Substance-related DisordersPhase 2/3VIPSNCT00607269
Voucher-Based Incentives in a Prevention Setting
A Phase 2/3 study testing Voucher-Based Reinforcement Therapy in people with Substance-related Disorders, run by Friends Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Substance-related Disorders
- What is being tested?
- Voucher-Based Reinforcement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Feb 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Friends Community Center
Los Angeles, California, 90028
About this study
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.
Read the 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.
- Conditions
- Substance-related Disorders
- Being tested
- Voucher-Based Reinforcement Therapy
- Keywords
- Drug Abuse, Contingency management, Voucher-based Reinforcement Therapy, Homosexuality, Homeless Persons
- Medical subject headings
- Substance-Related Disorders, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voucher-Based Reinforcement TherapyBehavioural
Also called VIPS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Voucher-Based Reinforcement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount ($) Earned for Targeted Prosocial and Healthy Behaviors
Participants earned contingency management vouchers for targeted prosocial and healthy behaviors. 1 voucher = $1
Measured: 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.
Measured: 24 Weeks
Secondary outcomes (2)
Self-reported Psychiatric Symptoms at 12-month Follow-up.
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.
Measured: 12 months
Self-reported Sexual Behaviors at 12-month Follow-up
Count of recent (past 30 days) male sexual partners.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startApr 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance-related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Cathy J Reback, Ph.D., Principal investigator, Friends Research Institute, Inc.Jesse B Fletcher, Ph.D., Study director, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607269
- Sponsor's protocol ID
- NIDA 015990
- Other IDs
- R01DA015990
- Acronym
- VIPS
- Status last verified
- Jul 2013
- First submitted
- 22 Jan 2008
- Last updated
- 1 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 20667681Reback 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.
PubMed 22880545Dierst-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.
PubMed 21128876Fletcher 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.
PubMed 27516073
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voucher-Based Incentives in a Prevention Setting
- ClinicalTrials.gov ID
- NCT00607269
- Acronym / sponsor ID
- VIPS / NIDA 015990
- Conditions
- Substance-related Disorders
- Keywords
- Drug Abuse, Contingency management, Voucher-based Reinforcement Therapy, Homosexuality, Homeless Persons
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Posted 1 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control condition receiving minimal incentives for service program attendance and participation. |
| Contingency Management | Experimental | Behavioral: Voucher-Based Reinforcement TherapyContingency 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voucher-Based Reinforcement TherapyAlso: VIPSParticipants 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. | Behavioural | Contingency Management |
Primary outcome
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
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
2 secondary outcomes
Self-reported Psychiatric Symptoms at 12-month Follow-up.
Time frame: 12 months
Self-reported Sexual Behaviors at 12-month Follow-up
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20667681Reback 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.
- Results publication: PubMed 22880545Reback 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.
- Results publication: PubMed 21128876Dierst-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.
- Derived from this study: PubMed 27516073Fletcher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy J Reback, Ph.D. principal investigator
Friends Research Institute, Inc.
Jesse B Fletcher, Ph.D. study director
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Voucher-Based Reinforcement Therapy in people with Substance-related Disorders, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount ($) Earned for Targeted Prosocial and Healthy Behaviors (time frame: 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00607269, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013.