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Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

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ClinicalTrials.gov Identifier: NCT03422861
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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:

  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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Drug: Nabilone Drug: Placebos Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nabilone
U.S. FDA Resources

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 Name: 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Incidence of opioid related side effects [ Time Frame: Measured at 24, 48 and 72 hours ]
    Based on Opioid-Related Symptom Distress Scale

  3. 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

  4. 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)

  5. Crohn disease (CD) symptom severity [ Time Frame: Measured at baseline (pre-anesthetic clinic) and at 72 hrs ]
    Based on Harvey-Bradshaw Index (HBI)

  6. 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

  7. 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

  8. 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


Other Outcome Measures:
  1. 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

  2. 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)

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422861


Contacts
Contact: Naveed Siddiqui, M.D 416-586-4800 ext 5270 naveed.siddiqui@uhn.com
Contact: Zeev Friedman, M.D zeev.friedman@sinaihealthsystem.ca

Locations
Canada, Ontario
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Naveed Siddiqui, M.D    (416) 586-5270    Naveed.Siddiqui@uhn.ca   
Sub-Investigator: Zeev Friedman, M.D         
Sub-Investigator: Howard Meng, M.D         
Sub-Investigator: Matthew Sheppard, M.D         
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Naveed Siddiqui, M.D Mount Sinai Hospital Department of Anesthesia and Pain Management

Publications of Results:

Responsible Party: Dr. Naveed Siddiqui, Associate Professor, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT03422861     History of Changes
Other Study ID Numbers: NAB-2017
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Nabilone
Inflammatory Bowel Disease
Opioid

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Acute Pain
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Nabilone
Dronabinol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hallucinogens
Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents