Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04234191
Recruitment Status : Not yet recruiting
First Posted : January 21, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
Vancouver Coastal Health
Information provided by (Responsible Party):
Nickie Mathew, University of British Columbia

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 (micro-dosing) 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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: Buprenorphine/naloxone Drug: Hydromorphone Phase 2

Detailed Description:
This is a randomized, controlled, open-label superiority trial involving 50 individuals with OUD. Participants will be randomized into two arms: rapid micro-induction and standard induction (based on the American Society of Addiction Medicine Practice Guidelines and product monograph) of bup/nx.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
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 12mg bup/nx SL once and 1-4mg bup/nx SL Q3H as needed (PRN) - maximum daily dose of 24mg. On Day 4, their day 3 total dose will be consolidated to once daily dosing - maximum daily dose of 24mg. On Days 1 and 2, participants will concurrently receive 1-16mg hydromorphone orally, intravenously, subcutaneously, or intramuscularly (PO/IV/SC/IM) every 1-3 hours (Q1-3H) PRN to meet their opioid requirements, titrated to effect - maximum daily dose of 96mg. For the 1st dose of hydromorphone on Day 1, a maximum 8mg PO or 4mg SC/IV/IM dose will be given. Hydromorphone will be discontinued on Days 3 and 4.
Drug: Buprenorphine/naloxone
Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered orally via sublingual tablet form.
Other Name: Suboxone

Drug: 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.
Other Name: Dihydromorphinone, Dilaudid

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 2-4mg bup/nx SL. If they do not experience withdrawal symptoms 60-90 minutes after this dose, additional dosing can be done in increments of 2-4mg bup/nx SL. The suggested total dose target for Day 1 is 8-12mg. On Day 2, participants will start with a dose equal to the total amount of bup/nx SL administered on Day 1. The dose will be then titrated in increments or decrements of 2-8mg bup/nx SL to a level that holds the patient in treatment and suppresses opioid withdrawal. On Day 3, their day 2 total dose will be consolidated to once daily dosing. For both Days 2 and 3, the suggested total daily dose is at least 8mg, recommended 12-16mg, maximum daily dose of 24mg.
Drug: Buprenorphine/naloxone
Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered orally via sublingual tablet form.
Other Name: Suboxone




Primary Outcome Measures :
  1. Successful induction of bup/nx with low levels of withdrawal [ Time Frame: Randomization to Day 3 (Standard Induction Arm) or Day 4 (Rapid Micro-Induction Arm) ]
    This is defined as the following: participants who remain in treatment until they have received a total daily dose of ≥ 12mg of bup/nx (successful induction), and score ≤ 12 on the COWS (low levels of withdrawal) from the time of randomization to when they reach that dose.


Secondary Outcome Measures :
  1. Illicit drug use [ Time Frame: Baseline (both arms), Day 3 (Standard Induction Arm), Day 4 (Rapid Micro-Induction Arm) ]
    Assessed by urine drug screens (UDS).

  2. Drug use behaviour [ Time Frame: Baseline (both arms), Day 3 (Standard Induction Arm), Day 4 (Rapid Micro-Induction Arm) ]
    Assessed by the Treatment Outcomes Profile (TOP).

  3. Treatment retention [ Time Frame: Day 5 ]
    Participants who pick up their prescription of bup/nx on Day 7. Assessed via the pharmacy database.

  4. Craving [ Time Frame: Baseline to Day 3 (both arms), Day 4 (Rapid Micro-Induction Arm) ]
    Assessed by a Visual analogue scale (0-10 scale).

  5. Pain [ Time Frame: Baseline to Day 3 (both arms), Day 4 (Rapid Micro-Induction Arm) ]
    Assessed by a Visual analogue scale (0-10 scale).

  6. Physical health [ Time Frame: Baseline (both arms) ]
    Assessed by the health section of the Opiate Treatment Index (OTI).

  7. Client satisfaction [ Time Frame: Day 3 (Standard Induction Arm), Day 4 (Rapid Micro-Induction Arm) ]
    Assessed by the Treatment Perceptions Questionnaire (TPQ).

  8. Appearance of adverse events [ Time Frame: Randomization to Day 3 (Standard Induction Arm) or Day 4 (Rapid Micro-Induction Arm) ]
    Assessed by an adverse events report form.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Not experiencing mild to moderate opioid withdrawal after the last dose of methadone;
  5. Positive urine test for methadone;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234191


Contacts
Layout table for location contacts
Contact: Pouya Azar, MD, FRCPC, DABAM 604-875-4111 ext 54788 pouya.rezazadeh-azar@ubc.ca

Locations
Layout table for location information
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Pouya Azar, MD, FRCPC    604-875-4111 ext 54788    pouya.rezazadeh-azar@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health
Investigators
Layout table for investigator information
Principal Investigator: Pouya Azar, MD, FRCPC, DABAM University of British Columbia
Principal Investigator: Nickie Mathew, MD, FRCPC, ABPN, ABPM University of British Columbia
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nickie Mathew, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04234191    
Other Study ID Numbers: H19-03254
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nickie Mathew, University of British Columbia:
Buprenorphine/naloxone
Suboxone
Opioid agonist treatment
Micro-induction
Microdosing
Withdrawal Management
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Hydromorphone
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists