Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) (RXR)
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ClinicalTrials.gov Identifier: NCT06023459 |
Recruitment Status :
Not yet recruiting
First Posted : September 5, 2023
Last Update Posted : April 29, 2024
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Condition or disease | Intervention/treatment | Phase |
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Opioid-Related Disorders Substance-Related Disorders Narcotic-Related Disorders | Drug: Injectable extended-release buprenorphine Drug: Sublingual buprenorphine-naloxone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. Participants will be randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96 in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings |
Estimated Study Start Date : | July 1, 2024 |
Estimated Primary Completion Date : | November 30, 2024 |
Estimated Study Completion Date : | December 30, 2024 |
Arm | Intervention/treatment |
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Experimental: Injectable extended-release buprenorphine (XR-BUP)
Participants will be randomly assigned to XR-BUP, with approximately 96 in the XR-BUP condition. The XR-BUP condition will use Brixadi/CAM2038 injectable, extended-release buprenorphine (Braeburn Pharmaceuticals, Inc.). After titrating to a stable dosage in approximately two weeks using weekly injection dosages as clinically indicated to relieve cravings and withdrawal symptoms, the target monthly dosage (128mg) of XR-BUP will be administered by injection at approximately Day 14 and approximately four weeks later in Week 6, with a third injection in Week 10. Dosage adjustments will be made as indicated for tolerability.
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Drug: Injectable extended-release buprenorphine
Participants randomized to the XR-BUP condition will receive XR-BUP study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.
Other Name: XR-BUP (Brixadi) |
Active Comparator: Sublingual buprenorphine-naloxone (SL-BUP)
Participants will be randomly assigned to SL-BUP with approximately 48 in the SL-BUP condition. The SL-BUP condition will use sublingual buprenorphine-naloxone, with a target maintenance daily dose range of 16-24mg as recommended for clinical practice. Titration to maintenance dosage will be attempted within the first two weeks of the SL-BUP condition. During the initial stabilization weeks, SL-BUP will be flexibly dosed as clinically indicated to relieve cravings and withdrawal symptoms, after which dosage adjustments will be based on clinical decisions by the site clinicians. The maintenance dosage of SL-BUP will be dispensed on a schedule similar to the XR-BUP injections (i.e., at approximately Day 14, Week 6, and Week 10).
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Drug: Sublingual buprenorphine-naloxone
Participants randomized to the SL-BUP condition will receive SL-BUP study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.
Other Name: SL-BUP |
- Comparative effectiveness [ Time Frame: Week 2 through Week 14 of the trial ]Number or percentage of urine drug screen (UDS) results negative for opioids
- Feasibility of study implementation [ Time Frame: through study completion, an average of 1 year ]Overall recruitment during the 14-week intervention period
- Acceptability of XR-BUP [ Time Frame: through study completion, an average of 1 year ]percentage of participants randomized to the XR-BUP condition who receive the first monthly injection
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023459
Contact: Megan Black, MPH | 310-985-3696 | MBlack@mednet.ucla.edu | |
Contact: Cynthia Boubion, BA | CBoubion@mednet.ucla.edu |
United States, California | |
Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital | |
Garberville, California, United States, 95542 | |
United States, Illinois | |
Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness | |
Gibson City, Illinois, United States, 60936 | |
United States, Oregon | |
Oregon Health & Science University Primary Care Clinic, Scappoose | |
Scappoose, Oregon, United States, 97056 | |
United States, Washington | |
Harbor Regional Health - HarborCrest Behavioral Health | |
Aberdeen, Washington, United States, 98550 | |
Providence Northeast Washington Medical Group | |
Colville, Washington, United States, 99114 | |
United States, West Virginia | |
New Beginnings Recovery Clinic & Behavioral Health Center | |
New Martinsville, West Virginia, United States, 26155 |
Principal Investigator: | Yih-Ing Hser, PhD | University of California, Los Angeles | |
Principal Investigator: | Larissa Mooney, MD | University of California, Los Angeles |
Responsible Party: | Yih-Ing Hser, Distinguished Research Professor, Department of Psychiatry and Behavioral Sciences, Geffen School of Medicine, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT06023459 |
Other Study ID Numbers: |
CTN-0102-XR UG1DA049435 ( U.S. NIH Grant/Contract ) |
First Posted: | September 5, 2023 Key Record Dates |
Last Update Posted: | April 29, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | This study will comply with the NIH Data Sharing Policy and Implementation Guidance and the HEAL Public Access and Data Sharing Policy. Primary data for this study will be available to the public in the NIDA Data Share repository, per NIDA CTN policy. For more details on data sharing please visit https://datashare.nida.nih.gov/.The main outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/). |
Time Frame: | After the main outcome(s) paper(s) have been published or 18 months after data lock, whichever comes first. |
Access Criteria: | For more details on data sharing please visit https://datashare.nida.nih.gov |
URL: | https://datashare.nida.nih.gov |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Opioid Use Disorder Opioid Medication Assisted Treatment Buprenorphine Comparative Effectiveness Research |
Substance-Related Disorders Opioid-Related Disorders Narcotic-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Buprenorphine, Naloxone Drug Combination Naloxone |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |