Monthly shot vs. daily pills: new hope for opioid treatment in rural america?
NCT ID NCT06023459
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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140 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Jan 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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AppleGate Recovery El Dorado
El Dorado, Arkansas, 71730, United States
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Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
Gibson City, Illinois, 60936, United States
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New Beginnings Recovery Clinic & Behavioral Health Center
New Martinsville, West Virginia, 26155, United States
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Oregon Health & Science University Primary Care Clinic, Scappoose
Scappoose, Oregon, 97056, United States
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Penobscot Community Health Care Inc. - Seaport Community Health Center
Belfast, Maine, 04915, United States
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Providence Northeast Washington Medical Group
Colville, Washington, 99114, United States
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Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
Garberville, California, 95542, United States
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