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The Effect of a Contingency Management Intervention on Substance Use (REAP)

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Contingency management interventions, Substance use disorders treatment, Treatment effectiveness, Randomized clinical trial, Behavioral research

Eligibility Criteria

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

Inclusion Criteria: veterans presenting for outpatient substance use disorders treatment with a diagnosis of alcohol, cocaine, amphetamine, or methamphetamine dependence Exclusion Criteria: primary cannabis dependence primary opioid dependence severe psychiatric symptoms suicide risk positive history or screen for pathological gambling lacking transportation or living too far away to attend twice per week research appointments

Sites / Locations

  • Minneapolis VA Health Care System, Minneapolis, MN
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Contingency Management

Placebo

Arm Description

Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value.

Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.

Outcomes

Primary Outcome Measures

Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16

Secondary Outcome Measures

Psychiatric Status
Kessler Psychological Distress Scale (K10) - score range 10 to 50. score under 20 are likely to be well score 20-24 are likely to have mild psychological distress score 25-29 are likely to have moderate psychological distress score 30 and over are likely to have a severe psychological distress
VHA Healthcare Service Utilization
Cost of total healthcare utilization for six month period between baseline and 6 month follow up and six month period between 6 month and 12 month follow up.
Housing
Number of participants reporting stable housing (owned or rented house, apartment or room)
Legal Status
Number of participants reporting detention or incarceration in the previous 30 days
Employment Status
Number of participants identifying themselves as unemployed.

Full Information

First Posted
November 9, 2005
Last Updated
July 19, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00252512
Brief Title
The Effect of a Contingency Management Intervention on Substance Use
Acronym
REAP
Official Title
Effectiveness of Contingency Management in VA Addictions Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Contingency management interventions involve providing a tangible reward for progress toward treatment goals. The purpose of this study is to determine whether a contingency management intervention added to usual care leads to improved attendance and decreased substance use in patients attending outpatient substance use disorders treatment.
Detailed Description
Design: This will be a randomized, controlled trial. 360 veterans presenting for specialty substance use disorders treatment at the Minneapolis VAMC and the VA Puget Sound Health Care System will be randomly assigned to 8 weeks of Usual Care or Usual Care plus Contingency Management. Minimal exclusion criteria include primary cannabis dependence, primary opioid dependence, screening positive for pathological gambling, serious psychiatric symptoms or suicide risk. Randomization will be stratified by site and primary substance use disorder (alcohol or stimulant). All participants will meet with a research assistant twice per week to submit urine drug and breath alcohol samples. Participants randomized to the contingency management interventions will have the opportunity to draw tokens (with replacement) from a bowl each time they submit negative urine drug and breath alcohol screens. The number of drawings allowed escalates with continuous weeks of negative screens or returns to baseline if screens are positive or missed. Half of the 500 tokens will result in social reinforcement ("Good Job!"). The remainder will earn a VA canteen voucher worth monetary value. Follow-up assessments occur 2, 6, and 12 months after enrollment into the study. Primary outcomes measures include number of days with negative urine drug and breath alcohol screens during the intervention phase, days of treatment attendance during the intervention phase, and percent days abstinent on the Timeline Follow-Back interview at follow-up assessments. Secondary outcomes include a brief assessment of employment, housing, legal, and psychiatric status, and administrative data on VA service utilization. A process evaluation and an economic analysis are included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Contingency management interventions, Substance use disorders treatment, Treatment effectiveness, Randomized clinical trial, Behavioral research

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Contingency Management
Arm Type
Experimental
Arm Description
Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
Primary Outcome Measure Information:
Title
Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Psychiatric Status
Description
Kessler Psychological Distress Scale (K10) - score range 10 to 50. score under 20 are likely to be well score 20-24 are likely to have mild psychological distress score 25-29 are likely to have moderate psychological distress score 30 and over are likely to have a severe psychological distress
Time Frame
8 weeks, 6 months, 12 months
Title
VHA Healthcare Service Utilization
Description
Cost of total healthcare utilization for six month period between baseline and 6 month follow up and six month period between 6 month and 12 month follow up.
Time Frame
Baseline to 6 month follow up and 6 month follow up to 12 month follow up.
Title
Housing
Description
Number of participants reporting stable housing (owned or rented house, apartment or room)
Time Frame
8 week, 6 month and 12 month follow-ups
Title
Legal Status
Description
Number of participants reporting detention or incarceration in the previous 30 days
Time Frame
8 weeks, 6 month and 12 month follow ups
Title
Employment Status
Description
Number of participants identifying themselves as unemployed.
Time Frame
8 week, 6 month and 12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: veterans presenting for outpatient substance use disorders treatment with a diagnosis of alcohol, cocaine, amphetamine, or methamphetamine dependence Exclusion Criteria: primary cannabis dependence primary opioid dependence severe psychiatric symptoms suicide risk positive history or screen for pathological gambling lacking transportation or living too far away to attend twice per week research appointments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hildi J. Hagedorn, PhD
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23453480
Citation
Hagedorn HJ, Noorbaloochi S, Simon AB, Bangerter A, Stitzer ML, Stetler CB, Kivlahan D. Rewarding early abstinence in Veterans Health Administration addiction clinics. J Subst Abuse Treat. 2013 Jul;45(1):109-17. doi: 10.1016/j.jsat.2013.01.006. Epub 2013 Feb 28.
Results Reference
result
PubMed Identifier
25008457
Citation
Hagedorn HJ, Stetler CB, Bangerter A, Noorbaloochi S, Stitzer ML, Kivlahan D. An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers. Addict Sci Clin Pract. 2014 Jul 9;9(1):12. doi: 10.1186/1940-0640-9-12.
Results Reference
result
PubMed Identifier
28673526
Citation
Hagedorn HJ, Noorbaloochi S, Bangerter A, Stitzer ML, Kivlahan D. Health care cost trajectories in the year prior to and following intake into Veterans Health Administration outpatient substance use disorders treatment. J Subst Abuse Treat. 2017 Aug;79:46-52. doi: 10.1016/j.jsat.2017.05.013. Epub 2017 May 25.
Results Reference
result

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The Effect of a Contingency Management Intervention on Substance Use

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