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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
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.
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.
AppleGate Recovery El Dorado
El Dorado, Arkansas, United States
Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
Garberville, California, United States
Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
Gibson City, Illinois, United States
Penobscot Community Health Care Inc. - Seaport Community Health Center
Belfast, Maine, United States
Oregon Health & Science University Primary Care Clinic, Scappoose
Scappoose, Oregon, United States
Providence Northeast Washington Medical Group
Colville, Washington, United States
New Beginnings Recovery Clinic & Behavioral Health Center
New Martinsville, West Virginia, United States
Comparative effectiveness
Number of urine drug screen (UDS) results negative for opioids
Time frame: Week 2 through Week 14 of the trial
Feasibility of study implementation
The extent to which XR-BUP can be implemented in rural clinic settings, including recruitment, consent, study completion.
Time frame: 14 weeks of the trial starting at randomization
Acceptability
Acceptability of XR-BUP by those implementing or receiving XR-BUP if it is agreeable or satisfaction, percent receiving the first monthly injection, percent receiving at least the first two monthly injection
Time frame: 14 weeks of the trial starting at screening
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