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Monthly shot vs. daily pill: which works better for opioid addiction?

NCT ID NCT04375033

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study compares a once-monthly injectable buprenorphine to the standard daily sublingual tablet (with naloxone) for treating opioid use disorder in 952 veterans. The goal is to see which formulation better keeps people in treatment and helps them stay opioid-free over 48 weeks. Participants will be randomly assigned to one of the two treatments and followed for a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buprenorphine (injectable or sublingual with naloxone)
What this could lead to
If the monthly injection works better, it could offer a more convenient and effective way to help people stay in treatment and avoid relapse.
What could go wrong
This is a Phase 4 study, so the drugs are already approved; however, the injectable may not prove superior, and individual results vary. Risks include injection site reactions and potential for misuse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 952 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid-use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bay Pines VA Healthcare System, Pay Pines, FL

    RECRUITING

    Bay Pines, Florida, 33744-0000, United States

  • CERC (VISN1, West Haven, CT)

    RECRUITING

    West Haven, Connecticut, 06516-2770, United States

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    RECRUITING

    Milwaukee, Wisconsin, 53295-0001, United States

  • Dayton VA Medical Center, Dayton, OH

    RECRUITING

    Dayton, Ohio, 45428, United States

  • Hampton VA Medical Center, Hampton, VA

    RECRUITING

    Hampton, Virginia, 23667, United States

  • Huntington VA Medical Center, Huntington, WV

    RECRUITING

    Huntington, West Virginia, 25704-9300, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    TERMINATED

    Cleveland, Ohio, 44106, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    TERMINATED

    Minneapolis, Minnesota, 55417-2309, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    RECRUITING

    Gainesville, Florida, 32608-1135, United States

  • Philadelphia MultiService Center, Philadelphia, PA

    RECRUITING

    Philadelphia, Pennsylvania, 19106, United States

  • Phoenix VA Health Care System, Phoenix, AZ

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Providence VA Medical Center, Providence, RI

    TERMINATED

    Providence, Rhode Island, 02908-4734, United States

  • Salem VA Medical Center, Salem, VA

    RECRUITING

    Salem, Virginia, 24153-6404, United States

  • San Francisco VA Medical Center, San Francisco, CA

    RECRUITING

    San Francisco, California, 94121-1563, United States

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL

    TERMINATED

    Tuscaloosa, Alabama, 35404-5015, United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    TERMINATED

    Boston, Massachusetts, 02130, United States

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    ACTIVE_NOT_RECRUITING

    West Haven, Connecticut, 06516-2770, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    RECRUITING

    Long Beach, California, 90822, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    RECRUITING

    Dallas, Texas, 75216-7167, United States

  • VA Palo Alto Health Care System, Palo Alto, CA

    RECRUITING

    Palo Alto, California, 94304-1207, United States

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    TERMINATED

    Pittsburgh, Pennsylvania, 15240, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    RECRUITING

    Seattle, Washington, 98108-1532, United States

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    RECRUITING

    Salt Lake City, Utah, 84148-0001, United States

  • White River Junction VA Medical Center, White River Junction, VT

    TERMINATED

    White River Junction, Vermont, 05001-3833, United States

  • Wilmington VA Medical Center, Wilmington, DE

    RECRUITING

    Wilmington, Delaware, 19805-4917, United States

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