NCT00607269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

August 1, 2013

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

January 22, 2008

Results QC Date

April 19, 2013

Last Update Submit

July 30, 2013

Conditions

Substance-related Disorders

Keywords

Drug AbuseContingency managementVoucher-based Reinforcement TherapyHomosexualityHomeless Persons

Outcome Measures

Primary Outcomes (2)

  • Amount ($) Earned for Targeted Prosocial and Healthy Behaviors

    Participants earned contingency management vouchers for targeted prosocial and healthy behaviors. 1 voucher = $1

    24 Weeks

  • Proportion of Level 1 (i.e., Drug Negative Urines and Alcohol Negative Breath) Clean Urine Samples Provided at 12-month Follow-up, by Condition.

    24 Weeks

Secondary Outcomes (2)

  • Self-reported Psychiatric Symptoms at 12-month Follow-up.

    12 months

  • Self-reported Sexual Behaviors at 12-month Follow-up

    12 months

Study Arms (2)

Control

NO INTERVENTION

Control condition receiving minimal incentives for service program attendance and participation.

Contingency Management

EXPERIMENTAL

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).

Behavioral: Voucher-Based Reinforcement Therapy

Interventions

Voucher-Based Reinforcement TherapyBEHAVIORAL

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.

Also known as: VIPS
Contingency Management

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Community Center

Los Angeles, California, 90028, United States

Location

Related Publications (4)

  • 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.

    PMID: 20667681RESULT

  • 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.

    PMID: 22880545RESULT

  • 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.

    PMID: 21128876RESULT

  • 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.

    PMID: 27516073DERIVED

MeSH Terms

Conditions

Substance-Related DisordersHomosexuality

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSexualitySexual BehaviorBehavior

Results Point of Contact

Title
Jesse B. Fletcher, Ph.D., Statistician
Organization
Friends Research Institute, Inc.
jfletcher@friendsresearch.org
323-463-1601

Study Officials

  • Cathy J Reback, Ph.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

  • Jesse B Fletcher, Ph.D.

    Friends Research Institute, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

April 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

August 1, 2013

Results First Posted

August 1, 2013

Record last verified: 2013-07

Locations

US(1)