Opioid Use Disorder
Conditions
Keywords
Buprenorphine/naloxone, Suboxone, Opioid agonist treatment, Micro-induction, Microdosing, Withdrawal Management
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.
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.
Interventions
DRUGBuprenorphine/naloxone
Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered via sublingual tablet form.
DRUGHydromorphone
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.
Sponsors
Vancouver Coastal Health
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful induction of bup/nx with low levels of withdrawal | Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Illicit drug use | Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm) | Assessed by urine drug screens (UDS) and Treatment Outcomes Profile (TOP). |
| Drug use behaviour | Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm) | Assessed by the Treatment Outcomes Profile (TOP). |
| Treatment retention | Day 7 | Participants who pick up their prescription of bup/nx on Day 7. Assessed via the pharmacy database. |
| Appearance of adverse events | Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm) | Assessed by an adverse events report form. |
| Pain | Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm) | Assessed by the numeric pain scale. |
| Physical health | Baseline (both arms) | Assessed by the health section of the Opiate Treatment Index (OTI). |
| Client satisfaction | Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm) | Assessed by the Treatment Perceptions Questionnaire (TPQ). |
| Craving | Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm) | Assessed by the numeric craving scale. |
Countries
Canada
Contacts
Primary ContactPouya Azar, MD, FRCPC, DABAM
Backup ContactJames Wong, MSc
Outcome results
None listed