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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00252512 |
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 |
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Substance Use Disorders |
Behavioral: Contingency Management Other: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effectiveness of Contingency Management in VA Addictions Treatment |
Estimated Enrollment: | 360 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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).
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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).
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2: Placebo Comparator
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
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Other: Placebo
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tabitha R Leighton, BA MPH | (612) 629-7421 | tabitha.leighton@va.gov |
Contact: Eliza McManus, BA | (612) 629-2720 | eliza.mcmanus@va.gov |
United States, Minnesota | |
VA Medical Center | Recruiting |
Minneapolis, Minnesota, United States, 55417 | |
Contact: Jill A Johnson, BA 612-467-3887 jill.johnson4@va.gov | |
Contact: Hildi J Hagedorn, PhD (612) 467-3875 hildi.hagedorn@med.va.gov | |
Sub-Investigator: Hanna E. Bloomfield, MD MPH | |
Principal Investigator: Hildi J. Hagedorn, PhD | |
United States, Washington | |
VA Puget Sound Health Care System (116MATCH) | Recruiting |
Seattle, Washington, United States, 98108 | |
Contact: Jane E Summerfield, MA 206-764-2848 jane.summerfield@med.va.gov | |
Contact: Daniel R Kivlahan, PhD (206) 768-5483 daniel.kivlahan@med.va.gov | |
Sub-Investigator: Daniel R. Kivlahan, PhD | |
Sub-Investigator: Carl T. Rimmele, PhD |
Principal Investigator: | Hildi J. Hagedorn, PhD | Minneapolis Veterans Affairs Medical Center |
Responsible Party: | Department of Veterans Affairs ( Hagedorn, Hildi - Principal Investigator ) |
Study ID Numbers: | IIR 03-120 |
Study First Received: | November 9, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00252512 |
Health Authority: | United States: Federal Government |
Contingency management interventions Substance use disorders treatment Treatment effectiveness Randomized clinical trial Behavioral research |
Behavior, Addictive Mental Disorders Substance-Related Disorders Disorders of Environmental Origin |