Low-dose Buprenorphine Initiation for Opioid Use Disorder
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About 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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Any gender, aged 18 years or greater
Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
Disqualifiers
Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone
Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
Severe untreated mental illness, meaning psychosis or suicidality
Presence of an acute or chronic medical condition that would make participation medically hazardous
Trial design
Treatments tested in this trial
- buprenorphine-naloxone
- buprenorphine-naloxone
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Montefiore Medical Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov