search
Back to results

Contingency Management for Smoking in Substance Abusers (SCMSUD)

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine Replacement Treatment (NRT)
Brief Advice
Contingency Management
Non-Contingent Reinforcement
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Contingency management for smoking for substance abusers, Contingency reinforcement for smoking abstinence, Contingency Management, Noncontingent Reinforcement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Brown University, Center for Alcohol and Addiction Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Contingency Management (CM)

Noncontingent Reinforcement (NR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Average Number of Cigarettes Per Day
Average Number of Cigarettes Per Day
Average Number of Cigarettes Per Day
Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period
Average Number of Cigarettes Per Day
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Drug Use
Number of Participants With Relapse to Any Drug Use
Number of Participants With Relapse to Any Drug Use
Number of Participants With Relapse to Any Drug Use
Percent Smoking Days
Percent Smoking Days
Percent Smoking Days
Percent Smoking Days

Secondary Outcome Measures

Full Information

First Posted
December 11, 2008
Last Updated
January 16, 2019
Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00807742
Brief Title
Contingency Management for Smoking in Substance Abusers
Acronym
SCMSUD
Official Title
Contingent Vouchers for Smoking in Substance Abusers as Adjunct to Nicotine Patch
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Contingency management for smoking for substance abusers, Contingency reinforcement for smoking abstinence, Contingency Management, Noncontingent Reinforcement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management (CM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Noncontingent Reinforcement (NR)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Treatment (NRT)
Other Intervention Name(s)
Nicoderm CQ skin patch, Nicotine replacement therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice
Other Intervention Name(s)
Smoking counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-Contingent Reinforcement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Smoking Abstinent in Past 7 Days
Description
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Time Frame
1-month follow-up
Title
Number of Participants Smoking Abstinent in Past 7 Days
Description
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Time Frame
3-month follow up
Title
Number of Participants Smoking Abstinent in Past 7 Days
Description
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Time Frame
6-month follow up
Title
Number of Participants Smoking Abstinent in Past 7 Days
Description
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Time Frame
12-month follow up
Title
Average Number of Cigarettes Per Day
Time Frame
1-month follow up
Title
Average Number of Cigarettes Per Day
Time Frame
3-month follow up
Title
Average Number of Cigarettes Per Day
Description
Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period
Time Frame
6-month follow up
Title
Average Number of Cigarettes Per Day
Time Frame
12-month follow up
Title
Number of Participants With Relapse to Any Heavy Drinking
Description
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Time Frame
1-month follow up
Title
Number of Participants With Relapse to Any Heavy Drinking
Description
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Time Frame
3-month follow up
Title
Number of Participants With Relapse to Any Heavy Drinking
Description
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Time Frame
6-month follow up
Title
Number of Participants With Relapse to Any Heavy Drinking
Description
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Time Frame
12-month follow up
Title
Number of Participants With Relapse to Any Drug Use
Time Frame
1-month follow up
Title
Number of Participants With Relapse to Any Drug Use
Time Frame
3-month follow up
Title
Number of Participants With Relapse to Any Drug Use
Time Frame
6-month follow up
Title
Number of Participants With Relapse to Any Drug Use
Time Frame
12-month follow up
Title
Percent Smoking Days
Time Frame
1-month follow up
Title
Percent Smoking Days
Time Frame
3-month follow up
Title
Percent Smoking Days
Time Frame
6-month follow up
Title
Percent Smoking Days
Time Frame
12-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damaris Rohsenow, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosemarie Martin, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Study Director
Facility Information:
Facility Name
Brown University, Center for Alcohol and Addiction Studies
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12500132
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.
Results Reference
background
PubMed Identifier
27658756
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.
Results Reference
background
PubMed Identifier
26498173
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.
Results Reference
result

Learn more about this trial

Contingency Management for Smoking in Substance Abusers

We'll reach out to this number within 24 hrs