← Back to Search

Nabilone for Acute Pain in Inflammatory Bowel Disease

N/A

Waitlist Available

Led By Naveed Siddiqui, M.D

Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age≥25 years

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, 24, 48 and 72 hours and also for 72 hours after discontinuation of study treatment

Awards & highlights

Study Summary

This trial is testing whether nabilone, a cannabinoid, can help patients with Inflammatory Bowel Disease who are undergoing surgery.

Who is the study for?

This trial is for adults over 25 with Inflammatory Bowel Disease (IBD) who are chronic opioid users, have used cannabis or cannabinoids, and are undergoing IBD-related abdominal surgery. They must not be pregnant or planning a family soon, use contraception effectively, and have previously tolerated nabilone without severe side effects.Check my eligibility

What is being tested?

The study tests if nabilone can help manage post-operative pain better than a placebo in patients using IVPCA after IBD surgery. It aims to reduce the need for opioids and improve recovery by leveraging nabilone's anti-inflammatory properties.See study design

What are the potential side effects?

Nabilone may cause drowsiness, dry mouth, an elevated mood or euphoria, headache, dizziness, red eyes due to conjunctival blood vessel dilation (bloodshot eyes), decreased blood pressure (hypotension), fast heartbeat (tachycardia).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 25 years old or older.

Select...

I am a male and agree to use contraception correctly for 3 months after the last dose and not to donate sperm during this time.

Select...

I am scheduled for abdominal surgery for IBD that will last over an hour.

Select...

I have used nabilone before without severe side effects.

Select...

I am not pregnant and will use birth control during and for a month after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, 24, 48 and 72 hours and also for 72 hours after discontinuation of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, 24, 48 and 72 hours and also for 72 hours after discontinuation of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, 24, 48 and 72 hours and also for 72 hours after discontinuation of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total amount of opioid consumption postoperatively

Secondary outcome measures

Crohn disease (CD) symptom severity

Incidence of nabilone side effects at 24, 48, 72 hours

Incidence of opioid related side effects

+5 more

Other outcome measures

Incidence of depression

Incidence of psychotropic adverse reactions of Nabilone using a questionnaire

Incidence of suicide

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Nabilone TreatmentActive Control1 Intervention

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

Group II: Placebo TreatmentPlacebo Group1 Intervention

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

0 / 5Eligibility criteria met