Status:
UNKNOWN
Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
This is a clinical trial of nabilone for patients with Inflammatory Bowel Disease (IBD) who are undergoing IBD-related surgery (Any abdominal surgery lasting for more than one hour). This study would ...
Detailed Description
Patients generally have pre-anesthetic visits 1-2 weeks prior to their scheduled operation. Patients identified by the Clinical Research Study Assistant (CRSA) based on inclusion and exclusion criteri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03422861
Start Date
December 1 2023
End Date
December 1 2024
Last Update
June 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5