm 1 versus a 18% quit rate in Study Arm 2) with alpha set at 0.05. These estimates included an anticipated 15% loss to follow-up over the 12-month study period.


Condition Intervention
Tobacco Use Cessation
Other: Counseling
Behavioral: Contingency management
Drug: Nicotine patches

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-Cost Contingency Management for Smoking Cessation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Abstinence From Tobacco Use [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Abstinence Rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Verified 7-Day Point-prevalence abstinence rate


Enrollment: 103
Study Start Date: June 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contingency management
Use of tangible rewards for verified abstinence
Behavioral: Contingency management
Use of tangible rewards for abstinence from smoking
Other Name: Low-cost contingency management
Active Comparator: Counseling plus nicotine patches
Counseling plus nicotine patches
Other: Counseling
Smoking cessation counseling
Other Name: Smoking cessation counseling
Drug: Nicotine patches
Nicotine patches
Other Name: Nicotine replacement

Detailed Description:

Contingency management as a treatment for substance use disorders involves the use of tangible rewards for confirmed abstinence. There is preliminary evidence that contingency management shows promise as a smoking cessation intervention. An innovative low-cost form of contingency management has been developed in which participants receive the chance to draw vouchers from a fish bowl depending on whether or not their abstinence from tobacco is confirmed by expired-air carbon monoxide. The vouchers can be redeemed for prizes of varying value. This form of contingency management has been shown to be effective in the treatment of a variety of substance use disorders, but has not been investigated in a clinical trial focusing on smoking cessation. Thus, the primary purpose of the proposed study was to investigate the effects of a low-cost prize-based form of contingency management in the treatment of nicotine dependence. To accomplish this objective, we enrolled 103 current smokers into the study. The participants in Study Arm 1 received the contingency management intervention for 8 weeks, and the participants in Study Arm 2 had their smoking status assessed but did not receive the contingency management intervention. Both interventions received brief counseling and nicotine replacement therapy. The counseling was conducted in two 60-minute individual sessions scheduled one week apart with two follow-up phone calls at weeks 3, 4, and 6.

The primary outcome for this study was biochemically-validated smoking status at 3 months (end of treatment), and at 6- and 12-month follow-up. Both continuous and point-prevalent abstinence rates were determined. Saliva cotinine levels were measured in all participants reporting abstinence at each assessment. This study had 80% power to detect a 10% absolute difference in smoking cessation rates between the two treatment conditions (i.e., a 28% quit rate in Study Arm 1 versus a 18% quit rate in Study Arm 2) with alpha set at 0.05. These estimates included an anticipated 15% loss to follow-up over the 12-month study period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smoke at least 5 cigarettes per day
  • Interested in quitting

Exclusion Criteria:

  • Cognitive impairment or unstable psychotic disorder that would significantly interfere with the individual's ability to participate in the study.
  • Self-reported problem with alcohol or other drugs during the past three months
  • Current use of any smoking cessation medication
  • Presence of any contraindications for nicotine patches, lozenges, or gum
  • Pregnancy
  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: NCT01040260

Locations
United States, California
VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Timothy P Carmody, Ph.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01040260     History of Changes
Other Study ID Numbers: 17RT-0081
Study First Received: December 27, 2009
Results First Received: June 23, 2013
Last Updated: June 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
tobacco use disorder

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014