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Opioid Agonist

Rapid Micro-Induction 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 older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.

Eligible Conditions

Opioid Use Disorder

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Successful induction of bup/nx with low levels of withdrawal

Secondary outcome measures

Appearance of adverse events

Client satisfaction

Craving

+5 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,466,966 Total Patients Enrolled

Vancouver Coastal HealthOTHER_GOV

37 Previous Clinical Trials

711,862 Total Patients Enrolled

Nickie Mathew, MD, FRCPC, ABPN, ABPMPrincipal InvestigatorUniversity of British Columbia

Frequently Asked Questions

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

What conditions is Rapid Micro-Induction typically utilized to treat?

"Rapid Micro-Induction can be applied to manage symptoms such as coughing, opioid use, and pruritus."

Answered by AI

How does the safety profile of Rapid Micro-Induction compare to other treatments?

"Our team at Power graded Rapid Micro-Induction's safety as a 2 due to being in the Phase 2 trial stage, where there is evidence of its security but not yet any proof of effectiveness."

Answered by AI

How many participants are enlisted for this scientific investigation?

"Affirmative. According to clinicaltrials.gov, this research is in the process of recruiting individuals for participation and was first made available on August 18th 2021. As of October 5th 2022, it has been looking for 50 volunteers at a single site."

Answered by AI

Have prior investigations been conducted involving Rapid Micro-Induction?

"Currently, 69 medical studies are actively assessing the efficacy of Rapid Micro-Induction. Of these trials, 16 have reached Phase 3 and 257 sites across the country are playing host to them. Boston Massachusetts is disproportionately represented in this research with a majority of active trials based there."

Answered by AI

Are there opportunities to volunteer for this medical research at the present time?

"Affirmative. The trial's entry on clinicaltrials.gov indicates that the research was initially posted on August 18th 2021 and last amended October 5th 2022, with a goal of recruiting 50 participants at one site."

Answered by AI

Recent research and studies

Journal of Addiction MedicineJournal

American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use

Kampman, Kyle, and Margaret Jarvis. 2015. “American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use”. Journal of Addiction Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/adm.0000000000000166.

clinicaltrials.govStudy

Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

Nickie Mathew 2021. "Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04234191.

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