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

Primary Purpose

Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Injectable extended-release buprenorphine
Sublingual buprenorphine-naloxone
Sponsored by
Yih-Ing Hser
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Opioid Use Disorder, Opioid Medication Assisted Treatment, Buprenorphine, Comparative Effectiveness Research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
  • Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
  • Oregon Health & Science University Primary Care Clinic, Scappoose
  • Harbor Regional Health - HarborCrest Behavioral Health
  • Providence Northeast Washington Medical Group
  • New Beginnings Recovery Clinic & Behavioral Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Injectable extended-release buprenorphine (XR-BUP)

Sublingual buprenorphine-naloxone (SL-BUP)

Arm Description

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 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).

Outcomes

Primary Outcome Measures

Comparative effectiveness
Number or percentage of urine drug screen (UDS) results negative for opioids

Secondary Outcome Measures

Feasibility of study implementation
Overall recruitment, study completion, study dropout during the 14-week intervention period, and qualitative feedback from clinic personnel and patients.
Acceptability of XR-BUP
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.

Full Information

First Posted
August 8, 2023
Last Updated
August 28, 2023
Sponsor
Yih-Ing Hser
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
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1. Study Identification

Unique Protocol Identification Number
NCT06023459
Brief Title
Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
Acronym
RXR
Official Title
Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yih-Ing Hser
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

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders
Keywords
Opioid Use Disorder, Opioid Medication Assisted Treatment, Buprenorphine, Comparative Effectiveness Research

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injectable extended-release buprenorphine (XR-BUP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sublingual buprenorphine-naloxone (SL-BUP)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Injectable extended-release buprenorphine
Other Intervention Name(s)
XR-BUP (Brixadi)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sublingual buprenorphine-naloxone
Other Intervention Name(s)
SL-BUP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparative effectiveness
Description
Number or percentage of urine drug screen (UDS) results negative for opioids
Time Frame
Week 2 through Week 14 of the trial
Secondary Outcome Measure Information:
Title
Feasibility of study implementation
Description
Overall recruitment, study completion, study dropout during the 14-week intervention period, and qualitative feedback from clinic personnel and patients.
Time Frame
through study completion, an average of 1 year
Title
Acceptability of XR-BUP
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Black, MPH
Phone
310-985-3696
Email
MBlack@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Boubion, BA
Email
CBoubion@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yih-Ing Hser, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larissa Mooney, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
City
Garberville
State/Province
California
ZIP/Postal Code
95542
Country
United States
Facility Name
Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
City
Gibson City
State/Province
Illinois
ZIP/Postal Code
60936
Country
United States
Facility Name
Oregon Health & Science University Primary Care Clinic, Scappoose
City
Scappoose
State/Province
Oregon
ZIP/Postal Code
97056
Country
United States
Facility Name
Harbor Regional Health - HarborCrest Behavioral Health
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98550
Country
United States
Facility Name
Providence Northeast Washington Medical Group
City
Colville
State/Province
Washington
ZIP/Postal Code
99114
Country
United States
Facility Name
New Beginnings Recovery Clinic & Behavioral Health Center
City
New Martinsville
State/Province
West Virginia
ZIP/Postal Code
26155
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://datashare.nida.nih.gov

Learn more about this trial

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

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