Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder (STOPIT)
Moderate to Severe Opioid Use Disorder
About this trial
This is an interventional treatment trial for Moderate to Severe Opioid Use Disorder
Eligibility Criteria
Inclusion Criteria:
- Ages 18 to 65 years old
- OAT indicated for moderate- to severe-OUD
- Attend a RAAM clinic in the North Simcoe Muskoka Local Health Integrated Network for opiate substitution treatment
- Successfully completed induction and stabilization OAT with Suboxone® tablet or film defined as receiving 8mg/2mg to 24mg/6mg of Suboxone® for ≥7 days with no evidence of allergic reaction to Suboxone®, Clinical Opiate Withdrawal Scale (COWS) score ≤12 (scale:0-48) for ≥24 hours, and Opiate Craving Visual Analog Scale (VAS) score ≤20 (scale:0-100)) for ≥24 hours
- Must have an active Ontario Health Insurance Plan number
- Must have a telephone that can receive calls, text messages or emails
- Must have drug insurance coverage for either medication for duration of study or demonstrate ability to pay for the drug out-of-pocket
Exclusion Criteria:
- Receiving any investigational drug for OUD in previous 4 weeks
- Congenital long QTc syndrome or QTc prolongation at baseline by electrocardiogram (QTc ≥450 milliseconds in men and QTc ≥470 milliseconds in women)
- Pregnant or lactating women
- Women of childbearing potential who are not using an effective and reliable method of contraception
Sites / Locations
- Royal Victoria Regional Health Centre
- RAAM Clinic (Barrie)
- RAAM Clinic (Midland0
- RAAM Clinic (Orillia)
- RAAM Clinic (Wasaga Beach)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Extended-release subcutaneous buprenorphine (SC-BPN-XR)
Immediate-release sublingual buprenorphine/naloxone (SL-BPN/NX)
For eligible patients randomly allocated to SC-BPN-XR, the first dose will be administered at the time of randomization (Day 0). SC-BPN-XR comes in two formulations, 100 mg and 300 mg buprenorphine doses in a pre-filled syringe. SC-BPN-XR administration is by subcutaneous injection in the abdomen. SC-BPN-XR is administered at intervals ≥26 days. For patients randomly allocated to SC-BPN-XR, they will receive the 300 mg dose for the first 2 months, followed by the 100 mg dose every month until the end of the 12-month period. All SC-BPN-XR doses will be administered in clinics by trained personnel. All patients receiving SC-BPN-XR will have their vital signs monitored every 5 minutes for 15 minutes after the injection before leaving the clinic.
For eligible patients randomly allocated to SL-BPN/NX, the first study dose will be administered at the time of randomization (Day 0) and will match the SL-BPN/NX type (tablet versus film), route (sublingual versus buccal) and dose used for stabilization prior to study enrollment. For the first 2 weeks of the study period, all SL-BPN/NX administration will be directly observed at community pharmacies by trained personnel according to the usual standard of care. Subsequent to this period, healthcare providers and participants will develop a care plan for ongoing directly observed therapy vs unsupervised take-home dosing according to usual standard of care.