History of Changes for Study: NCT06023459

Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) (RXR)

Latest version (submitted April 25, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			August 28, 2023	None (earliest Version on record)
2			April 25, 2024	Study Status and Outcome Measures

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Study NCT06023459
Submitted Date: August 28, 2023 (v1)

Study Identification


Unique Protocol ID:	CTN-0102-XR
Brief Title:	Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) (RXR)
Official Title:	Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings
Secondary IDs:	UG1DA049435 [U.S. NIH Grant/Contract]

Study Status


Record Verification:	August 2023
Overall Status:	Not yet recruiting
Study Start:	January 1, 2024
Primary Completion:	November 30, 2024 [Anticipated]
Study Completion:	December 30, 2024 [Anticipated]

First Submitted:	August 8, 2023
First Submitted that Met QC Criteria:	August 28, 2023
First Posted:	September 5, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	August 28, 2023
Last Update Posted:	September 5, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Yih-Ing Hser
Responsible Party:	Sponsor-Investigator Investigator: Yih-Ing Hser Official Title: Distinguished Research Professor, Department of Psychiatry and Behavioral Sciences, Geffen School of Medicine Affiliation: University of California, Los Angeles
Collaborators:	National Institute on Drug Abuse (NIDA) National Institutes of Health (NIH) The Emmes Company, LLC University of California, Los Angeles RAND Cornell University Oregon Health and Science University University of Illinois at Chicago University of Washington West Virginia University

Study Description

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 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.

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.

Conditions


Conditions:	Opioid-Related Disorders Substance-Related Disorders Narcotic-Related Disorders
Keywords:	Opioid Use Disorder Opioid Medication Assisted Treatment Buprenorphine Comparative Effectiveness Research

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
	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.
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	144 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

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.

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 Names:

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).

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 Names:

SL-BUP

Outcome Measures


Primary Outcome Measures:
1.	Comparative effectiveness [ Time Frame: Week 2 through Week 14 of the trial ] Number or percentage of urine drug screen (UDS) results negative for opioids
Secondary Outcome Measures:
1.	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.
2.	Acceptability of XR-BUP [ Time Frame: through study completion, an average of 1 year ] 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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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

Contacts/Locations


Central Contact Person:	Megan Black, MPH Telephone: 310-985-3696 Email: MBlack@mednet.ucla.edu
Central Contact Backup:	Cynthia Boubion, BA Email: CBoubion@mednet.ucla.edu
Study Officials:	Yih-Ing Hser, PhD Principal Investigator University of California, Los Angeles
	Larissa Mooney, MD Principal Investigator University of California, Los Angeles
Locations:	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

IPDSharing


Plan to Share IPD:	Yes 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/).
	Supporting Information:
	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

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