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Opioid Partial Agonist

Buprenorphine Forms for Opioid Use Disorder (VA-BRAVE Trial)

Phase 4

Recruiting

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy

Referred to/seeking treatment for OUD and willing to accept 'partial-agonist-based' therapy

Must not have

Is a Veteran less than 18 years of age

Has a history of significant adverse effects from buprenorphine and/or naloxone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, week 24, week 52 (active phase) and via emr review for up to 10 years (passive phase)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial will compare two different ways of taking buprenorphine to see if one is better than the other at helping people with opioid addiction.

Who is the study for?

This trial is for Veterans with moderate to severe opioid use disorder who have used opioids within the last 30 days. They must be seeking treatment and open to 'partial-agonist-based' therapy. Exclusions include inability to consent, pending felony charges, certain medical or psychiatric conditions, recent suicidal ideation requiring hospitalization, and those already on medication-assisted treatment for over a month.

What is being tested?

The study compares two forms of buprenorphine: a monthly injectable dose (300mg) versus daily sublingual doses (16-24mg). It aims to see which is better at keeping patients in treatment and abstinent from opioids over a year-long period among 952 Veteran participants.

What are the potential side effects?

Possible side effects of buprenorphine can include nausea, vomiting, drug withdrawal syndrome, constipation, headaches, sweating, sleeping difficulties, and pain at the injection site for the injectable form.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am seeking treatment for opioid use disorder and open to partial-agonist therapy.

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I am seeking treatment for opioid use disorder and open to partial-agonist therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a Veteran and under 18 years old.

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I have had severe side effects from buprenorphine or naloxone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, week 24, week 52 (active phase) and via emr review for up to 10 years (passive phase)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, week 24, week 52 (active phase) and via emr review for up to 10 years (passive phase)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, week 24, week 52 (active phase) and via emr review for up to 10 years (passive phase) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid Abstinence

Retention in Treatment Change

Secondary study objectives

Accidental Opioid Poisoning (overdose)

Dental Quality of Life Questionnaire

HIV Sexual and Injection Risk Behaviors

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sublingual ArmExperimental Treatment1 Intervention

The sublingual buprenorphine contains naloxone in a ratio of 4:1 and will be prescribed. Consistent with the SAMHSA TIP 40 guidelines 75, before SL-BUP/NLX is prescribed, participants will be evaluated for recent (within 24 hours) drug use and associated symptoms. The randomization dose will be determined based on the maintenance dose identified during the induction period, with a target dose of 16-32mg that is standard practice. While the target dose is 16-32mg, doses may go as low as 8mg as occasionally patients prefer lower doses. SL-BUP/NLX will be prescribed at the randomization visit (28-day supply), then every 4 weeks until week 48.

Group II: Injectable ArmExperimental Treatment1 Intervention

Injectable buprenorphine consists of a depot injectable formulation in polymeric solution and releases buprenorphine over a 28-day (4-week) period by diffusion as the polymer biodegrades. The injection will be administered subcutaneously in the abdomen at each 28-day visit. The target dose is 300mg, there is the option to use 100mg dose. The final study dose of injectable buprenorphine will be given at Week 48.

0 / 4Eligibility criteria met