Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients
NCT ID: NCT03422861
Last Updated: 2023-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2023-12-31
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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
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
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
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
65 Years
ALL
Yes
Sponsors
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Samuel Lunenfeld Research Institute, Mount Sinai Hospital
OTHER
Responsible Party
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Dr. Naveed Siddiqui
Associate Professor
Principal Investigators
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Naveed Siddiqui, M.D
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital Department of Anesthesia and Pain Management
Locations
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Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Toth C, Mawani S, Brady S, Chan C, Liu C, Mehina E, Garven A, Bestard J, Korngut L. An enriched-enrolment, randomized withdrawal, flexible-dose, double-blind, placebo-controlled, parallel assignment efficacy study of nabilone as adjuvant in the treatment of diabetic peripheral neuropathic pain. Pain. 2012 Oct;153(10):2073-2082. doi: 10.1016/j.pain.2012.06.024. Epub 2012 Aug 23.
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Other Identifiers
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NAB-2017
Identifier Type: -
Identifier Source: org_study_id
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