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Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

Primary Purpose

Inflammatory Bowel Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nabilone
Placebos
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Diseases focused on measuring Nabilone, Inflammatory Bowel Disease, Opioid

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nabilone Treatment

Placebo Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total amount of opioid consumption postoperatively
All the narcotic consumption will be converted to IV morphine equivalents using standard conversation factors

Secondary Outcome Measures

Pain scores at rest and movement
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
Incidence of opioid related side effects
Based on Opioid-Related Symptom Distress Scale
Incidence of nabilone side effects at 24, 48, 72 hours
Including drowsiness, vertigo, blurred vision, sensation disturbance, dry mouth, ataxia, anorexia, asthenia, headache, orthostatic hypotension, seizure, syncope, confusion
Ulcerative Colitis (UC) symptom severity
Based on Simple Clinical Colitis Activity Index (SCCAI)
Crohn disease (CD) symptom severity
Based on Harvey-Bradshaw Index (HBI)
Time to first flatus
The number of hours/days elapsed post-surgically when the patient has flatus
Number of loose stools
Predominantly watery/non-formed stool. Bristol stool chart type 6 and 7
Length of hospital stay
The total number of hours the patient is admitted in the hospital

Full Information

First Posted
January 15, 2018
Last Updated
June 5, 2023
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03422861
Brief Title
Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients
Official Title
Nabilone Use for Acute Pain in Inflammatory Bowel Disease Patients With Chronic Opioid Use Undergoing Gastrointestinal Surgery: A Single-centered Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Nabilone, Inflammatory Bowel Disease, Opioid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nabilone Treatment
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo Treatment
Arm Type
Placebo Comparator
Arm Description
Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and placebo
Intervention Type
Drug
Intervention Name(s)
Nabilone
Other Intervention Name(s)
Cesamet
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
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
Primary Outcome Measure Information:
Title
Total amount of opioid consumption postoperatively
Description
All the narcotic consumption will be converted to IV morphine equivalents using standard conversation factors
Time Frame
For up to 72 hours after surgery
Secondary Outcome Measure Information:
Title
Pain scores at rest and movement
Description
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
Time Frame
Starting from discharge from post-anesthetic care unit (PACU), twice a day for 72 hours
Title
Incidence of opioid related side effects
Description
Based on Opioid-Related Symptom Distress Scale
Time Frame
Measured at 24, 48 and 72 hours
Title
Incidence of nabilone side effects at 24, 48, 72 hours
Description
Including drowsiness, vertigo, blurred vision, sensation disturbance, dry mouth, ataxia, anorexia, asthenia, headache, orthostatic hypotension, seizure, syncope, confusion
Time Frame
Measured at 24, 48, 72 hours
Title
Ulcerative Colitis (UC) symptom severity
Description
Based on Simple Clinical Colitis Activity Index (SCCAI)
Time Frame
Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Title
Crohn disease (CD) symptom severity
Description
Based on Harvey-Bradshaw Index (HBI)
Time Frame
Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Title
Time to first flatus
Description
The number of hours/days elapsed post-surgically when the patient has flatus
Time Frame
Assessed on a daily basis for occurrence of first flatus for up to 72 hrs
Title
Number of loose stools
Description
Predominantly watery/non-formed stool. Bristol stool chart type 6 and 7
Time Frame
Measured on a daily basis for up to 72 hrs after surgery
Title
Length of hospital stay
Description
The total number of hours the patient is admitted in the hospital
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
Other Pre-specified Outcome Measures:
Title
Patients' Global Impression of Change (PGIC)
Description
The changes(if any) in Activity Limitations, Symptoms, Emotions and overall quality of life
Time Frame
Measured at baseline and 72 hours
Title
Incidence of depression
Description
Based on Patient Health Questionnaire-9 (PHQ-9)
Time Frame
Measured at baseline, 24, 48 and 72 hours and also for 72 hours after discontinuation of study treatment
Title
Incidence of psychotropic adverse reactions of Nabilone using a questionnaire
Description
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
Time Frame
Measured for 72 hours after discontinuation of trial treatment
Title
Incidence of suicide
Description
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.
Time Frame
For 72 hours after discontinuation of trial treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naveed Siddiqui, M.D
Phone
416-586-4800
Ext
5270
Email
naveed.siddiqui@uhn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zeev Friedman, M.D
Email
zeev.friedman@sinaihealthsystem.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveed Siddiqui, M.D
Organizational Affiliation
Mount Sinai Hospital Department of Anesthesia and Pain Management
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveed Siddiqui, M.D
Phone
(416) 586-5270
Email
Naveed.Siddiqui@uhn.ca
First Name & Middle Initial & Last Name & Degree
Zeev Friedman, M.D
First Name & Middle Initial & Last Name & Degree
Howard Meng, M.D
First Name & Middle Initial & Last Name & Degree
Matthew Sheppard, M.D

12. IPD Sharing Statement

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Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

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