Contingency Management for Smoking in Substance Abusers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contingent Vouchers for Smoking in Substance Abusers as Adjunct to Nicotine Patch

Conditions
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Substance Abuse

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


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency Management (CM)<br>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. | Drug: Nicotine Replacement Treatment (NRT)<br>* Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.<br>* Other names: Nicotine replacement therapy;Behavioral: Brief Advice<br>* Brief Advice (BA): Patients will receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.<br>* Other names: Smoking counseling;Behavioral: Contingency Management<br>* 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.<br>|
| Active Comparator: Noncontingent Reinforcement (NR)<br>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. | Drug: Nicotine Replacement Treatment (NRT)<br>* Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.<br>* Other names: Nicotine replacement therapy;Behavioral: Brief Advice<br>* Brief Advice (BA): Patients will receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.<br>* Other names: Smoking counseling;Behavioral: Non-Contingent Reinforcement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Smoking Abstinent in Past 7 Days | 7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. | 1-month follow-up | 
| Number of Participants Smoking Abstinent in Past 7 Days | 7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. | 3-month follow up | 
| Number of Participants Smoking Abstinent in Past 7 Days | 7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. | 6-month follow up | 
| Number of Participants Smoking Abstinent in Past 7 Days | 7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. | 12-month follow up | 
| Average Number of Cigarettes Per Day |  | 1-month follow up | 
| Average Number of Cigarettes Per Day |  | 3-month follow up | 
| Average Number of Cigarettes Per Day | Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period | 6-month follow up | 
| Average Number of Cigarettes Per Day |  | 12-month follow up | 
| Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 1-month follow up | 
| Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 3-month follow up | 
| Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 6-month follow up | 
| Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 12-month follow up | 
| Number of Participants With Relapse to Any Drug Use |  | 1-month follow up | 
| Number of Participants With Relapse to Any Drug Use |  | 3-month follow up | 
| Number of Participants With Relapse to Any Drug Use |  | 6-month follow up | 
| Number of Participants With Relapse to Any Drug Use |  | 12-month follow up | 
| Percent Smoking Days |  | 1-month follow up | 
| Percent Smoking Days |  | 3-month follow up | 
| Percent Smoking Days |  | 6-month follow up | 
| Percent Smoking Days |  | 12-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contingency management for smoking for substance abusers, Contingency reinforcement for smoking abstinence, Contingency Management, Noncontingent Reinforcement