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NCT04375033RECRUITINGIRB Ready

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

(VA-BRAVE)

Sponsored by VA Office of Research and Development

Quick Self-Assessment

See if you qualify and express your interest

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1 of 952 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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).

Who Can Participate

Inclusion Criteria

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
Have started on MOUD via clinical induction on SL-BUP/NLX
Meets DSM-5 criteria for moderate to severe OUD based on the Mini-International Neuropsychiatric Interview
Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy

Exclusion Criteria

Is a Veteran less than 18 years of age
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
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).
Taking a form of pre

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

952 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

VA Office of Research and Development

Study Locations

Choose your preferred location or select flexible during enrollment

TERMINATED

Tuscaloosa

Alabama

Location available
View Tuscaloosa location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Long Beach

California

Location available
View Long Beach location page
RECRUITING

Palo Alto

California

Location available
View Palo Alto location page
RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

West Haven

Connecticut

Location available
View West Haven location page
ACTIVE_NOT_RECRUITING

West Haven

Connecticut

Location available
View West Haven location page
RECRUITING

Wilmington

Delaware

Location available
View Wilmington location page
RECRUITING

Bay Pines

Florida

Location available
View Bay Pines location page

๐Ÿ“ And 16 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Opioid Use Disorder Treatment in Tuscaloosa?

Join others in Alabama exploring innovative treatment options through clinical research

Opioid Use Disorder Treatment Options in Tuscaloosa, Alabama

If you're searching for Opioid Use Disorder treatment in Tuscaloosa, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Tuscaloosa, Phoenix, Long Beach and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Opioid Use Disorder. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 952 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Opioid Use Disorder?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Opioid Use Disorder

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Opioid Use Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04375033. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.