NCT05388812

Brief 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 of society.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Dec 2022Sep 2027

First Submitted

Initial submission to the registry

May 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 16, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

May 19, 2022

Last Update Submit

March 16, 2026

Conditions

Keywords

Veteranopioid use disorderemploymentsocial supportmental health

Outcome Measures

Primary Outcomes (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

    15 months

Secondary Outcomes (5)

  • Quality of Life

    15 months

  • social support

    15 months

  • Depression

    15 months

  • Anxiety

    15 months

  • Resilience

    15 months

Other Outcomes (1)

  • suicide risk

    15-months

Study Arms (2)

Individual Placement and Support

EXPERIMENTAL

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.

Other: Individual Placement and Support (IPS)

Treatment As Usual Vocational Rehabilitation (TAU-VR)

ACTIVE COMPARATOR

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

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

Interventions

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.

Individual Placement and Support

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

Treatment As Usual Vocational Rehabilitation (TAU-VR)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927, United States

Location

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404-5015, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersPsychological Well-Being

Interventions

TherapeuticsPalliative Care

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Patient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mercy N Mumba, RN

    Tuscaloosa VA Medical Center, Tuscaloosa, AL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: eligible and consenting participants will be randomized to either individual placement and support (IPS) or treatment as usual vocational rehabilitation (TAU-VR).
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 24, 2022

Study Start

December 16, 2022

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations