Inflammatory Bowel DiseasesNCT03422861
Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients
A study testing Nabilone in people with Inflammatory Bowel Diseases, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Nabilone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
Zeev Friedman, M.D contact
Canada1 site
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Naveed Siddiqui, M.D, (416) 586-5270, Naveed.Siddiqui@uhn.ca
Zeev Friedman, M.D
About this study
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
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Nabilone, Placebos
- Keywords
- Nabilone, Inflammatory Bowel Disease, Opioid
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabiloneDrug
Also called Cesamet
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
PlacebosDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Nabilone Treatment | Active comparator | 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 Receives: Drug: Nabilone |
| Placebo Treatment | Placebo comparator | Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of opioid consumption postoperatively
All the narcotic consumption will be converted to IV morphine equivalents using standard conversation factors
Measured: For up to 72 hours after surgery
Secondary outcomes (8)
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
Measured: Starting from discharge from post-anesthetic care unit (PACU), twice a day for 72 hours
Incidence of opioid related side effects
Based on Opioid-Related Symptom Distress Scale
Measured: Measured at 24, 48 and 72 hours
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
Measured: Measured at 24, 48, 72 hours
Ulcerative Colitis (UC) symptom severity
Based on Simple Clinical Colitis Activity Index (SCCAI)
Measured: Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Crohn disease (CD) symptom severity
Based on Harvey-Bradshaw Index (HBI)
Measured: Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Time to first flatus
The number of hours/days elapsed post-surgically when the patient has flatus
Measured: Assessed on a daily basis for occurrence of first flatus for up to 72 hrs
Number of loose stools
Predominantly watery/non-formed stool. Bristol stool chart type 6 and 7
Measured: Measured on a daily basis for up to 72 hrs after surgery
Length of hospital stay
The total number of hours the patient is admitted in the hospital
Measured: Measured in hours, starting from arrival to post-anesthetic care unit (PACU) to the time of discharge from hospital for up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study startDec 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Investigators
- Naveed Siddiqui, M.D, Principal investigator, Mount Sinai Hospital Department of Anesthesia and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422861
- Sponsor's protocol ID
- NAB-2017
- Status last verified
- Jun 2023
- First submitted
- 15 Jan 2018
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lal S, Prasad N, Ryan M, Tangri S, Silverberg MS, Gordon A, Steinhart H. Cannabis use amongst patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):891-6. doi: 10.1097/MEG.0b013e328349bb4c.
PubMed 21795981Di Sabatino A, Battista N, Biancheri P, Rapino C, Rovedatti L, Astarita G, Vanoli A, Dainese E, Guerci M, Piomelli D, Pender SL, MacDonald TT, Maccarrone M, Corazza GR. The endogenous cannabinoid system in the gut of patients with inflammatory bowel disease. Mucosal Immunol. 2011 Sep;4(5):574-83. doi: 10.1038/mi.2011.18. Epub 2011 Apr 6.
PubMed 21471961Singh UP, Singh NP, Singh B, Price RL, Nagarkatti M, Nagarkatti PS. Cannabinoid receptor-2 (CB2) agonist ameliorates colitis in IL-10(-/-) mice by attenuating the activation of T cells and promoting their apoptosis. Toxicol Appl Pharmacol. 2012 Jan 15;258(2):256-67. doi: 10.1016/j.taap.2011.11.005. Epub 2011 Nov 18.
PubMed 22119709Izzo AA, Sharkey KA. Cannabinoids and the gut: new developments and emerging concepts. Pharmacol Ther. 2010 Apr;126(1):21-38. doi: 10.1016/j.pharmthera.2009.12.005. Epub 2010 Feb 1.
PubMed 20117132Alhouayek M, Muccioli GG. The endocannabinoid system in inflammatory bowel diseases: from pathophysiology to therapeutic opportunity. Trends Mol Med. 2012 Oct;18(10):615-25. doi: 10.1016/j.molmed.2012.07.009. Epub 2012 Aug 21.
PubMed 22917662Naftali T, Lev LB, Yablecovitch D, Half E, Konikoff FM. Treatment of Crohn's disease with cannabis: an observational study. Isr Med Assoc J. 2011 Aug;13(8):455-8.
PubMed 21910367Lahat A, Lang A, Ben-Horin S. Impact of cannabis treatment on the quality of life, weight and clinical disease activity in inflammatory bowel disease patients: a pilot prospective study. Digestion. 2012;85(1):1-8. doi: 10.1159/000332079. Epub 2011 Nov 17.
PubMed 22095142Naftali T, Bar-Lev Schleider L, Dotan I, Lansky EP, Sklerovsky Benjaminov F, Konikoff FM. Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1276-1280.e1. doi: 10.1016/j.cgh.2013.04.034. Epub 2013 May 4.
PubMed 23648372Kelly S, Jhaveri MD, Sagar DR, Kendall DA, Chapman V. Activation of peripheral cannabinoid CB1 receptors inhibits mechanically evoked responses of spinal neurons in noninflamed rats and rats with hindpaw inflammation. Eur J Neurosci. 2003 Oct;18(8):2239-43. doi: 10.1046/j.1460-9568.2003.02957.x.
PubMed 14622184Ibrahim MM, Rude ML, Stagg NJ, Mata HP, Lai J, Vanderah TW, Porreca F, Buckley NE, Makriyannis A, Malan TP Jr. CB2 cannabinoid receptor mediation of antinociception. Pain. 2006 May;122(1-2):36-42. doi: 10.1016/j.pain.2005.12.018. Epub 2006 Mar 23.
