Low-Dose Buprenorphine for Opioid Use Disorder
Trial Summary
Will I have to stop taking my current medications?
If you are currently taking FDA-approved medications for opioid use disorder, like methadone, buprenorphine, or naltrexone, you must stop at least 14 days before joining the study.
What data supports the effectiveness of the drug buprenorphine-naloxone for opioid use disorder?
Is low-dose buprenorphine generally safe for humans?
Buprenorphine, often combined with naloxone, is generally well tolerated and considered safe for treating opioid use disorder in adults and adolescents over 15 years old. While it has a potential for abuse similar to other opioids, its combination with naloxone helps reduce misuse, and adverse effects are usually mild and rare.16789
How is the drug Buprenorphine-naloxone unique for treating opioid use disorder?
Buprenorphine-naloxone is unique because it combines buprenorphine, which helps reduce cravings and withdrawal symptoms, with naloxone, which deters misuse by causing withdrawal symptoms if injected. This combination aims to improve treatment adherence and reduce the risk of misuse compared to other treatments.1381011
What is the purpose of this trial?
The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.
Research Team
Benjamin T Hayes, MD, MS, MPH
Principal Investigator
Montefiore Medical Center
Eligibility Criteria
Adults over 18 with opioid use disorder who are willing to follow study procedures and can take sublingual medication. They must not be pregnant, lactating, or have cognitive impairments that prevent consent. Participants should not be on other FDA-approved medications for opioid use disorder or have severe mental illness.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either an 8-day low-dose buprenorphine initiation protocol or treatment as usual, with study visits at baseline, week 2, and week 4.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at 2-week and 6-week visits.
Treatment Details
Interventions
- Buprenorphine-naloxone
Buprenorphine-naloxone is already approved in United States, European Union for the following indications:
- Opioid use disorder
- Opioid dependence
- Opioid use disorder
- Opioid dependence
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor