Comparing oral and injectable buprenorphine for treating opioid use disorder in veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a long-acting injectable formulation of buprenorphine compared to the standard daily sublingual formulation in retaining veterans with opioid use disorder in treatment and sustaining opioid abstinence. It is an open-label, randomized, controlled trial involving 952 veterans over a 52-week period, with multiple study visits and a focus on various secondary outcomes such as substance use, overdose risk, and quality of life. Participants will be inducted on daily sublingual buprenorphine before being randomized to receive either the injectable or sublingual formulation.

Why it matters

Who can join: the full rules

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 or are in the process of starting on Medications for Opioid Use Disorder (MOUD) via clinical induction on SL-BUP/NLX
* Meets DSM-5 criteria for moderate to severe opioid use disorder (OUD) based on the Mini-International Neuropsychiatric Interview
* Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy

Exclusion Criteria:

* 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 4 milligrams (mg) - 32mg SL-BUP/NLX in 45 days or less
* Taking a form of prescribed maintenance Medications for Opioid Use Disorder (MOUD), e.g., methadone, buprenorphine or XR-NTX) continuously \>45 days prior to randomization
* Has a history of significant adverse effects from buprenorphine and/or naloxone
* Has experienced (within the past 2 weeks) recent suicidal or homicidal ideation that requires acute treatment or hospitalization
* Is unwilling or unable to provide consent
* Meets criteria for current (past month) DSM-5 severe sedative hypnotic use disorder based on the MINI Sedative, Hypnotic, or Anxiolytic Use Disorder (SHUD) module
* Anuria and/or dialysis
* Current moderate to severe COVID-19 symptoms with a risk of intubation or critical illness
* Medical, psychiatric, behavioral, or logistical condition which, in the judgement of the Local Site Investigator (LSI) or Co-Investigator (Co-I), requires a higher level of acute care and/or makes it unlikely the patient can participate in or complete the 52-week active phase of the study
* Is actively participating in an interventional clinical trial for which a waiver of dual-enrollment with CSP #2014 has not been obtained

Where it's running

• Phoenix VA Health Care System, Phoenix, AZ
  Phoenix, Arizona, United States Recruiting
• VA Long Beach Healthcare System, Long Beach, CA
  Long Beach, California, United States Recruiting
• VA Palo Alto Health Care System, Palo Alto, CA
  Palo Alto, California, United States Recruiting
• San Francisco VA Medical Center, San Francisco, CA
  San Francisco, California, United States Recruiting
• CERC (VISN1, West Haven, CT)
  West Haven, Connecticut, United States Recruiting
• Wilmington VA Medical Center, Wilmington, DE
  Wilmington, Delaware, United States Recruiting

Study contacts

• Study coordinator: Avron Spiro, PhD MS
• Email: avron.spiro@va.gov
• Phone: (857) 364-2888

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CBD for Opioid Dependence and Pain on Buprenorphine

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  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

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• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

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• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

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• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

  A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.

  Recruiting Rhode Island Hospital · Providence, Rhode Island · NCT07778394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.