What side effects are associated with this type of intervention?

The most common treatments for Opioid Use Disorder (OUD) include methadone and buprenorphine. Methadone can cause side effects such as constipation, nausea, vomiting, drowsiness, and respiratory depression. Buprenorphine, which is often used in combination with naloxone, can also cause similar side effects, including constipation, headache, nausea, and sweating. Both medications carry a risk of dependency and should be monitored closely by healthcare providers. Additionally, these treatments can interact with other central nervous system depressants, increasing the risk of overdose. Employment support programs may help improve adherence to these treatments and overall well-being.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. Methadone is a long-acting opioid agonist that reduces withdrawal symptoms and cravings. Buprenorphine, available in sublingual and buccal formulations, is a partial opioid agonist that also helps manage withdrawal and cravings with a lower risk of misuse. Naltrexone is an opioid antagonist that blocks the effects of opioids and is available in oral and extended-release injectable forms. These medications, often combined with psychosocial support and counseling, are effective in improving treatment adherence and overall well-being, which aligns with the goals of employment support programs for veterans.

What other types of research exist?

Promising alternatives to Employment Support for OUD patients include: 1) Contingency Management, which uses positive reinforcement to encourage treatment adherence; 2) Assertive Community Treatment (ACT) with integrated illness management and recovery programs to reduce hospitalizations and improve mental health outcomes; 3) Managed Opioid Programs that pair injectable opioid agonist treatments with supportive housing to enhance retention and social well-being; and 4) Rapid Transition Protocols from methadone to buprenorphine using micro-dosing to reduce barriers to adherence.

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Vocational Rehabilitation for Opioid Use Disorder (THRIVE Trial)

Q: What is the mechanism of action of this treatment?

Methadone and buprenorphine are opioid agonists that work by binding to the same receptors in the brain as opioids, reducing cravings and withdrawal symptoms without producing the same high, thus helping patients stabilize and engage in recovery activities. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing the euphoric and sedative effects, which helps in preventing relapse. Cognitive-behavioral therapy (CBT) helps patients identify and change negative thought patterns and behaviors related to substance use, while contingency management uses positive reinforcement to encourage abstinence and treatment adherence. These treatments are crucial for OUD patients as they address both the physiological and psychological aspects of addiction, improving the chances of sustained recovery and overall well-being, especially when combined with structured support like employment programs.

N/A

Recruiting

Led By Mercy N Mumba, RN

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 19* (<19 year of age in the state of AL is defined minor)

Currently unemployed or underemployed, defined as working <20hrs/week in a meaningful competitive job for a wage, salary, or commission

Must not have

Diagnosis of dementia (evidenced in the medical record)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on employment support rather than medication, it does not have typical 'side effects.' However, participants may experience stress or anxiety related to job searching and maintaining employment during the course of the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 19 years old or older.

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I am currently working less than 20 hours a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My medical records show a diagnosis of dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

number of weeks worked

Secondary study objectives

Anxiety

Depression

Quality of Life

+2 more

Other study objectives

suicide risk

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Individual Placement and SupportExperimental Treatment1 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 Control1 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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Methadone and buprenorphine are opioid agonists that work by binding to the same receptors in the brain as opioids, reducing cravings and withdrawal symptoms without producing the same high, thus helping patients stabilize and engage in recovery activities. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing the euphoric and sedative effects, which helps in preventing relapse. Cognitive-behavioral therapy (CBT) helps patients identify and change negative thought patterns and behaviors related to substance use, while contingency management uses positive reinforcement to encourage abstinence and treatment adherence. These treatments are crucial for OUD patients as they address both the physiological and psychological aspects of addiction, improving the chances of sustained recovery and overall well-being, especially when combined with structured support like employment programs.

Systematic review on the clinical management of chronic pain and comorbid opioid use disorder.