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Veterans With Opioid Use DisorderTHRIVENCT05388812

Together in Recovery With Veterans Through Employment

A study testing Treatment As Usual Vocational Rehabilitation (TAU-VR) and Individual Placement and Support (IPS) in people with Veterans With Opioid Use Disorder, run by VA Office of Research and Development at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to help Veterans who have opioid use problems with gaining and maintaining meaningful employment. The investigators also want to know employment helps with other aspects of the Veteran's life including starting and staying on necessary medications, mental health needs, and feeling a part… Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Veterans With Opioid Use Disorder
What is being tested?
Treatment As Usual Vocational Rehabilitation (TAU-VR) and Individual Placement and Support (IPS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
2 sitesUnited States
Study dates
16 Dec 2022to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age 19* (<19 year of age in the state of AL is defined minor)
  • DSM-5 Axis I diagnosis of OUD
  • currently unemployed or underemployed, defined as working <20hrs/week in a meaningful competitive job for a wage, salary, or commission
  • expression of interest in competitive employment; and willing and able to give informed consent

Who cannot join

  • current diagnosis of psychotic disorders since these Veterans already can receive IPS in usual care at TVAMC and BVAMC
  • diagnosis of dementia (evidenced in the medical record)
  • presence of current severe and unstable medical condition or terminal illness, that would contraindicate study participation or expose them to an undue risk
  • unlikely that participant can complete the study
  • e.g., expected deployment, incarceration, long-term hospitalization, or relocation from the vicinity
  • active suicidal or homicidal ideation making it unsafe for Veteran to be included
  • current participation in another vocational interventional trial

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Birmingham VA Medical Center, Birmingham, AL

    Birmingham, Alabama, 35233-1927

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL

    Tuscaloosa, Alabama, 35404-5015

Other trials in United States

About this study

Official title: Individual Placement and Support for Veterans With Opioid Use Disorder: A Mixed Methods Study

The purpose of this study is to help Veterans who have opioid use problems with gaining and maintaining meaningful employment. The investigators also want to know employment helps with other aspects of the Veteran's life including starting and staying on necessary medications, mental health needs, and feeling a part of society.

Read the detailed description

The primary aim of this study is to evaluate the employment outcomes of Individual Placement and Support (IPS) compared to Treatment-as-Usual Vocational Rehabilitation (TAU-VR) in 120 Veterans who are recovering from opioid use disorder (OUD) over 15 months. Specifically, the investigators will see which treatment yields more weeks worked in a competitive job with the hypothesis that IPS will result in better outcomes than TAU-VR. The investigators will interview Veterans in both IPS and TAU-VR groups to investigate the contextual barriers and facilitators of implementing vocational services among Veterans with OUD with the aim to provide solutions and leverage facilitators of success as the VHA expands supported employment services to a new priority population. Investigators will evaluate the impact of vocational services on adherence to prescribed treatment and OUD relapse rates. This study is especially timely given the societal impact of the COVID-19 pandemic on employment and occupational functioning.

Being tested
Treatment As Usual Vocational Rehabilitation (TAU-VR), Individual Placement and Support (IPS)
Keywords
Veteran, opioid use disorder, employment, social support, mental health
Medical subject headings
Opioid-Related Disorders, Psychological Well-Being

What participants receive

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

  • Treatment As Usual Vocational Rehabilitation (TAU-VR)Other

    TAU-VR Services may include 1) Compensated Work Therapy-Transitional Work (CWT-TW) assignment in a set-aside, minimum-wage, short-term job, typically in the VA setting (approximately 50% of the Veterans randomized to TW in past studies conducted by the investigators actually engaged in TW assignment) or 2) CWT-Community-Based Employment Services (CWT-CBES) which involves a community job search, placement in a competitive job, with limited follow-along support that typically ends after the Veteran is working in his/her first job

  • Individual Placement and Support (IPS)Other

    The IPS model involves the following important domains: competitive employment, eligibility based on client choice of employment, integration of IPS and treatment team personalized counseling, rapid job search, systematic job development, and time-unlimited and individualized support.

