Vocational Rehabilitation for Opioid Use Disorder

(THRIVE Trial)

Recruiting at 1 trial location

Overseen By Lori L Davis, MD AB

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorders, Dementia, Severe medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how assisting Veterans with opioid use issues in finding and maintaining meaningful jobs can enhance their overall well-being. The study compares two approaches: the Individual Placement and Support (IPS) model, which provides personalized, long-term support for securing competitive employment, and the usual vocational rehabilitation services (Treatment As Usual Vocational Rehabilitation, TAU-VR). Veterans who may be suitable candidates have been diagnosed with opioid use disorder, are currently unemployed or working less than 20 hours a week in a meaningful job, and are interested in finding competitive employment. As an unphased trial, this study offers Veterans the chance to contribute to research that could improve employment support services.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on employment support rather than medication changes.

What prior data suggests that these vocational rehabilitation methods are safe for Veterans with opioid use disorder?

Research has shown that Individual Placement and Support (IPS) effectively helps people find and keep jobs, particularly those recovering from substance use problems. IPS emphasizes securing regular community jobs that match individuals' interests and skills.

No evidence suggests IPS is unsafe. Many studies have demonstrated its ability to help people find jobs without causing harm. It is considered safe because it primarily involves job coaching and support, not medication or medical procedures. As a result, most participants find IPS manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Individual Placement and Support (IPS) for treating opioid use disorder because it offers a personalized approach to vocational rehabilitation. Unlike traditional methods that focus on transitional, low-wage jobs with limited support, IPS emphasizes rapid job searches in competitive employment sectors, integrating job placement with personalized treatment and counseling. The IPS model provides ongoing, individualized support, differentiating it from standard care options that often have a fixed duration. This approach could significantly improve long-term job retention and recovery outcomes for individuals with opioid use disorder.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that Individual Placement and Support (IPS), one of the treatment options in this trial, effectively helps people with substance use problems, such as opioid addiction, find jobs. Studies have found that IPS enables more people to secure regular employment compared to other methods. Specifically, one study found that individuals using IPS were more successful in finding work than those who did not use it. This approach emphasizes quickly obtaining a job and providing personalized support, which has proven helpful for many. Strong evidence supports IPS as an effective method for those dealing with addiction, making it a promising option for increasing employment. Another treatment arm in this trial, Treatment As Usual Vocational Rehabilitation (TAU-VR), will be compared to IPS to evaluate its effectiveness in supporting employment for individuals with opioid use disorder. ^{2 6 7 8 9}

Who Is on the Research Team?

Mercy N Mumba, RN

Principal Investigator

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Are You a Good Fit for This Trial?

This trial is for Veterans aged 19 or older with opioid use disorder who are unemployed or underemployed, working less than 20 hours a week. They must want to work and be able to consent to the study. Those with severe medical conditions, active suicidal thoughts, involvement in other vocational trials, psychotic disorders, dementia, or anticipated inability to complete the study cannot participate.

Inclusion Criteria

I am 19 years old or older.

Expression of interest in competitive employment; and willing and able to give informed consent

DSM-5 Axis I diagnosis of OUD

Exclusion Criteria

Active suicidal or homicidal ideation making it unsafe for Veteran to be included

Current participation in another vocational interventional trial

Presence of current severe and unstable medical condition or terminal illness, that would contraindicate study participation or expose them to an undue risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Individual Placement and Support (IPS) or Treatment-as-Usual Vocational Rehabilitation (TAU-VR) services to improve employment outcomes

15 months

Follow-up

Participants are monitored for employment outcomes, quality of life, social support, depression, anxiety, resilience, and suicide risk

15 months

What Are the Treatments Tested in This Trial?

Interventions

• Individual Placement and Support (IPS)
• Treatment As Usual Vocational Rehabilitation (TAU-VR)

Trial Overview The trial aims to assist Veterans with opioid problems by comparing two employment support methods: Treatment As Usual Vocational Rehabilitation (TAU-VR) and Individual Placement and Support (IPS). It will evaluate how these approaches affect their ability to find and keep jobs as well as improve overall wellbeing.

How Is the Trial Designed?

Group I: Individual Placement and Support Experimental Treatment 1 Intervention

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.

Group II: Treatment As Usual Vocational Rehabilitation (TAU-VR) Active Control 1 Intervention

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) is already approved in United States, European Union for the following indications:

Approved in United States as IPS Supported Employment for:

• Serious Mental Illness
• Co-occurring Substance Use Disorders
• Veterans with Opioid Use Problems

Approved in European Union as Individual Placement and Support for:

• Serious Mental Illness
• Co-occurring Substance Use Disorders

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The systematic review identified 14 studies focused on improving employment outcomes for individuals with substance use disorder, with Individual Placement and Support (IPS) and Customized Employment Supports (CES) showing the most positive results.

Despite some positive findings, the overall impact of interventions on employment outcomes was small, highlighting the need for further research with larger sample sizes and consistent outcome measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Interventions Intended to Improve Employment Outcomes for Persons with Substance Use Disorder: An Updated Systematic Review. Magura, S., Marshall, T.[2021]

The Individual Placement and Support (IPS) model significantly outperformed conventional vocational rehabilitation programs, achieving a cumulative employment rate of 60% compared to 24% for the control group over an 18-month follow-up period.

