Comparing two methods of starting treatment for opioid use disorder
Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial
This study is testing whether a new way to start treatment for opioid use disorder can help people begin therapy without feeling withdrawal symptoms, compared to the standard method.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT04234191 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone for individuals with opioid use disorder. The study involves 50 participants who will be randomly assigned to one of the two treatment methods. Rapid micro-induction allows patients to begin treatment without experiencing withdrawal symptoms, potentially making it easier to start therapy. The trial is designed as a randomized, controlled, open-label superiority trial to assess which method is more beneficial for patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who have been diagnosed with opioid use disorder and are seeking opioid agonist treatment.
Not a fit: Patients with severe medical or psychiatric conditions that contraindicate the use of buprenorphine/naloxone or hydromorphone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and less distressing method for patients to initiate treatment for opioid use disorder.
How similar studies have performed: Other studies have explored micro-induction methods, but this specific comparison of rapid micro-induction versus standard induction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Vancouver, British Columbia
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Pouya Azar, MD, FRCPC, DABAM — University of British Columbia
- Study coordinator: Pouya Azar, MD, FRCPC, DABAM
- Email: pouya.rezazadeh-azar@ubc.ca
- Phone: 604-875-4111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.