RECRUITING

A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder

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

VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous (in the belly area) formulation of buprenorphine at a target dose of 300mg is superior in retaining Veterans in opioid treatment and in sustaining opioid abstinence compared to the daily sublingual (under the tongue) buprenorphine formulation at a target dose of 16-32 mg (standard of care). This is an open-label, randomized, controlled trial including 952 Veterans with opioid use disorder (OUD) recruited over 7 years and followed actively for 52 weeks. There are a number of secondary objectives that will be studied as well and include: comorbid substance use, both non-fatal and fatal opioid overdose, HIV and Hepatitis B (HBV) and C (HCV) testing results and risk behaviors, incarceration, quality of life, psychiatric symptoms of depression and posttraumatic stress disorder, housing status, dental health and utilization, and cost-effectiveness.

Official Title

CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE)

Quick Facts

Study Start:2020-11-03
Study Completion:2029-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04375033

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. * Has used opioids within 30 days prior to consent or within 30 days prior to entry into a supervised setting -- e.g., opioid use within the 30 days prior to recent (\<30 days) incarceration, entry into a detoxification facility, or entry into an inpatient hospital setting
  2. * Have started on MOUD via clinical induction on SL-BUP/NLX
  3. * Meets DSM-5 criteria for moderate to severe OUD based on the Mini-International Neuropsychiatric Interview
  4. * Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy
  1. * Is a Veteran less than 18 years of age
  2. * For Veterans of childbearing potential (a premenopausal person capable of becoming pregnant), pregnancy, breastfeeding, and/or failure to practice an effective method of birth control
  3. * Failure to reach maintenance dose of 8mg - 32mg SL-BUP/NLX in 45 days or less (must have taken 3 consecutive days of maintenance dose immediately before randomization).
  4. * Taking a form of prescribed maintenance MOUD (e.g., methadone, buprenorphine or XR-NTX) continuously \>45 days prior to randomization
  5. * Has a history of significant adverse effects from buprenorphine and/or naloxone
  6. * Has experienced (within the past 2 weeks) recent suicidal or homicidal ideation that requires acute treatment or hospitalization.
  7. * Is unwilling or unable to provide consent
  8. * Meets criteria for current (past month) DSM-5 severe sedative hypnotic use disorder based on the MINI SHUD module
  9. * Anuria and/or dialysis
  10. * Current moderate to severe COVID-19 symptoms with a risk of intubation or critical illness.
  11. * Medical, psychiatric, behavioral, or logistical condition which, in the judgement of the Local Site Investigator (LSI) or Co-Investigator (Co-I), requires a higher level of acute care and/or makes it unlikely the patient can participate in or complete the 52-week active phase of the study.
  12. * Is actively participating in an interventional clinical trial for which a waiver of dual-enrollment with CSP #2014 has not been obtained.

Contacts and Locations

Study Contact

Avron Spiro, PhD MS
CONTACT
(857) 364-2888
avron.spiro@va.gov
Melynn Nuite, RN BS CCRC
CONTACT
(617) 232-9500
Melynn.Nuite@va.gov

Principal Investigator

Ismene L. Petrakis, MD
STUDY_CHAIR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Sandra Ann Springer, MD
STUDY_CHAIR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Locations (Sites)

Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404-5015
United States
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
United States
CERC (VISN1, West Haven, CT)
West Haven, Connecticut, 06516-2770
United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
United States
Wilmington VA Medical Center, Wilmington, DE
Wilmington, Delaware, 19805-4917
United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, 33744-0000
United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
United States
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, 45428
United States
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19106
United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
United States
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
United States
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05001-3833
United States
Hampton VA Medical Center, Hampton, VA
Hampton, Virginia, 23667
United States
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153-6404
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States
Huntington VA Medical Center, Huntington, WV
Huntington, West Virginia, 25704-9300
United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-0001
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Ismene L. Petrakis, MD, STUDY_CHAIR, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Sandra Ann Springer, MD, STUDY_CHAIR, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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 Date2020-11-03
Study Completion Date2029-05-31

Study Record Updates

Study Start Date2020-11-03
Study Completion Date2029-05-31

Terms related to this study

Keywords Provided by Researchers

  • Buprenorphine
  • Veterans
  • Clinical Trial
  • Opioid Abstinence
  • Retention in Care
  • Pharmacotherapy

Additional Relevant MeSH Terms

  • Opioid Use Disorder