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Monthly shot vs. daily pills: new hope for opioid treatment in rural america?

NCT ID NCT06023459

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a once-monthly injection (XR-BUP) works as well as daily pills (SL-BUP) for treating opioid use disorder in rural settings. 140 adults with moderate to severe opioid use disorder took part. The goal was to see if the injection is practical and acceptable in rural clinics, and how it compares in reducing opioid use.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

140 people

The number who actually took part.

Started

Oct 2024

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Be ≥18 years of age 2. Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD 3. Be interested in receiving buprenorphine treatment for OUD 4. Be willing to be randomized to either SL-BUP or XR-BUP 5. Be willing to comply with all study procedures 6. Be in good general health, as determined by the study Medical Clinician based on medical/psychiatric histories and physical exam, to permit treatment in an outpatient setting 7. If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study intervention and agree to study-administered pregnancy testing during their participation in the study 8. Be able to speak English sufficiently to understand the study procedures 9. Be willing and able to provide written informed consent to participate in the study Exclusion Criteria: 1. Have evidence of a serious psychiatric disorder as assessed by the study Medical Clinician that would make participation difficult or unsafe (e.g., active psychosis, severe depression, or mania) 2. Have suicidal or homicidal ideation or behavior that requires immediate attention 3. Have a medical condition or serious medical illness that, in the opinion of the study Medical Clinician, would make study participation medically unsafe 4. Have been in treatment with naltrexone within 28 days of consent 5. Have been in methadone maintenance treatment within 28 days of consent 6. Be taking medication or require any medication that, in the judgment of the study Medical Clinician, could interact adversely with study medication 7. Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components 8. Be currently incarcerated or have pending legal action that could preclude participation in study activities 9. Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move) 10. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use, as determined by the study Medical Clinician, that would require a different level of care and preclude safe participation in the study 11. Be currently pregnant or breastfeeding or planning on conception

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • AppleGate Recovery El Dorado

    El Dorado, Arkansas, 71730, United States

  • Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness

    Gibson City, Illinois, 60936, United States

  • New Beginnings Recovery Clinic & Behavioral Health Center

    New Martinsville, West Virginia, 26155, United States

  • Oregon Health & Science University Primary Care Clinic, Scappoose

    Scappoose, Oregon, 97056, United States

  • Penobscot Community Health Care Inc. - Seaport Community Health Center

    Belfast, Maine, 04915, United States

  • Providence Northeast Washington Medical Group

    Colville, Washington, 99114, United States

  • Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital

    Garberville, California, 95542, United States

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Other studies related to the condition(s) this trial covers.