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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT03837860
Eligibility Criteria:
Inclusion Criteria:
* Adult patients between 21 to 65 years of age, capable of understanding and providing consent in English, and capable of complying with the outcome instruments used.
* Recreational opioid use (i.e. defined as prescription opioid use for nontherapeutic purposes on at least 10 occasions within the previous year and at least once in the 12 weeks prior to screening)
* Reported tolerated doses to opioid medications
Exclusion Criteria:
* Currently receiving pharmacotherapy for psychiatric disorder, current suicide risk, or past history of major psychiatric disorder such as bipolar disorder/psychosis
* Presence of dementia
* Current neuroleptic medication in past 30 days
* Pregnancy
* Positive drug urine test for Barbiturates, Benzodiazepines, Methadone, and Buprenorphine.
* Subjects with a prolonged QT interval greater than 430ms (i.e. QTc \>430ms)
* Subjects with a heart rate of less than 60 or greater than 100bpm will be assessed by a physician for symptomatic bradycardia/tachycardia and eligibility determined on a case-by-case basis
* Subjects with serum potassium and/or magnesium outside of normal range of our institutional laboratory within the past three months from time of screening.
* Subjects who appears intoxicated on the day of study visit by an on-site physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03837860
Study Brief:
Protocol Section:
NCT03837860