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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02617628
Eligibility Criteria:
Inclusion Criteria:
* Opioid dependent with physiological features according to Diagnostic and Statistical Manual of Mental Disorders-5th edition
* Interested in extended release naltrexone treatment
* Eligible to have health benefits reinstated
* Detoxified and able to pass a naloxone challenge (e.g. no withdrawal within 30 minutes after receiving 0.8 mg naloxone I.M. and documented by a score \<5 on the Clinical Opiate Withdrawal Scale
* Age 18 or above
* Not being transferred to serve a longer sentence in a State or Federal prison
* Provide their address or phone number along with the names and contact information of 3 or more persons likely to know where they can be reached with permission to contact them if unable to be reached in other ways
* Able to speak and read English and provide informed consent
* able to correctly answer 9 of 10 study quiz items
* not pregnant and agree to the use of an acceptable form of birth control
* can access to NET Steps via car or public or other transportation after reentry
Exclusion Criteria:
* Planning to move from the Philadelphia area within the next 6 months
* Neurological, cardiovascular, renal, hepatic (Alanine aminotransferase, Aspartate aminotransferase or Gamma-glutamyl transpeptidase \>3 times top limit of normal) or another medical disorder that seriously impairs or makes hazardous ability to participate
* Active tuberculosis
* Currently psychotic, homicidal, suicidal
* Uncontrolled seizure disorder
* History of allergy to naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or any other components of the diluent
* Chronic pain for which opioids are needed
* Sentenced to naltrexone Treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02617628
Study Brief:
Protocol Section:
NCT02617628