Contingency Management for Smoking in Substance Abusers (SCMSUD)

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

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.

Study Overview

• Status: Completed
• Conditions: Substance Abuse
• Intervention / Treatment: Drug: Nicotine Replacement Treatment (NRT); Behavioral: Brief Advice; Behavioral: Contingency Management; Behavioral: Non-Contingent Reinforcement

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.

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown University, Center for Alcohol and Addiction Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management (CM); 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); 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.; Other Names: Nicotine replacement therapy; Nicoderm CQ skin patch; Behavioral: Brief Advice; 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.; Other Names: Smoking counseling; Behavioral: 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.
Active Comparator: Noncontingent Reinforcement (NR); 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); 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.; Other Names: Nicotine replacement therapy; Nicoderm CQ skin patch; Behavioral: Brief Advice; 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.; Other Names: Smoking counseling; Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Damaris Rohsenow, Ph.D., Brown University; Study Director: Rosemarie Martin, Ph.D., Brown University

Publications and helpful links

General Publications

• Rohsenow DJ, Monti PM, Colby SM, Martin RA. Brief interventions for smoking cessation in alcoholic smokers. Alcohol Clin Exp Res. 2002 Dec;26(12):1950-1. doi: 10.1097/01.ALC.0000041006.59547.9A. No abstract available.
• Rohsenow DJ, Martin RA, Tidey JW, Colby SM, Monti PM. Treating Smokers in Substance Treatment With Contingent Vouchers, Nicotine Replacement and Brief Advice Adapted for Sobriety Settings. J Subst Abuse Treat. 2017 Jan;72:72-79. doi: 10.1016/j.jsat.2016.08.012. Epub 2016 Aug 18.
• Mackillop J, Murphy CM, Martin RA, Stojek M, Tidey JW, Colby SM, Rohsenow DJ. Predictive Validity of a Cigarette Purchase Task in a Randomized Controlled Trial of Contingent Vouchers for Smoking in Individuals With Substance Use Disorders. Nicotine Tob Res. 2016 May;18(5):531-7. doi: 10.1093/ntr/ntv233. Epub 2015 Oct 24.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 11, 2008
• First Submitted That Met QC Criteria: December 11, 2008
• First Posted (Estimate): December 12, 2008

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Contingency Management; Contingency management for smoking for substance abusers; Contingency reinforcement for smoking abstinence; Noncontingent Reinforcement
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 1R01DA023995-01 (U.S. NIH Grant/Contract); R01DA023995 (U.S. NIH Grant/Contract)