A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment

NCT05189223 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

  • Dependence, Opioid

Interventions

BEHAVIORAL

Brief, values based intervention for early buprenorphine treatment

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.

BEHAVIORAL

Treatment as Usual

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Victoria Ameral, PhD · VA Bedford HealthCare System, Bedford, MA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05189223 on ClinicalTrials.gov