A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment

NCT05189223 | Recruiting

• 2 other identifiers: D3789-WIK2RX003789
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Community integration; Veterans; Buprenorphine

Outcome Measures

Primary Outcomes (6)

• Expectancy item of the Credibility/Expectancy Questionnaire (CEQ)

  The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure which will be administered following the first intervention session. Expectancy will be measured using item 4, the most common index for expectancy. This item is rated on a scale from 0% to 100% with higher percentages reflecting higher anticipated improvement. As an indicator of acceptability of the intervention in Phase 3, the investigators will use a priori benchmark of average expectancy at or above 50%. improvement expected.

  1 week

• Number of participants recruited

  Feasibility will be assessed in Phase 3 using an a priori benchmark of at least n=2 participants recruited on average per month.

  Through study completion, up to three years

• Client Satisfaction Questionnaire 8-item (CSQ-8)

  The Client Satisfaction Questionnaire 8-item (CSQ-8) is a commonly used 8-item measure which has been used with similar participant samples to assess treatment satisfaction. Scores range from 8 to 32, with higher scores reflecting higher satisfaction. It will be used in Phase 3 as an additional measure of acceptability for the intervention, using an a priori benchmark of average satisfaction scores at or above 24.

  6 weeks

• Number of treatment sessions attended

  Feasibility will be assessed in Phase 3 using an a priori benchmark of at least 3 of the 4 sessions attended by 50% or more of the study participants. The six week time frame provides some flexibility for scheduling the 4 weekly study sessions.

  6 weeks

• Therapist Adherence

  Therapist adherence and competence scales will be developed in Phase 2 and used to assess Therapist Adherence to the treatment as a feasibility measure using an a priori benchmark of 80%. The scale will be adapted from a rating system designed to assess use of broadly defined ACT-consistent therapeutic strategies, appropriate use of specific ACT techniques from a given manual, and the absence of techniques that are inconsistent with ACT-based interventions. The structure of the overall scale will be retained, such that each item is assessed for frequency and extensiveness on a scale of 1 (not at all) to 5 (extensively).

  6 weeks

• Credibility subscale of the Credibility/Expectancy Questionnaire (CEQ)

  The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure which will be administered following the first intervention session. The three item Credibility subscale produces scores ranging from 3 to 27, with higher scores reflecting higher credibility. As an indicator of acceptability of the intervention in Phase 3, the investigators will use an a priori benchmark of average credibility at or above 15, reflecting a "somewhat" credible rating.

  1 Week

Secondary Outcomes (5)

• Change in the Social Adjustment Scale-Self Report

  Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up

• Change in the Medical Outcomes Study (MOS) Social Support Survey

  Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up

• Change in days of opioid use on the Addiction Severity Index-Lite

  Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up

• Change in the World Health Organization Quality Of Life (WHOQOL)-BREF

  Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up

• Change in medication (buprenorphine, methadone, or naltrexone) appointment attendance

  Baseline, End of Treatment (6 weeks), 3-month follow-up, and 6-month follow-up

Study Arms (3)

Open Pilot

OTHER

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

Behavioral: Brief, values based intervention for early buprenorphine treatment

Active Condition

EXPERIMENTAL

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

Behavioral: Brief, values based intervention for early buprenorphine treatment

Treatment as Usual

ACTIVE COMPARATOR

In Phase 3 (Pilot RCT), half of Veterans will be randomly assigned to treatment as usual.

Behavioral: Treatment as Usual

Interventions

Brief, values based intervention for early buprenorphine treatment BEHAVIORAL

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.

Active Condition; Open Pilot

Treatment as Usual BEHAVIORAL

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.

Also known as: Medication Management

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics; Medication Therapy Management

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Study Officials

• Victoria Ameral, PhD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Ameral, PhD

CONTACT

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

Anne Marie Hernon

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In Phase 3, assessment sessions will be conducted by an independent assessor who is blind to study assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants in Phase 2 will all receive the treatment. Participants in Phase 3 will be randomly assigned to the 4-session study treatment or treatment as usual.

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: September 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)