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Substance Abuse, IntravenousNCT02487745

The Long-Term Treatment of Drug Addiction and Unemployment

A study testing Abstinence-contingent wage supplements and Individual Placement and Support (IPS) supported employment in people with Substance Abuse, Intravenous, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance Abuse, Intravenous
What is being tested?
Abstinence-contingent wage supplements and Individual Placement and Support (IPS) supported employment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteUnited States
Study dates
Nov 2015to Sep 2020
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • report heroin use

Who cannot join

  • report current suicidal or homicidal ideation;
  • have a severe psychiatric disorder

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Learning and Health

    Baltimore, Maryland, 21224

Other trials in United States

About this study

The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement.

Read the detailed description

Drug addiction is as a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for drug addiction and can maintain drug abstinence over extended periods of time, but practical methods of implementing these interventions are needed. Workplaces could be ideal and practical vehicles for arranging and maintaining abstinence reinforcement over long time periods. The investigator's research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide drug-free urine samples to maintain maximum pay, can maintain drug abstinence. Now what is needed is the development of effective and economically sound methods to arrange long-term exposure to employment-based abstinence reinforcement. The present study will evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement. Under this model, successful Therapeutic Workplace participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. Governments have used wage supplements effectively to increase employment in welfare recipients. The Wage Supplement Model harnesses the power of wage supplements to promote employment, while simultaneously using the wage supplements to reinforce drug abstinence. The intervention will combine the Therapeutic Workplace, Individual Placement and Support (IPS) supported employment, and abstinence-contingent wage supplements. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. Under this model, participants will be exposed to the Therapeutic Workplace to initiate drug abstinence and establish job skills. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. A randomized trial will evaluate the effectiveness and economic benefits of the Abstinence-Contingent Wage Supplement Model in promoting employment and sustaining abstinence in heroin users. Participants will be enrolled in the Therapeutic Workplace for 3 months and then randomly assigned to an IPS Only group or an IPS Plus Abstinence-Contingent Wage Supplement group for one year. IPS Only participants will receive the IPS intervention. IPS Plus Abstinence-Contingent Wage Supplement participants will receive the IPS intervention and abstinence-contingent wage supplements. Drug use while participants are employed in community jobs will be monitored by American Substance Abuse Professionals, Inc. (ASAP®), a leading provider of workplace substance abuse services in the U.S. This novel intervention could be an effective and economically sound way to promote long-term abstinence and employment.

Being tested
Abstinence-contingent wage supplements, Individual Placement and Support (IPS) supported employment
Keywords
Cocaine, Methadone, Employment, Opioids
Medical subject headings
Substance Abuse, Intravenous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abstinence-contingent wage supplementsBehavioural

    Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.

  • Individual Placement and Support (IPS) supported employmentBehavioural

    Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.

Study groups in NCT02487745
Study groupRoleWhat they receive
IPS OnlyActive comparatorIPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Receives: Behavioral: Individual Placement and Support (IPS) supported employment
IPS Plus Wage SupplementExperimentalIPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Receives: Behavioral: Abstinence-contingent wage supplements; Behavioral: Individual Placement and Support (IPS) supported employment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Percentage of Opiate- and Cocaine-negative Urine Samples

    (# opiate- and cocaine-negative urine samples/divided by possible #) x 100

    Measured: 1 year

  2. The Percentage of Participants Who Are Employed

    (# participants employed /divided by total # of participants) x 100

    Measured: 1 year

Secondary outcomes (9)
  1. The Percentage of Participants Who Report Injecting Drugs

    (# participants reporting injecting drugs /divided by total # of participants) x 100

    Measured: 1 year

  2. The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money

    (# participants reporting trading unprotected sex for drugs or money/divided by total # of participants) x 100

    Measured: 1 year

  3. The Percentage of Participants Who Report Sharing Injection Equipment

    (# participants reporting sharing injection equip/divided by total # of participants) x 100

    Measured: 1 year

  4. The Percentage of Participants With Household Incomes Below the Federal Poverty Level

    (# participants with incomes below federal poverty level/divided by total # of participants) x 100

    Measured: 1 year

  5. The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention

    This will be measured after the intervention ends

    Measured: Year 2

  6. The Percentage of Participants Who Are Employed Post-intervention

    This will be measured after the intervention ends

    Measured: Year 2

  7. The Percentage of Participants Who Report Injecting Drugs Post-intervention

    This will be measured after the intervention ends

    Measured: Year 2

  8. The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-intervention

    This will be measured after the intervention ends

    Measured: Year 2

  9. The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention

    This will be measured after the intervention ends

    Measured: Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionSep 2019
  4. Study completionSep 2020

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487745
Sponsor's protocol ID
IRB00046990
Other IDs
R01DA037314-01A1
Status last verified
Jul 2022
First submitted
19 Jun 2015
Last updated
11 Aug 2022
Data monitoring committee
No
Individual data sharing
No: The data will be published in a peer-reviewed journal.

Publications

  • Holtyn AF, Toegel F, Subramaniam S, Jarvis BP, Leoutsakos JM, Fingerhood M, Silverman K. Abstinence-contingent wage supplements to promote drug abstinence and employment: a randomised controlled trial. J Epidemiol Community Health. 2020 May;74(5):445-452. doi: 10.1136/jech-2020-213761. Epub 2020 Feb 21.

    PubMed 32086373

Questions about this trial

What is this clinical trial studying?

A study testing Abstinence-contingent wage supplements and Individual Placement and Support (IPS) supported employment in people with Substance Abuse, Intravenous, run by Johns Hopkins University 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 1 inclusion and 2 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 11 Aug 2022. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2022). 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?

The Percentage of Opiate- and Cocaine-negative Urine Samples (time frame: 1 year). 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 NCT02487745, which also lists 1 linked publication.

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 11 Aug 2022.

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