Low-Cost Contingency Management for Smoking Cessation

Tobacco Use Cessation Clinical Trial

Official title:

Low-Cost Contingency Management for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040260
• Other study ID #: 17RT-0081
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Other:
• Counseling
Smoking cessation counseling

Behavioral:
• Contingency management
Use of tangible rewards for abstinence from smoking

Drug:
• Nicotine patches
Nicotine patches

Locations

Country	Name	City	State
United States	VA Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence Rate	Number of participants who abstained from smoking during the 7 day period verified by CO testing	52 weeks