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Partial Opioid Agonist
Monthly vs Daily Buprenorphine Formulations for Opioid Use Disorder (STOPIT Trial)
Phase 4
Waitlist Available
Led By Giulio DiDiodato, PhD
Research Sponsored by Royal Victoria Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks starting on week 6 after randomization for 12 months
Awards & highlights
STOPIT Trial Summary
This trial will study whether an expensive opioid treatment (Sublocade) is better than the cheaper option (Suboxone).
Who is the study for?
Adults aged 18-65 with moderate to severe opioid use disorder (OUD) can join this trial if they've been successfully treated with Suboxone for at least a week without allergies, have low withdrawal and craving scores, and can pay for the treatment or are insured. They must be in North Simcoe Muskoka's RAAM clinic network, have an active health insurance plan in Ontario, and a phone.Check my eligibility
What is being tested?
The study compares two buprenorphine treatments for OUD: a monthly extended-release injection (Sublocade) versus daily immediate-release tablets or films taken under the tongue (Suboxone). It aims to show if Sublocade is better and more cost-effective to justify wider insurance coverage.See study design
What are the potential side effects?
Buprenorphine may cause side effects like nausea, vomiting, constipation, headaches, sweating, sleep problems, pain at the injection site for Sublocade users. There's also a risk of allergic reactions or hormone changes over time.
STOPIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks starting on week 6 after randomization for 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks starting on week 6 after randomization for 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Healthcare utilization
Opioid positivity
Secondary outcome measures
Clinic Retention
Medication Satisfaction
Mortality
+1 moreSTOPIT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Extended-release subcutaneous buprenorphine (SC-BPN-XR)Experimental Treatment1 Intervention
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.
Group II: Immediate-release sublingual buprenorphine/naloxone (SL-BPN/NX)Active Control1 Intervention
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.
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Who is running the clinical trial?
Royal Victoria Hospital, CanadaLead Sponsor
17 Previous Clinical Trials
10,327 Total Patients Enrolled
Giulio DiDiodato, PhDPrincipal InvestigatorRoyal Victoria Regional Health Centre
1 Previous Clinical Trials
156 Total Patients Enrolled
Philip Wong, MNPrincipal InvestigatorRoyal Victoria Regional Health Centre
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am prescribed opioid agonist therapy for severe opioid use disorder.My heart's electrical activity is normal, without long QT syndrome or abnormal QTc times.I have not taken any experimental drugs for opioid use disorder in the last 4 weeks.I've been on Suboxone for over a week without allergies, low withdrawal symptoms, and low craving.I am between 18 and 65 years old.I have insurance or can pay out-of-pocket for medication during the study.I have a phone that can get calls, texts, or emails.I am receiving opiate substitution treatment at a RAAM clinic in North Simcoe Muskoka.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate-release sublingual buprenorphine/naloxone (SL-BPN/NX)
- Group 2: Extended-release subcutaneous buprenorphine (SC-BPN-XR)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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