Low-Cost Contingency Management for Smoking Cessation

Official Title: “Low-Cost Contingency Management for Smoking Cessation”

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 will enroll 240 current smokers into the study. The participants in Study Arm 1 will receive the contingency management intervention for 8 weeks, and the participants in Study Arm 2 will have their smoking status assessed but will not receive the contingency management intervention. Both interventions will receive brief counseling and nicotine replacement therapy. The counseling will be 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 will be 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 will be determined. Saliva cotinine levels will be measured in all participants reporting abstinence at each assessment. This study will have 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 include an anticipated 15% loss to follow-up over the 12-month study period.

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 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 will enroll 240 current smokers into the study. The participants in Study Arm 1 will receive the contingency management intervention for 8 weeks, and the participants in Study Arm 2 will have their smoking status assessed but will not receive the contingency management intervention. Both interventions will receive brief counseling and nicotine replacement therapy. The counseling will be 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 will be 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 will be determined. Saliva cotinine levels will be measured in all participants reporting abstinence at each assessment. This study will have 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 include an anticipated 15% loss to follow-up over the 12-month study period.

Intervention(s) in this Clinical Trial

• Other: Counseling
  • Smoking cessation counseling
• Behavioral: Contingency management
  • Use of tangible rewards for abstinence from smoking
• Drug: Nicotine patches
  • Nicotine patches

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Contingency management
  • Use of tangible rewards for verified abstinence
• Active Comparator: Counseling plus nicotine patches
  • Counseling plus nicotine patches

Primary Measures

• Abstinence from tobacco use
  • Time Frame: 52 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of California, San Francisco Other

Overall Clinical Trial Officials and Contacts

Timothy P Carmody, Ph.D. Principal Investigator University of California, San Francisco  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01040260

Study ID Number: 17RT-0081

ClinicalTrials.gov Identifier: NCT01040260

Health Authority: United States: Institutional Review Board