Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

Launched by SAMUEL LUNENFELD RESEARCH INSTITUTE, MOUNT SINAI HOSPITAL · Jan 30, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called nabilone in patients with Inflammatory Bowel Disease (IBD) who are having surgery related to their condition. The trial will include 80 patients who are chronic opioid users, meaning they have been taking opioids for more than three months to manage pain. After their surgery, these patients will be divided into two groups. One group will receive nabilone along with their usual pain management, while the other group will receive a placebo (a substance with no active medication) instead. The main goals of the trial are to see if nabilone can help reduce the need for opioids and improve recovery by reducing inflammation and other IBD symptoms.

To be eligible for this trial, participants must be at least 25 years old, able to understand the study procedures, and give their consent to participate. They must also be scheduled for abdominal surgery related to IBD that lasts more than one hour and have safely tolerated nabilone before. Women who can become pregnant need to have a negative pregnancy test and use effective birth control during the study. Participants can expect to be monitored closely after their surgery and may experience either the effects of nabilone or the placebo as part of the trial. It’s important to note that this study is not yet recruiting participants, so individuals interested will need to wait until it begins.

Gender

ALL

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