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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
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
VA-BRAVE Trial 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.Check my eligibility
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.See study design
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.
VA-BRAVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am seeking treatment for opioid use disorder and open to partial-agonist therapy.
Select...
I am seeking treatment for opioid use disorder and open to partial-agonist therapy.
VA-BRAVE Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid Abstinence
Retention in Treatment Change
Secondary outcome measures
Accidental Opioid Poisoning (overdose)
Dental Quality of Life Questionnaire
HIV Sexual and Injection Risk Behaviors
+7 moreVA-BRAVE 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,322,454 Total Patients Enrolled
Ismene L. Petrakis, MDStudy ChairVA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 Previous Clinical Trials
136 Total Patients Enrolled
Sandra Ann Springer, MDStudy ChairVA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a Veteran and under 18 years old.I have been on prescribed medication-assisted treatment for over 30 days.You have recently had thoughts of hurting yourself and needed to go to the hospital for help.I have used opioids in the last 30 days or just before entering a supervised setting.You have a moderate to severe opioid use disorder (OUD) based on a special interview called the Mini-International Neuropsychiatric Interview.I am seeking treatment for opioid use disorder and open to partial-agonist therapy.I have had severe side effects from buprenorphine or naloxone.I am seeking treatment for opioid use disorder and open to partial-agonist therapy.I have used opioids in the last 30 days or before entering a supervised setting.
Research Study Groups:
This trial has the following groups:- Group 1: Sublingual Arm
- Group 2: Injectable Arm
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04375033 — Phase 4
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