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Low-Cost Contingency Management for Smoking Cessation

2014-07-23 21:11:16 | BioPortfolio

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 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.

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 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tobacco Use Cessation

Intervention

Counseling, Contingency management, Nicotine patches

Location

VA Medical Center
San Francisco
California
United States
94121

Status

Recruiting

Source

University of California, San Francisco

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:16-0400

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Medical and Biotech [MESH] Definitions

Cessation of the habit of using tobacco products for smoking or chewing, including the use of snuff.

Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

Items used to aid in ending a TOBACCO habit.

A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.

The N-glucuronide conjugate of cotinine is a major urinary metabolite of NICOTINE. It thus serves as a biomarker of exposure to tobacco SMOKING. It has CNS stimulating properties.

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