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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Substance Abuse, Intravenous
- 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 group | Role | What they receive |
|---|---|---|
| IPS Only | Active comparator | IPS Only participants will receive the Individual Placement and Support (IPS) supported employment. Receives: Behavioral: Individual Placement and Support (IPS) supported employment |
| IPS Plus Wage Supplement | Experimental | IPS 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.
The Percentage of Opiate- and Cocaine-negative Urine Samples
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
Measured: 1 year
The Percentage of Participants Who Are Employed
(# participants employed /divided by total # of participants) x 100
Measured: 1 year
Secondary outcomes (9)
The Percentage of Participants Who Report Injecting Drugs
(# participants reporting injecting drugs /divided by total # of participants) x 100
Measured: 1 year
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
The Percentage of Participants Who Report Sharing Injection Equipment
(# participants reporting sharing injection equip/divided by total # of participants) x 100
Measured: 1 year
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
The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention
This will be measured after the intervention ends
Measured: Year 2
The Percentage of Participants Who Are Employed Post-intervention
This will be measured after the intervention ends
Measured: Year 2
The Percentage of Participants Who Report Injecting Drugs Post-intervention
This will be measured after the intervention ends
Measured: Year 2
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
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.
- First posted1 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2019
- Study completionSep 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Substance Abuse, IntravenousStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kenneth Silverman, PhD, Principal investigator, Johns Hopkins University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-Term Treatment of Drug Addiction and Unemployment
- ClinicalTrials.gov ID
- NCT02487745
- Acronym / sponsor ID
- IRB00046990
- Conditions
- Substance Abuse, Intravenous
- Keywords
- Cocaine, Methadone, Employment, Opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2015
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 11 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPS Only | Active comparator | Behavioral: Individual Placement and Support (IPS) supported employmentIPS Only participants will receive the Individual Placement and Support (IPS) supported employment. |
| IPS Plus Wage Supplement | Experimental | Behavioral: Abstinence-contingent wage supplements, Behavioral: Individual Placement and Support (IPS) supported employmentIPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- report heroin use
Key exclusion criteria (2 listed)
- report current suicidal or homicidal ideation;
- have a severe psychiatric disorder
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 |
|---|---|---|
| Abstinence-contingent wage supplementsBefore 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. | Behavioural | IPS Plus Wage Supplement |
| Individual Placement and Support (IPS) supported employmentIndividual 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. | Behavioural | IPS Only, IPS Plus Wage Supplement |
Primary outcome
The Percentage of Opiate- and Cocaine-negative Urine Samples
Time frame: 1 year
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
The Percentage of Participants Who Are Employed
Time frame: 1 year
(# participants employed /divided by total # of participants) x 100
9 secondary outcomes
The Percentage of Participants Who Report Injecting Drugs
Time frame: 1 year
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money
Time frame: 1 year
The Percentage of Participants Who Report Sharing Injection Equipment
Time frame: 1 year
The Percentage of Participants With Household Incomes Below the Federal Poverty Level
Time frame: 1 year
The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention
Time frame: Year 2
The Percentage of Participants Who Are Employed Post-intervention
Time frame: Year 2
The Percentage of Participants Who Report Injecting Drugs Post-intervention
Time frame: Year 2
The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money Post-intervention
Time frame: Year 2
The Percentage of Participants Who Report Sharing Injection Equipment Post-intervention
Time frame: Year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32086373Holtyn 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.
- Individual participant dataSharing planned: No. The data will be published in a peer-reviewed journal.
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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.
Kenneth Silverman, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
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.