Vocational Rehabilitation for Opioid Use Disorder

(THRIVE Trial)

Recruiting at1 trial location

Overseen by Mercy N Mumba, RN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial compares two job support programs for Veterans recovering from opioid addiction to see which helps them work longer in competitive jobs. It also examines how job support affects their medication adherence, mental health, and social integration.

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 data supports the effectiveness of the treatment Individual Placement and Support (IPS) for opioid use disorder?

Research shows that Individual Placement and Support (IPS) can help people with opioid use disorder find jobs. In a study, 50% of participants using IPS found employment compared to only 5% in a control group, suggesting IPS is promising for improving job outcomes in this group. ^{1 2 3 4 5}

Is Individual Placement and Support (IPS) safe for people with opioid use disorder?

The available research does not report any specific safety concerns related to the use of Individual Placement and Support (IPS) for people with opioid use disorder. IPS is generally considered a safe employment support intervention, as it has been widely used for individuals with severe mental illness and other conditions without noted safety issues. ^{1 2 3 5 6}

How is the Individual Placement and Support (IPS) treatment different for opioid use disorder?

The Individual Placement and Support (IPS) treatment is unique because it focuses on helping people with opioid use disorder find and keep competitive jobs as part of their recovery process. Unlike traditional treatments that primarily address medical or psychological aspects, IPS integrates employment support directly into the treatment plan, emphasizing rapid job search and ongoing support. ^{1 5 6 7 8}

Research Team

Mercy N Mumba, RN

Principal Investigator

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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 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]

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 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]

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]

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 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]

References

1. England 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Individual Placement and Support (IPS) for Methadone Maintenance Therapy Patients: A Pilot Randomized Controlled Trial. [2017]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Combining stepped-care approaches with behavioral reinforcement to motivate employment in opioid-dependent outpatients. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Factors associated with obtaining employment among opioid use disorder patients enrolled in a therapeutic workplace intervention. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Review of Individual Placement and Support Employment Intervention for Persons with Substance Use Disorder. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A pilot study of the individual placement and support model for patients with chronic pain. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Supported Employment in People With Dual Disorders. [2021]