Narcotic-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
Conditions
Keywords
Opioid Use Disorder, Opioid Medication Assisted Treatment, Buprenorphine, Comparative Effectiveness Research
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.
Interventions
DRUGInjectable 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.
DRUGSublingual 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.
Sponsors
Yih-Ing Hser
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative effectiveness | Week 2 through Week 14 of the trial | Number of urine drug screen (UDS) results negative for opioids |
| Feasibility of study implementation | 14 weeks of the trial starting at randomization | The extent to which XR-BUP can be implemented in rural clinic settings, including recruitment, consent, study completion. |
| Acceptability | 14 weeks of the trial starting at screening | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYih-Ing Hser, PhD
University of California, Los Angeles
PRINCIPAL_INVESTIGATORLarissa Mooney, MD
University of California, Los Angeles
Outcome results
None listed