Study groups in NCT05388812
Study groupRoleWhat they receive
Individual Placement and SupportExperimentalThe IPS model involves the following important domains: competitive employment, eligibility based on client choice of employment, integration of IPS and treatment team personalized counseling, rapid job search, systematic job development, and time-unlimited and individualized support.
Receives: Other: Individual Placement and Support (IPS)
Treatment As Usual Vocational Rehabilitation (TAU-VR)Active comparatorTAU-VR Services may include 1) Compensated Work Therapy-Transitional Work (CWT-TW) assignment in a set-aside, minimum-wage, short-term job, typically in the VA setting (approximately 50% of the Veterans randomized to TW in past studies conducted by the investigators actually engaged in TW assignment) or 2) CWT-Community-Based Employment Services (CWT-CBES) which involves a community job search, placement in a competitive job, with limited follow-along support that typically ends after the Veteran is working in his/her first job
Receives: Other: Treatment As Usual Vocational Rehabilitation (TAU-VR)

What is being measured

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

  1. number of weeks worked

    A "week worked" is defined as working either part time or full time in a competitive job during a Sunday to Saturday 7-day window. Competitive employment is defined as a job that pays at least minimum wage or is based on salary or commission, is based in a setting alongside others without disabilities, and is not reserved for people with disabilities

    Measured: 15 months

Secondary outcomes (5)

  1. Quality of Life

    Veteran quality of life will be measures by a 16-item self-report quality of life scale by Burckhardt and Anderson. Scores range from 16 to 112. Higher numbers mean better quality of life. According to the authors, the average score of a healthy adult is 90. Therefore anything above 90 should be considered good.

    Measured: 15 months

  2. social support

    the Veterans perceived social support will be measured by the 37-item self-report community assessment inventory by Salari et al. There are four domains: household, (six items), family (10 items), friends 8 items), and community (13 items). scores can be calculated for each domain or on a total scale. for the total scale scores range from. Higher numbers mean higher perceived social support. No specific guidance on what is considered good or poor social support.

    Measured: 15 months

  3. Depression

    the Veterans depressive symptoms will be measured by the 9-item self-report Patient Health Questionnaire-9 by Pfitzer. Scores range from 1-27. Higher numbers mean more depressive symptoms. 1-4 is considered minimal depression; 5-9 is considered mild depression; 10-14 is considered moderate depression; 15-19 is considered moderately severe depression; and 20-27 is considered severe depression.

    Measured: 15 months

  4. Anxiety

    the Veterans anxiety will be measured by the 7-item self-report Generalized Anxiety Disorder-7 questionnaire by Spitzer et al. Scores range from zero to 21. Higher numbers mean more anxiety. zero to 4 is considered minimal anxiety; 5-9 is considered mild anxiety; 10-14 is considered moderate anxiety, and 15-21 is considered severe anxiety.

    Measured: 15 months

  5. Resilience

    the Veterans resilience will be measured by the 6-item self-report Brief Resilience Scale questionnaire by Smith et al. scores range from zero to 30 and then averaged by the number of questions answered. Therefore final scores averages range rom zero to 5. Higher mean scores reflect more resilience. The authors of the questionnaire do not provide any guidance on what is considered high, medium, or low resilience.

    Measured: 15 months

Timeline

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

  1. First posted24 May 2022
  2. Study start16 Dec 2022
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
eligible and consenting participants will be randomized to either individual placement and support (IPS) or treatment as usual vocational rehabilitation (TAU-VR).
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388812
Sponsor's protocol ID
D3656-R
Acronym
THRIVE
Status last verified
Mar 2026
First submitted
19 May 2022
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Treatment As Usual Vocational Rehabilitation (TAU-VR) and Individual Placement and Support (IPS) in people with Veterans With Opioid Use Disorder, run by VA Office of Research and Development at 2 sites 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

number of weeks worked (time frame: 15 months). 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 NCT05388812.

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 19 Mar 2026.

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