Clinical trial NCT00807742: Contingency Management for Smoking in Substance Abusers
Official title: Contingent Vouchers for Smoking in Substance Abusers as Adjunct to Nicotine Patch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: Contingency management for smoking for substance abusers
Contingency reinforcement for smoking abstinence
Contingency Management
Noncontingent Reinforcement
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-12-12
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants Smoking Abstinent in Past 7 Days
timeFrame: 1-month follow-up
measure: Number of Participants Smoking Abstinent in Past 7 Days
timeFrame: 3-month follow up
measure: Number of Participants Smoking Abstinent in Past 7 Days
timeFrame: 6-month follow up
measure: Number of Participants Smoking Abstinent in Past 7 Days
timeFrame: 12-month follow up
measure: Average Number of Cigarettes Per Day
timeFrame: 1-month follow up
measure: Average Number of Cigarettes Per Day
timeFrame: 3-month follow up
measure: Average Number of Cigarettes Per Day
timeFrame: 6-month follow up
measure: Average Number of Cigarettes Per Day
timeFrame: 12-month follow up
measure: Number of Participants With Relapse to Any Heavy Drinking
timeFrame: 1-month follow up
measure: Number of Participants With Relapse to Any Heavy Drinking
timeFrame: 3-month follow up
measure: Number of Participants With Relapse to Any Heavy Drinking
timeFrame: 6-month follow up
measure: Number of Participants With Relapse to Any Heavy Drinking
timeFrame: 12-month follow up
measure: Number of Participants With Relapse to Any Drug Use
timeFrame: 1-month follow up
measure: Number of Participants With Relapse to Any Drug Use
timeFrame: 3-month follow up
measure: Number of Participants With Relapse to Any Drug Use
timeFrame: 6-month follow up
measure: Number of Participants With Relapse to Any Drug Use
timeFrame: 12-month follow up
measure: Percent Smoking Days
timeFrame: 1-month follow up
measure: Percent Smoking Days
timeFrame: 3-month follow up
measure: Percent Smoking Days
timeFrame: 6-month follow up
measure: Percent Smoking Days
timeFrame: 12-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University, Center for Alcohol and Addiction Studies
state: Rhode Island
Study officials:
affiliation: Brown University
name: Damaris Rohsenow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Rosemarie Martin, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.