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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT03422861
Eligibility Criteria:
Inclusion Criteria:
* Age≥25 years
* Be able to understand the study procedures
* Voluntarily provide written informed consent
* Be planned to undergo abdominal surgery related to IBD lasting more than an hour
* previously and safely tolerated side effects of nabilone use
* Chronic opioid users who are defined as opioid consumption of 20mg oral morphine equivalent per day for \> 3 months
* Negative pregnancy test for females of child bearing potential and they should use acceptable birth controlling measures such as barriers, Intra Uterine Devices (IUDs) or Hormonal contraceptives consistently and correctly for one month post last dose of study drug
* Male participants must also agree to consent and correct use of acceptable contraception during and for 3 months post last dose of study drug and agree not to donate sperm during this time period (90 days)
Exclusion Criteria:
* Age under 25
* Are allergic or hypersensitive to cannabis or any cannabinoid-Have severe liver( Acute hepatitis or CHILD Score ≥2), kidney, heart (any acute condition, decompensated Heart failure or Metabolic equivalent of task(MET) \< 4) or lung disease
* Have a personal or family history of serious psychotic disorders such as schizophrenia or psychosis
* Are pregnant, or are planning to get pregnant, or are breast feeding
* Are a man who wishes to start a family during duration of trial
* Have a history of alcohol or substance use disorders, including: hallucinogens (phencyclidine or similarly acting arylcyclohexylamines), other hallucinogens such as LSD, inhalants, sedatives, hypnotics, anxiolytics, and stimulants (including amphetamine-type substances, cocaine, and other stimulants).
* History of hypertension on medication
* Clinically significant lactose intolerant
* Nabilone treatment within the past month before surgery
* Diazepam or secobarbital use before surgery
* Hypersensitivity to Cesamet or any of its excipients
* Elderly (\>65 years)
* History of emotional disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT03422861
Study Brief:
Protocol Section:
NCT03422861