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:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02692157
Eligibility Criteria:
Inclusion Criteria:
* DSM V criteria for Opioid Use Disorder moderate-severe (304.00)
* Physically healthy
* Able to perform study procedures
* Normal body weight (BMI \<30 and \>17.5), and total body weight \>50 kg (110 lbs)
* Total testosterone in the laboratory normal range (250-1100 ng/dl)
* Current or history of intranasal opioid use.
* Must be willing to use adequate forms of contraception (e.g. condoms in combination with spermicide) for the duration of the study and a specified amount of time after participation.
Exclusion Criteria:
* On parole or probation
* Elevated liver function (i.e. AST and ALT \>2 times the upper limit of normal) or impaired renal function (creatinine within normal limits)
* 12-lead ECG-based repeated demonstration of QTcF \> 450 msec at screening
* HIV positive
* Any physical disorders that might make participation hazardous
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
59 Years
Study:
NCT02692157
Study Brief:
Protocol Section:
NCT02692157