What is buprenorphine studying for opioid use disorder?

Buprenorphine is being studied to compare a monthly injectable form against the daily oral form to see which better helps Veterans stay in treatment and avoid opioid use. The study aims to improve opioid disorder care and is sponsored by the VA Office of Research and Development. Participants can expect close monitoring over one year with long-term follow-up afterwards.

Who may be eligible for this opioid use disorder clinical trial?

Adults aged 18 or older diagnosed with moderate to severe opioid use disorder who have recently used opioids or entered supervised care may be eligible. Participants must be starting treatment with sublingual buprenorphine and willing to accept partial-agonist therapy. The trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this opioid use disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID04375033

Comparative Effectiveness of Injectable Versus Daily Oral Buprenorphine for Opioid Use Disorder Treatment in Veterans VA-BRAVE

Led by VA Office of Research and Development · Updated on 2026-01-12

952

Participants Needed

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a long-acting injectable form of buprenorphine compared to the daily sublingual under the tongue buprenorphine in treating Veterans with moderate to severe opioid use disorder OUD. This open-label, randomized controlled trial aims to see which treatment better retains Veterans in opioid therapy and helps sustain opioid abstinence. The study also examines secondary outcomes such as substance use, overdose incidents, infectious disease testing, psychiatric symptoms, housing status, dental health, and cost-effectiveness. Participants are Veterans aged 18 and older diagnosed with moderate to severe OUD and beginning a new treatment episode. After an induction period on daily sublingual buprenorphine, participants are randomly assigned to receive either a 28-day supply of daily sublingual buprenorphine or a monthly injectable buprenorphine shot administered in the clinic. Doses for the injectable form target 300mg, with a 100mg option for those who cannot tolerate the higher dose. Study visits occur weekly during the first month, then every two weeks until week 52, including medication management. Throughout the 52-week active phase, participants report opioid use and provide urine samples every two weeks to evaluate abstinence and treatment retention. Additional assessments include HIV, Hepatitis B and C testing, psychiatric questionnaires, risk behavior evaluations, and dental health surveys. After the active phase, participants are followed passively using medical records for up to 10 years to monitor long-term outcomes. The study expects to recruit 952 Veterans over 7 years across multiple VA Medical Centers.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Has used opioids within 30 days prior to consent or prior to entry into a supervised setting
Have started or are in the process of starting medication treatment with sublingual buprenorphine with naloxone
Meets DSM-5 criteria for moderate to severe opioid use disorder
Referred to or seeking treatment for opioid use disorder and willing to accept partial-agonist-based therapy
Aged 18 years or older

You will not qualify if you...

Is a Veteran younger than 18 years
Pregnancy, breastfeeding, or not using effective birth control for those of childbearing potential
Failure to reach maintenance dose of 4mg to 32mg sublingual buprenorphine with naloxone within 45 days
Taking maintenance medication for opioid use disorder continuously for more than 45 days prior to randomization
History of significant adverse effects from buprenorphine or naloxone
Recent suicidal or homicidal ideation requiring acute treatment or hospitalization
Unwilling or unable to provide consent
Current severe sedative hypnotic use disorder
Anuria or dialysis
Moderate to severe COVID-19 symptoms with risk of critical illness
Medical, psychiatric, behavioral, or logistical conditions preventing participation or completion of the 52-week study
Actively enrolled in another interventional clinical trial without waiver of dual enrollment

Research Team

Avron Spiro, PhD MS

Melynn Nuite, RN BS CCRC

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here