- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06023459
Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) (RXR)
August 28, 2023 updated by: Yih-Ing Hser
Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings
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 use disorder (OUD) in rural settings.
We will randomize 144 eligible individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions: (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day target).Participants will receive study medication treatment for the 14 week-intervention period, including an initial ~2-week period of induction/stabilization.
The study will use a mixed-methods approach (participant assessments, study medication records, qualitative interviews) for assessing feasibility and acceptability, and results will include patient outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD in rural settings.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 study in rural settings, document the acceptability of the XR-BUP condition, and assess the comparative effectiveness of XR-BUP compared with SL-BUP.
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.
The XR-BUP condition will use Brixadi®/CAM2038 injectable, extended-release buprenorphine.
The measure for the main comparative effectiveness outcome is number of urine drug screen (UDS) results negative for opioids at scheduled assessments during Week 2 through Week 14 of the trial.
Missing or positive UDS for any non-prescribed opioid is considered UDS positive.
Study Type
Interventional
Enrollment (Estimated)
144
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Megan Black, MPH
- Phone Number: 310-985-3696
- Email: MBlack@mednet.ucla.edu
Study Contact Backup
- Name: Cynthia Boubion, BA
- Email: CBoubion@mednet.ucla.edu
Study Locations
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California
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Garberville, California, United States, 95542
- Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
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Illinois
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Gibson City, Illinois, United States, 60936
- Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
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Oregon
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Scappoose, Oregon, United States, 97056
- Oregon Health & Science University Primary Care Clinic, Scappoose
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Washington
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Aberdeen, Washington, United States, 98550
- Harbor Regional Health - HarborCrest Behavioral Health
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Colville, Washington, United States, 99114
- Providence Northeast Washington Medical Group
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West Virginia
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New Martinsville, West Virginia, United States, 26155
- New Beginnings Recovery Clinic & Behavioral Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
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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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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparative effectiveness
Time Frame: Week 2 through Week 14 of the trial
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Number or percentage of urine drug screen (UDS) results negative for opioids
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Week 2 through Week 14 of the trial
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of study implementation
Time Frame: through study completion, an average of 1 year
|
Overall recruitment, study completion, study dropout during the 14-week intervention period, and qualitative feedback from clinic personnel and patients.
|
through study completion, an average of 1 year
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Acceptability of XR-BUP
Time Frame: through study completion, an average of 1 year
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Initial patient medication preference prior to randomization, percentage of participants randomized to the XR-BUP condition who receive the first monthly injection, percentage of XR-BUP participants who receive at least the first two monthly injections, and qualitative feedback from clinic personnel and patients.
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through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yih-Ing Hser, PhD, University of California, Los Angeles
- Principal Investigator: Larissa Mooney, MD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2024
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
August 8, 2023
First Submitted That Met QC Criteria
August 28, 2023
First Posted (Actual)
September 5, 2023
Study Record Updates
Last Update Posted (Actual)
September 5, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Opioid-Related Disorders
- Narcotic-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Naloxone
- Buprenorphine, Naloxone Drug Combination
Other Study ID Numbers
- CTN-0102-XR
- UG1DA049435 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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/).
IPD Sharing Time Frame
After the main outcome(s) paper(s) have been published or 18 months after data lock, whichever comes first.
IPD Sharing Access Criteria
For more details on data sharing please visit https://datashare.nida.nih.gov
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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