A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment
VA Office of Research and Development
50 participants
Sep 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Meets current Diagnostic and Statistical Manual - 5th Edition criteria for moderate to severe opioid use disorder
- 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
Exclusion Criteria4
- Evidence of active psychosis or mania
- Suicidality requiring inpatient hospitalization
- Active substance use requiring detoxification
- Cognitive impairment that would interfere with study participation
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The initial intervention structure consists of four weekly sessions. Session one focuses on values clarification using an empirically validated clinical exercise. The second session will include a discussion of the connection between values, addiction treatment engagement, and the challenges associated with discomfort (i.e., withdrawal and cravings) in early treatment. The third session will focus on barriers and goal setting to enhance self-efficacy for committed action. The final session will review progress made and focus on the Veterans' recovery plan moving forward. The initial study intervention will be refined iteratively using Phase 1 stakeholder and Phase 2 open trial participant feedback.
Veterans will be recruited from an intensive treatment phase where all Veterans receive case management and regular group therapy in addition to appointments with their buprenorphine, methadone, or naltrexone prescriber. After the first two weeks, they have the option to continue with a less intensive group schedule and case management support through an Aftercare program.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05189223