- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00607269
Voucher-Based Incentives in a Prevention Setting (VIPS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90028
- Friends Community Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-identified, non-treatment seeking, men who have sex with men (MSM) at least 18 years of age and eligible to participate in the VNPD Men's Program. To be eligible to participate in the VNPD Men's Program, a person must report that they have sex with men (or men and women) and actively use drugs or alcohol.
- DSM-IV diagnosis of substance dependence as determined by structured clinical interview for DSM-IV (SCID) on at least one of the following substances: alcohol, marijuana, methamphetamine, cocaine, crack, MDMA (ecstasy), opiates, or dissociative anesthetics (PCP, ketamine). These substances were chosen because they are the ones commonly used by individuals contacted by the VNPD's street outreach workers.
- Ability to understand and provide written informed consent. Also see section D6.1 for consent procedures used with vulnerable populations.
- Able to provide sufficient locator information for follow-up and/or known to VNPD outreach workers.
Exclusion Criteria: Psychiatric health issues requiring a higher level of care.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
Control condition receiving minimal incentives for service program attendance and participation.
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Experimental: Contingency Management
Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
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Participants were randomized into either the CM or control condition. Both conditions earned points for attendance and participation (max 364 points). Participants in the CM condition also earned points for targeted health-promoting behaviors and for drug/alcohol abstinence. CM points for targeted health-promoting behaviors were not limited. Points for abstaining from substance use were awarded based on a Level 1 (recent abstinence for amphetamine, methamphetamine, PCP, and cocaine metabolites, as well as blood alcohol <0.05) urine sample.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount ($) Earned for Targeted Prosocial and Healthy Behaviors
Time Frame: 24 Weeks
|
Participants earned contingency management vouchers for targeted prosocial and healthy behaviors.
1 voucher = $1
|
24 Weeks
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Proportion of Level 1 (i.e., Drug Negative Urines and Alcohol Negative Breath) Clean Urine Samples Provided at 12-month Follow-up, by Condition.
Time Frame: 24 Weeks
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24 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Psychiatric Symptoms at 12-month Follow-up.
Time Frame: 12 months
|
As measured by the General Severity Index (GSI), a summary domain included on the Brief Symptom Inventory.
The GSI combines information on both the number of symptoms described and the severity of those symptoms.
Lower values on the GSI indicate less severe symptoms.
Normative non-patient populations have been shown to have average GSI scores with a mean of 0.30 and a standard deviation of 0.31.
Normative outpatient psychiatric patients have demonstrated GSI scores with a mean of 1.32 with a standard deviation of 0.72.
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12 months
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Self-reported Sexual Behaviors at 12-month Follow-up
Time Frame: 12 months
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Count of recent (past 30 days) male sexual partners.
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jesse B Fletcher, Ph.D., Friends Research Institute, Inc.
Publications and helpful links
General Publications
- Reback CJ, Peck JA, Dierst-Davies R, Nuno M, Kamien JB, Amass L. Contingency management among homeless, out-of-treatment men who have sex with men. J Subst Abuse Treat. 2010 Oct;39(3):255-63. doi: 10.1016/j.jsat.2010.06.007. Epub 2010 Jul 29.
- Reback CJ, Peck JA, Fletcher JB, Nuno M, Dierst-Davies R. Lifetime substance use and HIV sexual risk behaviors predict treatment response to contingency management among homeless, substance-dependent MSM. J Psychoactive Drugs. 2012 Apr-Jun;44(2):166-72. doi: 10.1080/02791072.2012.684633.
- Dierst-Davies R, Reback CJ, Peck JA, Nuno M, Kamien JB, Amass L. Delay-discounting among homeless, out-of-treatment, substance-dependent men who have sex with men. Am J Drug Alcohol Abuse. 2011 Mar;37(2):93-7. doi: 10.3109/00952990.2010.540278. Epub 2010 Dec 6.
- Fletcher JB, Reback CJ. Mental health disorders among homeless, substance-dependent men who have sex with men. Drug Alcohol Rev. 2017 Jul;36(4):555-559. doi: 10.1111/dar.12446. Epub 2016 Aug 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA 015990
- R01DA015990 (U.S. NIH Grant/Contract)
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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