Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

June 5, 2023 updated by: Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Nabilone Use for Acute Pain in Inflammatory Bowel Disease Patients With Chronic Opioid Use Undergoing Gastrointestinal Surgery: A Single-centered Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 criteria will be approached regarding this study in the pre-anesthetic clinic. Patients will be made aware of the components of the study and the CRSA will be present to answer any questions. Patients have until the day of the surgery after admission to the hospital (generally 4 hours before the planned procedure) to decide whether they want to be enrolled in this study. In most cases patients will have approximately 1-2 weeks from being made aware of this study to come to a decision. Even patients who have been scheduled for pre-anesthetic clinic visit less than 1 week prior to surgery will still have >24 hrs to make decisions. Those admitted on the day of surgery may still be able to participate provided they have at least 4 hrs to review the study and have their questions answered by the study team. Patients will have access to a contact phone number in case they have additional questions. Baseline patient data will be collected once consent is obtained. On the day of surgery, administration of general anesthesia (GA) will be protocolized. Patients will cease their current oral opioid while on IV opioids. After the surgery, Patients will be randomly allocated into either placebo or intervention arm using a computerized random generator. Treatment regimen will involve nabilone capsule administration starting with 1mg twice a day orally first administered on post-operative day (POD) #0. The patient will be continued on this medication for 72 hours. Enrolled patients will document their pain scores and other data points as per study outcomes measured. The CRSA will follow for nabilone-related adverse effects at 24hrs, 48hrs, and 72hours post-operatively. Study subjects will also be followed up for psychotropic adverse reactions of nabilone (including hallucination, depressed mood, anxiety reactions, and euphoria) for 3 days after discontinuation of study treatment. This follow up will be made by the CRSA during the subject's stay in the hospital, or by telephone call made after discharge from the hospital. Any surgical complication will be recorded up to 30 days after the operation. The CRSA will administer study questionnaires and assist patients in their completion. The CRSA will work with the principal investigator (PI) to capture all requirements for study evaluation.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
        • Contact:
        • Sub-Investigator:
          • Zeev Friedman, M.D
        • Sub-Investigator:
          • Howard Meng, M.D
        • Sub-Investigator:
          • Matthew Sheppard, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nabilone Treatment
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
Drug: Nabilone
Treatment regimen will involve nabilone capsule administration starting with 1mg BID orally first administered on POD #0. The patient will be continued on this medication for 72 hours
Other Names:
  • Cesamet
Placebo Comparator: Placebo Treatment
Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and placebo
Drug: Placebos
Treatment regimen will involve placebo capsule administration, identical in colour, shape, size, taste and smell to the nabilone capsules, starting orally first administered on POD #0. The patient will be continued on this medication for 72 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of opioid consumption postoperatively
Time Frame: For up to 72 hours after surgery
All the narcotic consumption will be converted to IV morphine equivalents using standard conversation factors
For up to 72 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores at rest and movement
Time Frame: Starting from discharge from post-anesthetic care unit (PACU), twice a day for 72 hours
Based on visual analogue scale (VAS) scoring system (0-10), where score of 0 refers to no pain and a score of 10 refers to the worst pain imaginable
Starting from discharge from post-anesthetic care unit (PACU), twice a day for 72 hours
Incidence of opioid related side effects
Time Frame: Measured at 24, 48 and 72 hours
Based on Opioid-Related Symptom Distress Scale
Measured at 24, 48 and 72 hours
Incidence of nabilone side effects at 24, 48, 72 hours
Time Frame: Measured at 24, 48, 72 hours
Including drowsiness, vertigo, blurred vision, sensation disturbance, dry mouth, ataxia, anorexia, asthenia, headache, orthostatic hypotension, seizure, syncope, confusion
Measured at 24, 48, 72 hours
Ulcerative Colitis (UC) symptom severity
Time Frame: Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Based on Simple Clinical Colitis Activity Index (SCCAI)
Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Crohn disease (CD) symptom severity
Time Frame: Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Based on Harvey-Bradshaw Index (HBI)
Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Time to first flatus
Time Frame: Assessed on a daily basis for occurrence of first flatus for up to 72 hrs
The number of hours/days elapsed post-surgically when the patient has flatus
Assessed on a daily basis for occurrence of first flatus for up to 72 hrs
Number of loose stools
Time Frame: Measured on a daily basis for up to 72 hrs after surgery
Predominantly watery/non-formed stool. Bristol stool chart type 6 and 7
Measured on a daily basis for up to 72 hrs after surgery
Length of hospital stay
Time Frame: Measured in hours, starting from arrival to post-anesthetic care unit (PACU) to the time of discharge from hospital for up to 10 days
The total number of hours the patient is admitted in the hospital
Measured in hours, starting from arrival to post-anesthetic care unit (PACU) to the time of discharge from hospital for up to 10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Global Impression of Change (PGIC)
Time Frame: Measured at baseline and 72 hours
The changes(if any) in Activity Limitations, Symptoms, Emotions and overall quality of life
Measured at baseline and 72 hours
Incidence of depression
Time Frame: Measured at baseline, 24, 48 and 72 hours and also for 72 hours after discontinuation of study treatment
Based on Patient Health Questionnaire-9 (PHQ-9)
Measured at baseline, 24, 48 and 72 hours and also for 72 hours after discontinuation of study treatment
Incidence of psychotropic adverse reactions of Nabilone using a questionnaire
Time Frame: Measured for 72 hours after discontinuation of trial treatment
We have included the most common psychotropic adverse effects of Nabilone in a questionnaire which consists of: depressed mood, euphoria, hallucination, anxiety, dissociation, suicidal ideation or behaviour
Measured for 72 hours after discontinuation of trial treatment
Incidence of suicide
Time Frame: For 72 hours after discontinuation of trial treatment
Based on Columbia Suicide Severity Rating Scale (C-SSRS), a suicidal ideation rating scale which identifies behaviors indicative of an individual's intent to complete suicide. A "yes" answer at any time to any one of the questions necessitates further evaluation and making appropriate referrals.
For 72 hours after discontinuation of trial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

  • Principal Investigator: Naveed Siddiqui, M.D, Mount Sinai Hospital Department of Anesthesia and Pain Management

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAB-2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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