Overview
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.
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.
Eligibility
Inclusion Criteria:
- Opioid Use Disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria;
- Individuals seeking Opioid Agonist Treatment (OAT);
- Be 19 years of age or older;
- Be willing and able to adhere to the study protocol and follow-up schedule;
- Be able to provide written informed consent to participate in the clinical trial.
- 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:
- Diagnosis of severe medical or psychiatric conditions contraindicated for buprenorphine/naloxone or hydromorphone treatment;
- Anticipated deterioration of health due to discontinuation of medications that are contraindicated with buprenorphine/naloxone and/or hydromorphone;
- Positive pregnancy test for women of childbearing potential;
- Methadone use in the past 5 days;
- Buprenorphine use in the past 5 days;
- Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone;
- 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;
- Unwilling or unable to use an effective method of birth control approved by the study investigators throughout the study.