Contingency Management for Smoking in Substance Abusers

Substance Abuse Clinical Trial

— SCMSUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807742
• Other study ID #: 1R01DA023995-01
• Secondary ID: R01DA023995
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: April 2014

Study information

• Verified date: January 2019
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

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.

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Brown University, Center for Alcohol and Addiction Studies	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 Re — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Average Number of Cigarettes Per Day		1-month follow up
Primary	Average Number of Cigarettes Per Day		3-month follow up
Primary	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
Primary	Average Number of Cigarettes Per Day		12-month follow up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participants With Relapse to Any Drug Use		1-month follow up
Primary	Number of Participants With Relapse to Any Drug Use		3-month follow up
Primary	Number of Participants With Relapse to Any Drug Use		6-month follow up
Primary	Number of Participants With Relapse to Any Drug Use		12-month follow up
Primary	Percent Smoking Days		1-month follow up
Primary	Percent Smoking Days		3-month follow up
Primary	Percent Smoking Days		6-month follow up
Primary	Percent Smoking Days		12-month follow up