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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 below
Select...
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 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

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 more

VA-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 16-24mg that is standard practice. While the target dose is 16-24mg, 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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,305,500 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

Media Library

Injectable subcutaneous buprenorphine (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04375033 — Phase 4
Opioid Use Disorder Research Study Groups: Sublingual Arm, Injectable Arm
Opioid Use Disorder Clinical Trial 2023: Injectable subcutaneous buprenorphine Highlights & Side Effects. Trial Name: NCT04375033 — Phase 4
Injectable subcutaneous buprenorphine (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375033 — Phase 4
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04375033 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions is injectable subcutaneous buprenorphine most frequently prescribed for?

"Subcutaneous buprenorphine is commonly utilized to address opioid dependency, however it may also be beneficial in ameliorating pruritus, pain and septic shock."

Answered by AI

How widely distributed is this clinical research throughout North America?

"The Minneapolis VA Health Care System in Minnesota, Dayton VA Medical Center in Ohio, and Hampton VA Medical Centre in Virginia are the three primary sites for this clinical trial. Additionally, there are an additional 18 locations offering enrollment opportunities."

Answered by AI

How has the efficacy of injectable subcutaneous buprenorphine been evaluated in other scientific trials?

"Presently, there are 56 Injectable subcutaneous buprenorphine trials in progress with 13 Phase 3 studies. These clinical experiments originate primarily from White River Junction, Vermont but can also be found at 235 other medical sites around the world."

Answered by AI

What has the Federal Drug Administration determined about utilizing injectable subcutaneous buprenorphine?

"Data from clinical trials and other sources show that injectable subcutaneous buprenorphine is a safe therapy, thus it has earned an estimated safety rating of 3."

Answered by AI

What outcome is this experiment striving to achieve?

"The purpose of this trial, monitored over a period of 52 weeks, is to promote opioid abstinence. Secondary objectives include gauging the intensity of an individual's craving for opioids via a 10-point Likert scale, assessing Post Traumatic Stress Disorder by employing the DSM-5 checklist and determining if any other addictive substances have been consumed using both Timeline Followback self-reporting measures as well as urine toxicology results."

Answered by AI

Are there still open opportunities to become participants in this research study?

"Affirmative. The information available on clinicaltrials.gov confirms this investigation is actively seeking participants with an initial posting date of November 3rd 2020, and the last update was June 1st 2022. There are 18 enrolment sites across the US searching for 952 individuals to participate in their trial."

Answered by AI

What is the estimated cohort size of participants in this trial?

"952 participants who meet the eligibility criteria are sought for this study. Qualifying patients may join from Minneapolis VA Health Care System, Minneapolis, MN or Dayton VA Medical Center, Dayton, OH in Minnesota and Ohio respectively."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Ohio
What site did they apply to?
Dayton VA Medical Center, Dayton, OH
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Phoenix VA Health Care System, Phoenix, AZ
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

Wanting to get off opioids. I am currently taking suboxone 3 times a day and if there is a shot I believe it would be much easier than worry about taking the pills. This epidemic is out of control and opiates almost took my life amd did in fact take my sisters life.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

~119 spots leftby Nov 2024