Clareo Health | Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkermes, Inc.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing and able to provide informed consent
Willing and able to provide government-issued identification
Has a Body Mass Index (BMI) of 18.0-40.0 kg/m\^2
Has a history of opioid use disorder diagnosis for at least 6 months
Has a history of prescribed buprenorphine (or buprenorphine/naloxone) maintenance for the prior 3 or more consecutive months and is currently buprenorphine-maintained
Must be voluntarily seeking treatment for opioid use disorder and be motivated to receive antagonist therapy
Willing to abide by the contraception requirements for the duration of the study
Additional criteria may apply
You may not be if
Is pregnant, planning to become pregnant or breastfeeding during the study
Has a positive urine drug screen for opiates or oxycodone at screening
Has used methadone within 30 days prior to study Day -5
Has used naltrexone (oral or VIVITROL) within the 90 days prior to Day -5
Has a history of seizures or has received anticonvulsant therapy within the past 5 years for treatment of seizures (use of anticonvulsant during the past detoxification is not exclusionary)
Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
Has a history of hypersensitivity or adverse reaction to buprenorphine, naltrexone, VIVITROL, or naloxone
