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 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT04036968
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-75
* Urine sample tests negative for common illicit substances of abuse, including cannabis
* Medically cleared to take study medications
* Are not pregnant or breast feeding
* Willing to comply with the study protocol.
Exclusion Criteria:
* Meet DSM-5 criteria for alcohol/substance use disorder
* Taking opioids for pain
* Previous adverse reaction to a cannabinoid product
* Prescribed and taking stimulants or benzodiazepines
* Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain
* Self-report any illicit drug or cannabinoid use in the past 7 days
* Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
* History of seizure disorder
* Have a known allergy to the study medications or sesame seed oil
* ALT or AST levels \>3x ULN and/or Bilirubin levels \>2x ULN during Screening
* Current (past 60-day) suicidal thoughts or past year history of suicidal behavior
* Taking medications contraindicated with hydromorphone or cannabidiol
* Have a history of clinically significant cardiac arrhythmias or vasopastic disease
* Have an abnormal and clinically-significant ECG
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04036968
Study Brief:
Protocol Section:
NCT04036968