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

December 27, 2009
June 23, 2013
June 2009
May 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01040260 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Low-Cost Contingency Management for Smoking Cessation
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 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Use Cessation
  • Other: Counseling
    Smoking cessation counseling
    Other Name: Smoking cessation counseling
  • Behavioral: Contingency management
    Use of tangible rewards for abstinence from smoking
    Other Name: Low-cost contingency management
  • Drug: Nicotine patches
    Nicotine patches
    Other Name: Nicotine replacement
  • Experimental: Contingency management
    Use of tangible rewards for verified abstinence
    Intervention: Behavioral: Contingency management
  • Active Comparator: Counseling plus nicotine patches
    Counseling plus nicotine patches
    Interventions:
    • Other: Counseling
    • Drug: Nicotine patches
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01040260
17RT-0081
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Timothy P Carmody, Ph.D. University of California, San Francisco
University of California, San Francisco
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP