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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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
Information provided by (Responsible Party):
Yih-Ing Hser, University of California, Los Angeles
Tracking Information | |||||||||||
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First Submitted Date ICMJE | August 8, 2023 | ||||||||||
First Posted Date ICMJE | September 5, 2023 | ||||||||||
Last Update Posted Date | April 29, 2024 | ||||||||||
Estimated Study Start Date ICMJE | July 1, 2024 | ||||||||||
Estimated Primary Completion Date | November 30, 2024 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
Comparative effectiveness [ Time Frame: Week 2 through Week 14 of the trial ] Number or percentage of urine drug screen (UDS) results negative for opioids
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
Change History | |||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Descriptive Information | |||||||||||
Brief Title ICMJE | Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) | ||||||||||
Official Title ICMJE | Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings | ||||||||||
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. | ||||||||||
Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||
Study Design ICMJE | 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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||||
Estimated Enrollment ICMJE |
144 | ||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||
Estimated Study Completion Date ICMJE | December 30, 2024 | ||||||||||
Estimated Primary Completion Date | November 30, 2024 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT06023459 | ||||||||||
Other Study ID Numbers ICMJE | CTN-0102-XR UG1DA049435 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Yih-Ing Hser, University of California, Los Angeles | ||||||||||
Original Responsible Party | Same as current | ||||||||||
Current Study Sponsor ICMJE | Yih-Ing Hser | ||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of California, Los Angeles | ||||||||||
Verification Date | April 2024 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |