Buprenorphine/Naloxone for Opioid Use Disorder

Overseen By James Wong, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of British Columbia

Must not be taking: Methadone, Buprenorphine

Disqualifiers: Severe medical, psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The current first-line treatment for opioid use disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal symptoms prior to induction, which can be a major barrier in starting treatment. Rapid micro-induction (also known as micro-dosing, low-dose induction) involves the administration of small, frequent does of bup/nx and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of bup/nx in patients with OUD.

Who Is on the Research Team?

Pouya Azar, MD, FRCPC, DABAM

Principal Investigator

University of British Columbia

Nickie Mathew, MD, MSc, FRCPC, ABPN, ABPM

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for adults over 19 with Opioid Use Disorder who are seeking treatment and can follow the study plan. They must not have used methadone or buprenorphine in the past 5 days, have no severe health conditions that conflict with treatments, and if female and able to have children, agree to use approved birth control.

Inclusion Criteria

You have an addiction to opioids, as defined by mental health professionals.

Individuals seeking Opioid Agonist Treatment (OAT);

Be willing and able to adhere to the study protocol and follow-up schedule;

Exclusion Criteria

I am allergic to buprenorphine/naloxone or hydromorphone.

There is a possibility that you may need to take medication during the trial that could be unsafe or prevent you from completing the study.

I don't have severe health or mental health conditions that make buprenorphine/naloxone or hydromorphone unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Induction

Participants undergo either rapid micro-induction or standard induction of buprenorphine/naloxone

3 days

Daily visits for monitoring and dose adjustments

Treatment

Participants continue receiving buprenorphine/naloxone with consolidated dosing

4 weeks

Weekly visits for monitoring and prescription pick-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Bi-weekly visits for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine/naloxone
• Hydromorphone

Trial Overview The study compares two ways of starting treatment for opioid addiction: 'Rapid Micro-Induction' which doesn't require withdrawal before beginning therapy, versus the 'Standard Induction' where patients must first go through withdrawal. It tests safety and effectiveness.

How Is the Trial Designed?

Group I: Rapid Micro-Induction Experimental Treatment 2 Interventions

On Day 1, participants will receive 0.5mg bup/nx sublingually (SL) every 3 hours (Q3H) - total daily dose of 4mg. On Day 2, they will receive 1mg bup/nx SL Q3H - total daily dose of 8mg. On Day 3, they will receive 8mg bup/nx SL once and 1-4mg bup/nx SL Q3H as needed (PRN) for withdrawal symptoms and/or craving and/or pain - maximum daily dose of 32mg. Afterwards, their day 3 total dose will be consolidated to once daily dosing - maximum daily dose of 32mg. On Days 1 and 2, participants will concurrently receive 1-48mg hydromorphone orally, intravenously, subcutaneously, or intramuscularly (PO/IV/SC/IM) Q1 to 3H PRN for withdrawal symptoms and/or craving and/or pain, titrated to effect (start at lower end of dosing range). Hydromorphone will be discontinued on Days 3 onwards.

Group II: Standard Induction Active Control 1 Intervention

Day 1 is initiated when participants score 11 or above on the Clinical Opiate Withdrawal Scale (COWS), and when they have been abstinent from short-acting opioids for at least 6-12 hours or from long-acting opioids for 24-72 hours. On Day 1, participants will start with 2 or 4mg bup/nx SL. If their COWS score increases, bup/nx will be held. If their COWS score remains the same or decreases, additional dosing can be done in increments of 2mg bup/nx SL every 2 hours (Q2H) as needed (PRN). On Day 2, dosing will be consolidated to once daily dosing. The maximum total daily dose for Day 1 and 2 is 32mg.

Buprenorphine/naloxone is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Suboxone for:

• Opioid dependence
• Opioid use disorder

Approved in United States as Suboxone for:

• Opioid dependence
• Opioid use disorder

Approved in Canada as Suboxone for:

• Opioid dependence
• Opioid use disorder

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Vancouver Coastal Health

Collaborator

Trials

41

Recruited

717,000+