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Opioid Agonist

Buprenorphine/Naloxone for Opioid Use Disorder

Phase 2

Recruiting

Led By Nickie Mathew, MD, FRCPC, ABPN, ABPM

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 19 years of age or older;

Be older than 18 years old

Must not have

Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone;

Diagnosis of severe medical or psychiatric conditions contraindicated for buprenorphine/naloxone or hydromorphone treatment;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 1 (standard induction arm) or day 2 (rapid micro-induction arm)

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing whether a rapid micro-induction of buprenorphine/naloxone is more effective and safe than the standard induction method in patients with Opioid Use Disorder.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to medications used (buprenorphine/naloxone or hydromorphone), as well as any typical risks associated with these drugs such as drowsiness, dizziness, constipation, headache, nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 19 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to buprenorphine/naloxone or hydromorphone.

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

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I have used methadone in the last 5 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (standard induction arm) or day 2 (rapid micro-induction arm)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (standard induction arm) or day 2 (rapid micro-induction arm)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (standard induction arm) or day 2 (rapid micro-induction arm) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Successful induction of bup/nx with low levels of withdrawal

Secondary study objectives

Appearance of adverse events

Client satisfaction

Craving

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Rapid Micro-InductionExperimental Treatment2 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 InductionActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naloxone

FDA approved

Hydromorphone

FDA approved

0 / 4Eligibility criteria met