- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00252512
The Effect of a Contingency Management Intervention on Substance Use (REAP)
July 19, 2018 updated by: VA Office of Research and Development
Effectiveness of Contingency Management in VA Addictions Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
332
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contingency Management
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.
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.
|
Placebo Comparator: Placebo
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychiatric Status
Time Frame: 8 weeks, 6 months, 12 months
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Kessler Psychological Distress Scale (K10) - score range 10 to 50.
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8 weeks, 6 months, 12 months
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VHA Healthcare Service Utilization
Time Frame: Baseline to 6 month follow up and 6 month follow up to 12 month follow up.
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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.
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Baseline to 6 month follow up and 6 month follow up to 12 month follow up.
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Housing
Time Frame: 8 week, 6 month and 12 month follow-ups
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Number of participants reporting stable housing (owned or rented house, apartment or room)
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8 week, 6 month and 12 month follow-ups
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Legal Status
Time Frame: 8 weeks, 6 month and 12 month follow ups
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Number of participants reporting detention or incarceration in the previous 30 days
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8 weeks, 6 month and 12 month follow ups
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Employment Status
Time Frame: 8 week, 6 month and 12 month follow up
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Number of participants identifying themselves as unemployed.
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8 week, 6 month and 12 month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hildi J. Hagedorn, PhD, Minneapolis VA Health Care System, Minneapolis, MN
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
November 9, 2005
First Submitted That Met QC Criteria
November 9, 2005
First Posted (Estimate)
November 11, 2005
Study Record Updates
Last Update Posted (Actual)
August 16, 2018
Last Update Submitted That Met QC Criteria
July 19, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 03-120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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