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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered via sublingual tablet form.
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.
Vancouver General Hospital
Vancouver, British Columbia, Canada
RECRUITINGSuccessful induction of bup/nx with low levels of withdrawal
This is defined as the following: participants who remain in treatment until they have received a total daily dose of ≥ 8mg of bup/nx (successful induction), and score ≤ 12 on the COWS (low levels of withdrawal) from baseline to when they reach that dose.
Time frame: Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Illicit drug use
Assessed by urine drug screens (UDS) and Treatment Outcomes Profile (TOP).
Time frame: Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Drug use behaviour
Assessed by the Treatment Outcomes Profile (TOP).
Time frame: Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Treatment retention
Participants who pick up their prescription of bup/nx on Day 7. Assessed via the pharmacy database.
Time frame: Day 7
Craving
Assessed by the numeric craving scale.
Time frame: Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Pain
Assessed by the numeric pain scale.
Time frame: Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Physical health
Assessed by the health section of the Opiate Treatment Index (OTI).
Time frame: Baseline (both arms)
Client satisfaction
Assessed by the Treatment Perceptions Questionnaire (TPQ).
Time frame: Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Appearance of adverse events
Assessed by an adverse events report form.
Time frame: Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm)
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