Clinical trial NCT06023459: Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
Official title: Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Keywords: Opioid Use Disorder
Opioid Medication Assisted Treatment
Buprenorphine
Comparative Effectiveness Research
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
name: The Emmes Company, LLC
name: University of California, Los Angeles
name: RAND
name: Cornell University
name: Oregon Health and Science University
name: University of Illinois at Chicago
name: University of Washington
name: West Virginia University
First posted: 2023-09-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Be ≥18 years of age
2. Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD
3. Be interested in receiving buprenorphine treatment for OUD
4. Be willing to be randomized to either SL-BUP or XR-BUP
5. Be willing to comply with all study procedures
6. 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
7. 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
8. Be able to speak English sufficiently to understand the study procedures
9. Be willing and able to provide written informed consent to participate in the study

Exclusion Criteria:

1. 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)
2. Have suicidal or homicidal ideation or behavior that requires immediate attention
3. Have a medical condition or serious medical illness that, in the opinion of the study Medical Clinician, would make study participation medically unsafe
4. Have been in treatment with naltrexone within 28 days of consent
5. Have been in methadone maintenance treatment within 28 days of consent
6. Be taking medication or require any medication that, in the judgment of the study Medical Clinician, could interact adversely with study medication
7. Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components
8. Be currently incarcerated or have pending legal action that could preclude participation in study activities
9. Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move)
10. 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
11. Be currently pregnant or breastfeeding or planning on conception

Primary outcomes:
measure: Comparative effectiveness
timeFrame: Week 2 through Week 14 of the trial
Secondary outcomes:
measure: Feasibility of study implementation
timeFrame: through study completion, an average of 1 year
measure: Acceptability of XR-BUP
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: El Dorado
country: United States
facility: AppleGate Recovery El Dorado
state: Arkansas
city: Garberville
country: United States
facility: Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
state: California
city: Gibson City
country: United States
facility: Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
state: Illinois
city: Belfast
country: United States
facility: Penobscot Community Health Care Inc. - Seaport Community Health Center
state: Maine
city: Scappoose
country: United States
facility: Oregon Health & Science University Primary Care Clinic, Scappoose
state: Oregon
city: Colville
country: United States
facility: Providence Northeast Washington Medical Group
state: Washington
city: New Martinsville
country: United States
facility: New Beginnings Recovery Clinic & Behavioral Health Center
state: West Virginia
Study officials:
affiliation: University of California, Los Angeles
name: Yih-Ing Hser, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Larissa Mooney, MD
role: PRINCIPAL_INVESTIGATOR
References: