Status:
ACTIVE_NOT_RECRUITING
Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
Lead Sponsor:
Yih-Ing Hser
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Conditions:
Opioid-Related Disorders
Substance-Related Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid ...
Detailed Description
This 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. The study objectives are to describe the feasibility of implementing the stud...
Eligibility Criteria
Inclusion
- Be ≥18 years of age
- Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD
- Be interested in receiving buprenorphine treatment for OUD
- Be willing to be randomized to either SL-BUP or XR-BUP
- Be willing to comply with all study procedures
- 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
- 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
- Be able to speak English sufficiently to understand the study procedures
- Be willing and able to provide written informed consent to participate in the study
Exclusion
- 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)
- Have suicidal or homicidal ideation or behavior that requires immediate attention
- Have a medical condition or serious medical illness that, in the opinion of the study Medical Clinician, would make study participation medically unsafe
- Have been in treatment with naltrexone within 28 days of consent
- Have been in methadone maintenance treatment within 28 days of consent
- Be taking medication or require any medication that, in the judgment of the study Medical Clinician, could interact adversely with study medication
- Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components
- Be currently incarcerated or have pending legal action that could preclude participation in study activities
- Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move)
- 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
- Be currently pregnant or breastfeeding or planning on conception
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06023459
Start Date
October 14 2024
End Date
February 28 2026
Last Update
December 31 2025
Active Locations (7)
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1
AppleGate Recovery El Dorado
El Dorado, Arkansas, United States, 71730
2
Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
Garberville, California, United States, 95542
3
Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
Gibson City, Illinois, United States, 60936
4
Penobscot Community Health Care Inc. - Seaport Community Health Center
Belfast, Maine, United States, 04915