Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 include a total of 80 patients undergoing general surgery who will have Intravenous Patient Controlled Analgesia (IVPCA) after surgery. It is the intention to randomize these patients postoperatively into 2 groups of 40 patients:

1. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and nabilone as per protocol.

2. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and placebo as per protocol.

The goal is two-fold. One is to demonstrate that patients will benefit from post-operative nabilone administration to achieve/maintain the opioid-sparing and pain modulation effects. Second is to demonstrate patients will benefit from the anti-inflammatory and immunomodulatory effects of nabilone to alleviate IBD symptoms and enhance recovery.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Treatments: Analgesics, Opioid; Dronabinol; Nabilone

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