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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks starting on week 6 after randomization for 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Healthcare utilization

Opioid positivity

Secondary study objectives

Clinic Retention

Medication Satisfaction

Mortality

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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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