Contingency Management for Smoking in Substance Abusers

Not Applicable

Completed

Conditions: Substance Abuse

Interventions: Drug: Nicotine Replacement Treatment (NRT)
Behavioral: Brief Advice
Behavioral: Non-Contingent Reinforcement
Behavioral: Contingency Management

Registration Number: NCT00807742

Lead Sponsor: Brown University

Brief Summary: The aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment.

Detailed Description: Substance abusers have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking.

The aim of this study is to determine whether contingent reinforcement for smoking abstinence (CM), compared to noncontingent reinforcement (NR), increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. The proposed study will be a 2-group design in which up to 274 substance abusers who smoke 10 or more cigarettes per day receive brief advice (4 sessions) and nicotine replacement (NRT) (8 weeks), and are randomized to 19 days of CM for smoking vs. a matched NR condition. The brief advice is adapted slightly for sobriety settings. Point-prevalence abstinence will be assessed at 1, 3, 6 and 12 months after starting treatment. Secondary aims evaluate effects of CM on substance use outcomes and potential mediators of effects on outcome, including within-treatment abstinence, motivation level and tolerance for smoking discomfort.

The significance is to add knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this population.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 340

Inclusion Criteria

diagnosis of substance abuse or dependence by DSM-IV criteria
in residential treatment at one particular agency
currently smoking at least 10 cigarettes per day for the past 6 months

Exclusion Criteria

hallucinating or delusional or marked organic impairment (to the point of impairing ability to understand informed consent) according to medical records
current use of nicotine replacement therapy, Zyban, or any other smoking cessation treatment
medical exclusions for NRT: pregnant or nursing; treatment in the last 3 months for unstable angina, severe congestive heart failure, uncontrolled hypertension; lung cancer; supplemental oxygen; history of adverse reactions to NRT; allergies to adhesive; or any severe skin disease that requires treatment (e.g., psoriasis or eczema).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noncontingent Reinforcement (NR)	Nicotine Replacement Treatment (NRT)	Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
Noncontingent Reinforcement (NR)	Brief Advice	Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
Noncontingent Reinforcement (NR)	Non-Contingent Reinforcement	Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
Contingency Management (CM)	Nicotine Replacement Treatment (NRT)	Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Contingency Management (CM)	Brief Advice	Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Contingency Management (CM)	Contingency Management	Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.

Primary Outcome Measures

Name	Time	Method
Number of Participants Smoking Abstinent in Past 7 Days	12-month follow up	7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Average Number of Cigarettes Per Day	12-month follow up
Number of Participants With Relapse to Any Heavy Drinking	12-month follow up	Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Drug Use	12-month follow up
Percent Smoking Days	12-month follow up