Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
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 BMI of 18.0-40.0 kg/m\^2
Has a physiologic dependence on opioids
Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
Wiling 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 used Buprenorphine within 7 days prior to randomization
Has used Methadone within 14 days prior to randomization
Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
Has a history of seizures or has received anticonvulsant therapy within the past 5 years
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, or Naloxone
Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
Has significant suicidal ideation or behavior within the past year
Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
Is court mandated to receive treatment for opioid use disorder
Additional criteria may apply
Clareo Health | Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
