Recruiting

Buprenorphine

Sponsor:

VA Office of Research and Development

Code:

NCT05189223

Conditions

Dependence, Opioid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brief, values based intervention for early buprenorphine treatment

Study Details

Brief 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

Study ID

NCT05189223

Start date

Sep 1, 2023

Status verified date

Jun, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Open Pilot

In Phase 2, all Veterans will receive the active treatment.

experimental: Active Condition

In Phase 3 (Pilot RCT), all Veterans will be assigned to the active treatment.

Interventions

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.

Primary outcome measure

  • Expectancy item of the Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: 1 week ]
  • Number of participants recruited [ Time Frame: Through study completion, up to three years ]
  • Client Satisfaction Questionnaire 8-item (CSQ-8) [ Time Frame: 6 weeks ]
  • Number of treatment sessions attended [ Time Frame: 6 weeks ]
  • Therapist Adherence [ Time Frame: 6 weeks ]
  • Credibility subscale of the Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: 1 Week ]

Central Contacts and Locations

Central contacts

Victoria Ameral, PhD

(781) 687-3015Victoria.Ameral@va.gov

Anne Marie Hernon

(781) 687-2903annemarie.hernon@va.gov

Locations

VA Bedford HealthCare System, Bedford, MA

Recruiting

Bedford, Massachusetts, United States, 01730-1114

Contacts

Victoria Ameral, PhD

(781) 687-3015Victoria.Ameral@va.gov

Principal Investigator:

Victoria Ameral, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Community integration
  • Veterans
  • Buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-23.