A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment

Recruiting now · Not applicable

Conditions studied: Dependence, Opioid

In brief

The US Veteran community continues to feel the impact of the overdose crisis, and opioid use disorder (OUD) diagnoses among Veterans continue to rise. Medication treatment (e.g., buprenorphine, methadone, naltrexone) helps prevent relapse and reduce overdose risk, but does not help with the psychological, social, and functional challenges of early recovery. Therapies that focus on interpersonal functioning and community integration may help improve quality of life during this high-risk period. This research project will create and test a brief, values-based treatment to help Veterans improve their interpersonal functioning and community integration during early treatment. This study will have three phases. Phase 1 will involve the development of the treatment and adaptation using interviews with Veterans and VA Providers. Phase 2 will test the treatment with a group of 10 Veterans to make sure the treatment can be delivered as intended, and to make changes to the treatment or study procedures based on Veteran feedback. Finally, Phase 3 will test the treatment compared to usual treatment in a pilot randomized controlled trial with a group of 40 Veterans. This final phase will provide additional information about Veterans' experience of the treatment and study procedures and the preliminary effects of the treatment on quality of life and related outcomes.

Key facts

Study ID

NCT05189223

Run by

VA Office of Research and Development

People needed

50

Starts

2023-09-01

Expected to finish

2027-03-31

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets current Diagnostic and Statistical Manual - 5th Edition criteria for moderate to severe opioid use disorder
• Phase 2: Within 12 weeks of initiating buprenorphine, methadone, or naltrexone treatment for opioid use disorder following at least 2 months without treatment; Phase 3: Within 12 weeks of initiating buprenorphine, methadone, or naltrexone treatment for opioid use disorder following at least 2 months without treatment
• Competent to provide written informed consent

You may not qualify if…

• Evidence of active psychosis or mania
• Suicidality requiring inpatient hospitalization
• Active substance use requiring detoxification
• Cognitive impairment that would interfere with study participation

Where it is running

• VA Bedford HealthCare System, Bedford, MA — Bedford, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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