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Comparing Oral and Injectable Buprenorphine for Opioid Use Disorder

This study is comparing two ways to treat Opioid Use Disorder (OUD) in Veterans: a daily pill called sublingual buprenorphine with naloxone (taken under the tongue) and a monthly shot of injectable buprenorphine. Researchers want to see if the monthly shot is better at helping Veterans stay in treatment and remain abstinent from opioids compared to the daily pill, which is the current standard of care. You may be able to join if you are a Veteran aged 18 or older, have moderate to severe OUD, and have used opioids recently. The study aims to enroll 952 Veterans and will follow them for 52 weeks, with a longer observation period for some outcomes.

Study design
This is an open-label, randomized, controlled trial involving 952 Veterans. Participants will be assigned to receive either daily sublingual buprenorphine with naloxone or monthly injectable buprenorphine.
What's involved
Participants will have study visits approximately every 28 days for 52 weeks to receive medication and for assessments. Opioid abstinence will be measured approximately every two weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be actively followed for 52 weeks, with a passive follow-up for opioid abstinence via EMR review for up to 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04375033

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
VA Office of Research and Development
~952 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:Sublingual buprenorphine with naloxoneInjectable subcutaneous buprenorphine

At a glance

Recruiting sites
16 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retention in Treatment Change
Measured over Approximately every 4 weeks until the first period of missed prescription medication coverage lasting at least 4 weeks through week 52
+1 more outcome measured

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

25 sites across 18 states
California3
Connecticut2
Florida2
Ohio2
Pennsylvania2
Virginia2
Alabama1
Arizona1

Study leadership

  • Ismene L. Petrakis, MD · STUDY_CHAIR · VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Sandra Ann Springer, MD · STUDY_CHAIR · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Who to contact

Avron Spiro, PhD MS
[email protected]
(857) 364-2888
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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

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 4mg - 32mg SL-BUP/NLX in 45 days or less.
Taking a form of prescribed maintenance 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 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.

What this trial measures

  • Retention in Treatment ChangeApproximately every 4 weeks until the first period of missed prescription medication coverage lasting at least 4 weeks through week 52

    Measured by receipt of prescribed study drug (via prescription or admission) and assessed via local study team records. Retention-in-treatment is a highly sensitive indicator of effective treatment as discontinuation is strongly associated with recurrence of use to opioids and risk for accidental drug poisoning.

  • Opioid AbstinenceApproximately every 2 weeks through 52 weeks (active phase) and via EMR review for up to 10 years (passive phase)

    Measured by Timeline Followback (self-report measure of substance use) and urine toxicology free of opioids. Both Timeline Followback and urine toxicology must indicate non-use to indicate abstinence.