Actively Recruiting
A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment
Led by VA Office of Research and Development ยท Updated on 2025-07-17
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to develop and test a brief, values-based treatment to support US Veterans with opioid use disorder (OUD) during early medication treatment. The study focuses on improving interpersonal functioning and community integration to enhance quality of life during the high-risk early recovery period. It will proceed in three phases: treatment development and adaptation, an open pilot with 10 Veterans, and a pilot randomized controlled trial comparing the new treatment to usual care with 40 Veterans. In Phase 1, the treatment manual is developed and revised using interviews with Veterans and VA providers. Phase 2 involves delivering the intervention in four weekly 50-minute sessions to 10 Veterans receiving buprenorphine, refining the manual and study procedures based on feedback. Phase 3 randomizes 40 Veterans to either the new intervention or treatment as usual, with the intervention delivered by trained clinical psychology fellows and usual care including case management and group therapy. Participants will attend assessments at baseline, post-treatment (6 weeks), and follow-ups at 3 and 6 months. Assessments include measures of interpersonal functioning, community reintegration, quality of life, substance use, and treatment adherence. Sessions and assessments may be in-person or remote, with independent evaluators conducting assessments. Therapist adherence and competence will be monitored. The study will track treatment attendance, participant satisfaction, and feasibility outcomes over approximately six months per participant.
CONDITIONS
Brief Title
A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Evidence of active psychosis or mania
- Suicidality requiring inpatient hospitalization
- Active substance use requiring detoxification
- Cognitive impairment that would interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive weekly behavioral intervention sessions designed to improve interpersonal functioning and community reintegration during early medication treatment for opioid use disorder. The intervention consists of four 50-minute sessions focused on values clarification, managing treatment challenges, goal setting, and recovery planning.
Weekly visits for up to 4 weeks and assessment visits at baseline, post-treatment, 3-month, and 6-month follow-up
Duration - 6 months
Participants complete follow-up assessments to evaluate changes in social adjustment, quality of life, substance use, and treatment adherence up to 6 months after treatment completion.
3 visits (at post-treatment, 3-month, and 6-month follow-up)
Trial Site Locations
Total: 1 location
1
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, United States, 01730-1114
Actively Recruiting
Research Team
V
Victoria Ameral, PhD
A
Anne Marie Hernon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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