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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

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

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 more

STOPIT 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.

Do I qualify?Apply below to find out

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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

Media Library

Extended Release Subcutaneous Buprenorphine (Partial Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05594121 — Phase 4

Opioid Use Disorder Research Study Groups: Immediate-release sublingual buprenorphine/naloxone (SL-BPN/NX), Extended-release subcutaneous buprenorphine (SC-BPN-XR)

Opioid Use Disorder Clinical Trial 2023: Extended Release Subcutaneous Buprenorphine Highlights & Side Effects. Trial Name: NCT05594121 — Phase 4

Extended Release Subcutaneous Buprenorphine (Partial Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05594121 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team accepting participants aged 45 or older for this trial?

"Participants of this research must fall between the ages of 18 and 65 to be admitted."

Answered by AI

What are the eligibility criteria for participating in this research?

"This clinical experiment is in search of 90 participants that suffer from moderate to severe opioid use disorder and are between the ages 18-65. The requirements for applicants include: being within the aforementioned age range, having a valid OAT prescription indicated for their condition, frequenting RAAM clinics located within North Simcoe Muskoka's Local Health Integrated Network, completing an induction and stabilization period with Suboxone® tablets or film at 8mg/2mg - 24mg/6 mg doses without any allergic reaction reported; COWS scores ≤12 (scale 0-48) over 24 hours; VAS score ≤20 (scale 0-100);"

Answered by AI

How many health care facilities are hosting this experiment?

"5 medical sites are presently accepting patients for this study, including RAAM Clinic (Barrie), RAAM Clinic (Midland) and RAAM Clinic (Wasaga Beach). Additionally, 2 more locations have been included."

Answered by AI

Are there any open vacancies for prospective participants in this research?

"As of today, this clinical trial is no longer recruiting participants. Initially posted on December 1st 2022 and last edited 10th October 2022, the study has closed its enrollment - though there are 291 other studies actively seeking applicants at present."

Answered by AI

Has the FDA green-lighted Extended-release subcutaneous buprenorphine (SC-BPN-XR) for use?

"The safety of Extended-release subcutaneous buprenorphine (SC-BPN-XR) was rated as a 3 due to the Phase 4 trial status, signifying that it is approved and available for use."

Answered by AI

What goals is this medical research attempting to achieve?

"This medical trial will observe the impact of healthcare utilization over a 12 month period, with assessments taking place every 7 days. Secondary outcomes include Quality-of-Life Score (measured via WHOQOL-BREF), Clinic Retention (percentage of patients who attend ≥80% of scheduled visits), and Medication Satisfaction (gauged through a single-item questionnaire). The latter two metrics are based on Likert scales ranging from 1 to 5/7 respectively, while QoL is assessed through a 26 item self report instrument that takes 15 to 20 minutes to complete."

Answered by AI

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