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

Substance-Related Disorders Clinical Trial

— RXR  

Official title:

Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06023459
• Other study ID #: CTN-0102-XR
• Secondary ID: UG1DA049435
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: Megan Black, MPH
• Phone: 310-985-3696
• Email: MBlack[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Harbor Regional Health - HarborCrest Behavioral Health	Aberdeen	Washington
United States	Providence Northeast Washington Medical Group	Colville	Washington
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	New Beginnings Recovery Clinic & Behavioral Health Center	New Martinsville	West Virginia
United States	Oregon Health & Science University Primary Care Clinic, Scappoose	Scappoose	Oregon

Sponsors (11)

Lead Sponsor	Collaborator
Yih-Ing Hser	Cornell University, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Oregon Health and Science University, RAND, The Emmes Company, LLC, University of California, Los Angeles, University of Illinois at Chicago, University of Washington, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative effectiveness	Number or percentage of urine drug screen (UDS) results negative for opioids	Week 2 through Week 14 of the trial
Secondary	Feasibility of study implementation	Overall recruitment during the 14-week intervention period	through study completion, an average of 1 year
Secondary	Acceptability of XR-BUP	percentage of participants randomized to the XR-BUP condition who receive the first monthly injection	through study completion, an average of 1 year