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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00252512
First received: November 9, 2005
Last updated: February 6, 2014
Last verified: June 2010
  Purpose

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.


Condition Intervention
Substance Use Disorders
Behavioral: Contingency Management
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Contingency Management in VA Addictions Treatment

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Urine drug and breath alcohol screens during the 8 week intervention period; attendance at treatment appointments during the 8 week intervention period; days abstinent during the prior 30 days at follow-up interviews. [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Employment, housing, legal, and psychiatric status at two, six, and 12 month follow-up interviews; administrative data on VA service utilization at six and 12 month follow-ups. [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 332
Study Start Date: May 2007
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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 ($1, $20 or $80 canteen voucher).
Behavioral: Contingency Management
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 ($1, $20, or $80 canteen voucher).
Placebo Comparator: Arm 2
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
Other: Placebo
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.

Detailed Description:

Objectives: To compare differences between usual care alone and usual care plus contingency management on: 1) negative urine drug and breath alcohol screens over the 8-week intervention period, 2) rates of attendance at scheduled substance use disorders treatment appointments during the 8-week intervention period, and 3) self-reported percent days abstinent at six and 12 month follow-up interviews.

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 $1 (209 of 500), $20 (40 of 500) or $80 (1 of 500). 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.

Significance: This trial will determine the impact on treatment attendance and during and post-treatment abstinence rates of adding a contingency management intervention to standard substance use disorders treatment within the VA. An economic analysis will assess the cost of the contingency management intervention as well any potential savings generated by improved outcomes. In addition to data on extended outcome effects, this trial will provide the research team and participating clinic staff with valuable experience in the process and barriers of establishing contingency management interventions in VA substance use disorders treatment clinics and will inform future implementation and dissemination efforts.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252512

Locations
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Washington
VA Puget Sound Health Care System (116MATCH)
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Principal Investigator: Hildi J. Hagedorn, PhD Minneapolis VA Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00252512     History of Changes
Other Study ID Numbers: IIR 03-120
Study First Received: November 9, 2005
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Contingency management interventions
Substance use disorders treatment
Treatment effectiveness
Randomized clinical trial
Behavioral research

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014