Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT02696434
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Additional criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02696434
Study Brief:
Protocol Section:
NCT02696434