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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

Be planned to undergo abdominal surgery related to IBD lasting more than an hour

Must not have

History of hypertension on medication

Age under 25

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

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.

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.

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

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I am 25 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on medication for high blood pressure.

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I am younger than 25 years old.

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I do not have severe liver, kidney, heart, or lung disease.

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I have taken Nabilone within the last month before my surgery.

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I am older than 65 years.

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I have taken Diazepam or secobarbital before surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total amount of opioid consumption postoperatively

Secondary study objectives

Crohn disease (CD) symptom severity

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

Incidence of opioid related side effects

+5 more

Other study objectives

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 / 8Eligibility criteria met