Recruiting
Phase 2

Rapid Micro-Induction & Standard Induction

Sponsor:

University of British Columbia

Code:

NCT04234191

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine/naloxone

Hydromorphone

Study Details

Brief summary:

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.

Conditions

Opioid Use Disorder

Study ID

NCT04234191

Start date

Aug 18, 2021

Status verified date

Jun, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Opioid Use Disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria;
2. Individuals seeking Opioid Agonist Treatment (OAT);
3. Be 19 years of age or older;
4. Be willing and able to adhere to the study protocol and follow-up schedule;
5. Be able to provide written informed consent to participate in the clinical trial.
6. If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study.

Exclusion Criteria:

1. Diagnosis of severe medical or psychiatric conditions contraindicated for buprenorphine/naloxone or hydromorphone treatment;
2. Anticipated deterioration of health due to discontinuation of medications that are contraindicated with buprenorphine/naloxone and/or hydromorphone;
3. Positive pregnancy test for women of childbearing potential;
4. Methadone use in the past 5 days;
5. Buprenorphine use in the past 5 days;
6. Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone;
7. Anticipation that the patient may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion;
8. Unwilling or unable to use an effective method of birth control approved by the study investigators throughout the study.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rapid Micro-Induction

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.

active comparator: Standard Induction

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.

Interventions

Buprenorphine/naloxone

Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered via sublingual tablet form.

Hydromorphone

Hydromorphone is an opioid used for managing pain, craving, and withdrawal. It is administered orally via tablet or liquid form; or administered intravenously, subcutaneously, or intramuscularly via liquid form.

Primary outcome measure

  • Successful induction of bup/nx with low levels of withdrawal [ Time Frame: Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm) ]

Central Contacts and Locations

Central contacts

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Pouya Azar, MD, FRCPC, DABAM

604-875-4111pouya.rezazadeh-azar@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jun 11, 2024

Last verified

Jun, 2024

Keywords

  • Buprenorphine/naloxone
  • Suboxone
  • Opioid agonist treatment
  • Micro-induction
  • Microdosing
  • Withdrawal Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-06-11.