RECRUITING

A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment

Quick Facts

Study Start:2023-09-01
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05189223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets current Diagnostic and Statistical Manual - 5th Edition criteria for moderate to severe opioid use disorder
  2. * Within 12 weeks of initiating buprenorphine, methadone, or naltrexone treatment for opioid use disorder following at least 2 months without treatment
  3. * Competent to provide written informed consent
  1. * Evidence of active psychosis or mania
  2. * Suicidality requiring inpatient hospitalization
  3. * Active substance use requiring detoxification
  4. * Cognitive impairment that would interfere with study participation

Contacts and Locations

Study Contact

Victoria Ameral, PhD
CONTACT
(781) 687-3015
Victoria.Ameral@va.gov
Anne Marie Hernon
CONTACT
(781) 687-2903
annemarie.hernon@va.gov

Principal Investigator

Victoria Ameral, PhD
PRINCIPAL_INVESTIGATOR
VA Bedford HealthCare System, Bedford, MA

Study Locations (Sites)

VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Community integration
  • Veterans
  • Buprenorphine

Additional Relevant MeSH Terms

  • Dependence, Opioid