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Substance Use DisordersNCT03519009

A Therapeutic Workplace to Address Poverty and Substance Use

A study testing IPS Plus Abstinence-Contingent Wage Supplement in people with Substance Use Disorders, 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

Addiction is a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for alcohol and drug addiction and can maintain abstinence over extended periods of time, but practical methods of implementing these interventions are needed. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Substance Use Disorders
What is being tested?
IPS Plus Abstinence-Contingent Wage Supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteUnited States
Study dates
2 Jan 2019to 1 Mar 2024
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 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 years or older
  • meet Diagnostic and Statistical Manual (DSM-V) criteria for substance use disorder
  • interested in obtaining employment

Who cannot join

  • suicidal or homicidal ideation
  • meet Diagnostic and Statistical Manual (DSM-V) criteria for psychotic 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

Addiction is a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for alcohol and drug addiction and can maintain 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. Investigators' research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide alcohol- or drug-free urine samples to maintain maximum pay, can maintain alcohol and drug abstinence. Now investigators need to develop effective and economically sound methods to arrange long-term exposure to employment-based abstinence reinforcement. Investigators are proposing to 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 and alcohol abstinence. The intervention will combine 3 elements -- 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 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 drug abstinence. Participants will be enrolled in the Therapeutic Workplace for 3 months and then randomly assigned to a Usual Care Control group or an IPS Plus Abstinence-Contingent Wage Supplement group for one year. Usual Care Control participants will be offered counseling and referrals to employment and treatment programs. IPS Plus Abstinence-Contingent Wage Supplement participants will receive the IPS intervention and abstinence-contingent wage supplements. This novel intervention could be an effective and economically sound way to promote long-term employment and drug abstinence.

Being tested
IPS Plus Abstinence-Contingent Wage Supplement
Keywords
Employment
Medical subject headings
Substance-Related Disorders

What participants receive

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

  • IPS Plus Abstinence-Contingent Wage SupplementBehavioural

    Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements.

Study groups in NCT03519009
Study groupRoleWhat they receive
IPS Plus Abstinence-Contingent Wage SupplementExperimentalAbstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
Receives: Behavioral: IPS Plus Abstinence-Contingent Wage Supplement
Usual Care ControlNo interventionCounseling and referrals to employment and treatment programs.

What is being measured

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

  1. Alcohol Abstinence

    Percentage of participants abstinent per month

    Measured: 1 year

Secondary outcomes (1)
  1. Employment

    Percentage of participants employed per month

    Measured: 1 year

Timeline

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

  1. First posted8 May 2018
  2. Study start2 Jan 2019
  3. Primary completion11 Dec 2022
  4. Study completion1 Mar 2024

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
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03519009
Sponsor's protocol ID
IRB00160297
Other IDs
R01AA024101
Status last verified
Jun 2024
First submitted
26 Apr 2018
Last updated
27 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Novak MD, Toegel F, Holtyn AF, Rodewald AM, Arellano M, Baranski M, Barnett NP, Leoutsakos JM, Fingerhood M, Silverman K. Abstinence-contingent wage supplements for adults experiencing homelessness and alcohol use disorder: A randomized clinical trial. Prev Med. 2023 Nov;176:107655. doi: 10.1016/j.ypmed.2023.107655. Epub 2023 Aug 3.

    PubMed 37541600

Questions about this trial

What is this clinical trial studying?

A study testing IPS Plus Abstinence-Contingent Wage Supplement in people with Substance Use Disorders, 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 3 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 27 Jun 2024. 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 27 Jun 2024). 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?

Alcohol Abstinence (time frame: 1 year). 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 NCT03519009, 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 27 Jun 2024.

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