Clients receiving IPS not only secured jobs more quickly but were also more likely to work 20 or more hours per week, indicating better overall competitive work outcomes for individuals with severe mental illness and co-occurring substance use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Supported Employment in People With Dual Disorders. Mueser, KT., Campbell, K., Drake, RE.[2021]

The IPS-AD study is a large-scale, randomized controlled trial involving 832 participants to evaluate the effectiveness of Individual Placement and Support (IPS) for individuals with alcohol and drug dependence, aiming to improve their competitive employment status over an 18-month follow-up period.

This study is significant as it is the first to rigorously test IPS in this population, potentially leading to improved employment outcomes and better service delivery for those struggling with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence. Marsden, J., Anders, P., Clark, H., et al.[2020]

In a study of 91 adults undergoing treatment for opioid use disorder, 42.9% found employment, with higher success linked to more days worked in a therapeutic workplace and more drug-free urine samples during the job search.

Participants who had shorter histories of unemployment were more likely to secure jobs, suggesting that addressing attendance and drug abstinence in treatment could enhance employment outcomes for those in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with obtaining employment among opioid use disorder patients enrolled in a therapeutic workplace intervention. Holtyn, AF., Toegel, F., Novak, MD., et al.[2022]

In a study of 45 patients with opioid use disorders receiving methadone maintenance therapy, those who participated in the Individual Placement and Support (IPS) program had significantly higher rates of gaining competitive employment (50%) compared to those on a waitlist (5%) during the first 6 months.

After 12 months, 50% of IPS participants were employed compared to 22% of the waitlist group, suggesting that IPS is a promising employment intervention for individuals in opioid treatment programs, although further research with larger samples is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Placement and Support (IPS) for Methadone Maintenance Therapy Patients: A Pilot Randomized Controlled Trial. Lones, CE., Bond, GR., McGovern, MP., et al.[2017]

Individual Placement and Support (IPS) has strong evidence supporting its effectiveness for adults with Substance Use Disorders (SUD), both alone and in combination with mental health disorders, based on a systematic review of studies from 2000 to 2019.

Key components of IPS, such as zero exclusion and rapid job placement, make it a valuable approach for integrating work into recovery, despite challenges like treatment episodicity and risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Individual Placement and Support Employment Intervention for Persons with Substance Use Disorder. Harrison, J., Krieger, MJ., Johnson, HA.[2021]

The pilot study involving eight chronic pain patients showed that the Individual Placement and Support (IPS) model was well-received, with participants reporting positive experiences and no adverse effects from the intervention.

Three out of the eight participants gained competitive employment within 12 months, indicating that IPS can be effectively integrated into pain rehabilitation programs and should be further tested in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the individual placement and support model for patients with chronic pain. Rødevand, L., Ljosaa, TM., Granan, LP., et al.[2018]

The Motivated Stepped Care (MSC) intervention effectively increased employment rates among opioid-dependent patients, with 93% of those capable of working being employed after one year of treatment.

Employment was linked to better drug use outcomes, as patients who found jobs experienced less frequent need for intensive counseling and showed improvements in work stability and functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining stepped-care approaches with behavioral reinforcement to motivate employment in opioid-dependent outpatients. Kidorf, M., Neufeld, K., Brooner, RK.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10967214/

Individual Placement and Support for persons with alcohol ... The aim of the present IPS for Alcohol and Drug Addiction in Sweden (IPS-ADAS) trial is to study whether IPS has an effect on gaining employment for this group.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023005771

Superiority and cost-effectiveness of Individual Placement ... In this first superiority randomised controlled trial of IPS in alcohol and drug dependence, IPS helped more people attain employment in the open competitive ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05673-z

study protocol for a randomized controlled trial of IPS versus ... The aim of the IPS for substance use disorders (IPS-SUD) trial is to investigate the effect of IPS in a SUD population.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70155

The effectiveness of Individual Placement and Support on ... Individual Placement and Support (IPS) has proven effective in helping patients with psychosis obtain competitive employment. We aimed to ...

5. clear.dol.gov clear.dol.gov/Study/Individual-placement-and-support-IPS-methadone-maintenance-therapy-patients-pilot-randomized

A pilot randomized controlled trial (Lones et al., 2017) | CLEAR The study's objective was to examine the impact of Individual Placement and Support (IPS) on employment. The study was a randomized control trial that ...

6. library.samhsa.gov library.samhsa.gov/product/individual-placement-and-support-ips-supported-employment-model/pep25-01-002

Individual Placement and Support (IPS) The IPS model of Supported Employment is grounded in research showing the transformative power of employment as a path to recovery.

7. dol.gov dol.gov/node/161380

TEN_2-21.pdf Drake spoke on how Job Centers can successfully place individuals with substance use disorders SUD in employment through Individual Placement and Support IPS .

8. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00577-1/fulltext

Superiority and cost-effectiveness of Individual Placement ... IPS was cost-effective for QALY health outcome at a £70,000 willingness-to-pay threshold, and £200 willingness-to-pay threshold per additional ...

9. mn.gov mn.gov/dhs/partners-and-providers/policies-procedures/adult-mental-health/individual-placement-and-support-services/index.jsp

Individual Placement and Support Services ... - Minnesota.gov The efficacy and effectiveness of IPS has been empirically validated in achieving competitive employment outcomes for people in recovery from a ...