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Voucher-Based Incentives in a Prevention Setting
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), March 2006
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00607269
  Purpose

This study evaluates a contingency management program that rewards homeless, non-treatment-seeking substance abusing men who have sex with men (MSM) for abstaining from drugs and for performing prosocial behaviors. If this program motivates these individuals to increase prosocial and healthy behaviors and decrease drug/alcohol use, established prevention programs may modify their approaches to include contingency management, and use it to address the staggering public health problems homeless substance-abusing MSMs face on a daily basis.


Condition Intervention Phase
Substance-Related Disorders
Behavioral: Voucher-Based Reinforcement Therapy
Phase II
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Voucher-Based Incentives in a Prevention Setting

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Amount of targeted prosocial and healthy behaviors performed
  • Number of drug negative urines and alcohol negative breath samples provided

Secondary Outcome Measures:
  • Magnitude of reduction in psychiatric symptoms
  • Magnitude of reduction in drug and alcohol use severity
  • Magnitude of reduction in and high-risk sexual and drug use behaviors
  • Proportion of participants demonstrating improved global functioning and well being
  • Baseline to post-intervention alterations in readiness to change

Estimated Enrollment: 144
Study Start Date: April 2005
Detailed Description:

Homelessness is a significant problem plaguing American cities and homeless substance abusers face increased risks. Homeless, substance abusing men who have sex with men (MSM) suffer 80% HIV seroprevalence, engage in the sex trades and resist treatment for substance abuse. For almost 30 years, the Van Ness Recovery House (VNRH) has been providing treatment services to homeless substance-abusing MSMs in Hollywood, CA. In 1994, VNRH began providing community-based HIV prevention services to non-treatment seeking homeless substance-abusing MSMs through the VNPD, its prevention division. Contingency management interventions providing positive incentives for behavior change may be particularly well suited for this disenfranchised, high-risk cohort. Specifically, voucher-based incentive therapies (VBRT) may be particularly effective since they have established potency for increasing prosocial behaviors that successfully compete with taking drugs and for reducing drug use. A randomized, controlled trial will assign 144 non-treatment seeking homeless substance-abusing MSMs at VNPD to either VBRT or control groups (72/group) for 24 weeks, with planned follow up at 7, 9 and 12 months from randomization. The VBRT group will earn vouchers in exchange for completing prosocial and healthy behaviors and/or submitting drug-negative urine and alcohol-negative breath samples. Vouchers will be redeemable for goods located in an onsite voucher store. The control group will receive feedback regarding behaviors performed and urinalysis and breath alcohol tests, but will not receive voucher points for these behaviors. We will assess the efficacy of the VBRT intervention for increasing prosocial and healthy behavior and reducing substance abuse among these non-treatment seeking homeless substance-abusing MSMs receiving services at VNPD. We will also assess the impact of VBRT on other measures of therapeutic change consistent with a harm reduction approach, including reduction of psychiatric symptoms, decreased injection drug use and high-risk sexual behavior, increased participation in prevention programming, improvement in different domains of overall functioning (medical/social/vocational), and increased readiness to change. Additionally, we will examine whether baseline participant characteristics predict VBRT outcomes. Applying VBRT to non-treatment seeking homeless substance-abusing MSMs as well as integrating VBRT into a well-established prevention program with a harm reduction philosophy are both highly innovative. Our reinforcement contingencies will also shape behavioral steps towards more complex behaviors, employing a basic operant tenet that has not received sufficient attention. Overall, our proposed research has the potential to have a significant impact on the public health of the Los Angeles homeless, gay and bisexual community. If VBRT is efficacious for motivating non-treatment seeking homeless substance-abusing MSMs in a community-based prevention program to increase prosocial and healthy behaviors and decrease drug/alcohol use, established prevention programs may modify their approaches to include contingency management, and use it to address the staggering public health problems HGMSAs face on a daily basis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607269

Contacts
Contact: Jonathan B Kamien, Ph.D. 310-312-5036 jkamien@biopsych.com
Contact: Cathy J Reback, Ph.D. 323-463-2295 rebackcj@aol.com

Locations
United States, California
Friends La Brea Recruiting
West Hollywood, California, United States, 90038
Contact: Rhodri Dierst-Davies     323-449-9436     rhodri@biopsych.com    
Contact: Jonathan Kamien, Ph.D.     818 970-0014     jkamien@biopsych.com    
Principal Investigator: Cathy J Reback, Ph.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Leslie Amass, Ph.D. Friends Research Institute, Inc.
Study Director: Cathy J Reback, Ph.D. Friends Research Institute, Inc.
Study Director: Jonathan B Kamien, Ph.D. Friends Research Institute, Inc.
  More Information

Study ID Numbers: NIDA 015990
Study First Received: January 22, 2008
Last Updated: February 4, 2008
ClinicalTrials.gov Identifier: NCT00607269  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Drug Abuse
Contingency management
Voucher-based Reinforcement Therapy
Homosexuality
Homeless Persons

Study placed in the following topic categories:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009