PubMed 16563625Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA. 2015 Jun 23-30;313(24):2456-73. doi: 10.1001/jama.2015.6358.
PubMed 26103030Salio C, Fischer J, Franzoni MF, Mackie K, Kaneko T, Conrath M. CB1-cannabinoid and mu-opioid receptor co-localization on postsynaptic target in the rat dorsal horn. Neuroreport. 2001 Dec 4;12(17):3689-92. doi: 10.1097/00001756-200112040-00017.
PubMed 11726775Smith PA, Selley DE, Sim-Selley LJ, Welch SP. Low dose combination of morphine and delta9-tetrahydrocannabinol circumvents antinociceptive tolerance and apparent desensitization of receptors. Eur J Pharmacol. 2007 Oct 1;571(2-3):129-37. doi: 10.1016/j.ejphar.2007.06.001. Epub 2007 Jun 12.
PubMed 17603035Abrams DI, Couey P, Shade SB, Kelly ME, Benowitz NL. Cannabinoid-opioid interaction in chronic pain. Clin Pharmacol Ther. 2011 Dec;90(6):844-51. doi: 10.1038/clpt.2011.188. Epub 2011 Nov 2.
PubMed 22048225Beaulieu P. Effects of nabilone, a synthetic cannabinoid, on postoperative pain. Can J Anaesth. 2006 Aug;53(8):769-75. doi: 10.1007/BF03022793.
PubMed 16873343
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03422861
- Acronym / sponsor ID
- NAB-2017
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Nabilone, Inflammatory Bowel Disease, Opioid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nabilone Treatment | Active comparator | Drug: NabilonePatients 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 |
| Placebo Treatment | Placebo comparator | Drug: PlacebosPatients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and placebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NabiloneAlso: CesametTreatment 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 | Drug | Nabilone Treatment |
| PlacebosTreatment 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 | Drug | Placebo Treatment |
Primary outcome
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
8 secondary outcomes
Pain scores at rest and movement
Time frame: 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
Incidence of nabilone side effects at 24, 48, 72 hours
Time frame: Measured at 24, 48, 72 hours
Ulcerative Colitis (UC) symptom severity
Time frame: 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
Time to first flatus
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Results publication: PubMed 21795981Lal S, Prasad N, Ryan M, Tangri S, Silverberg MS, Gordon A, Steinhart H. Cannabis use amongst patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):891-6. doi: 10.1097/MEG.0b013e328349bb4c.
- Results publication: PubMed 21471961Di Sabatino A, Battista N, Biancheri P, Rapino C, Rovedatti L, Astarita G, Vanoli A, Dainese E, Guerci M, Piomelli D, Pender SL, MacDonald TT, Maccarrone M, Corazza GR. The endogenous cannabinoid system in the gut of patients with inflammatory bowel disease. Mucosal Immunol. 2011 Sep;4(5):574-83. doi: 10.1038/mi.2011.18. Epub 2011 Apr 6.
- Results publication: PubMed 22119709Singh UP, Singh NP, Singh B, Price RL, Nagarkatti M, Nagarkatti PS. Cannabinoid receptor-2 (CB2) agonist ameliorates colitis in IL-10(-/-) mice by attenuating the activation of T cells and promoting their apoptosis. Toxicol Appl Pharmacol. 2012 Jan 15;258(2):256-67. doi: 10.1016/j.taap.2011.11.005. Epub 2011 Nov 18.
- Results publication: PubMed 20117132Izzo AA, Sharkey KA. Cannabinoids and the gut: new developments and emerging concepts. Pharmacol Ther. 2010 Apr;126(1):21-38. doi: 10.1016/j.pharmthera.2009.12.005. Epub 2010 Feb 1.
- Results publication: PubMed 22917662Alhouayek M, Muccioli GG. The endocannabinoid system in inflammatory bowel diseases: from pathophysiology to therapeutic opportunity. Trends Mol Med. 2012 Oct;18(10):615-25. doi: 10.1016/j.molmed.2012.07.009. Epub 2012 Aug 21.
- Results publication: PubMed 21910367Naftali T, Lev LB, Yablecovitch D, Half E, Konikoff FM. Treatment of Crohn's disease with cannabis: an observational study. Isr Med Assoc J. 2011 Aug;13(8):455-8.
- Results publication: PubMed 22095142Lahat A, Lang A, Ben-Horin S. Impact of cannabis treatment on the quality of life, weight and clinical disease activity in inflammatory bowel disease patients: a pilot prospective study. Digestion. 2012;85(1):1-8. doi: 10.1159/000332079. Epub 2011 Nov 17.
- Results publication: PubMed 23648372Naftali T, Bar-Lev Schleider L, Dotan I, Lansky EP, Sklerovsky Benjaminov F, Konikoff FM. Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1276-1280.e1. doi: 10.1016/j.cgh.2013.04.034. Epub 2013 May 4.
- Results publication: PubMed 14622184Kelly S, Jhaveri MD, Sagar DR, Kendall DA, Chapman V. Activation of peripheral cannabinoid CB1 receptors inhibits mechanically evoked responses of spinal neurons in noninflamed rats and rats with hindpaw inflammation. Eur J Neurosci. 2003 Oct;18(8):2239-43. doi: 10.1046/j.1460-9568.2003.02957.x.
- Results publication: PubMed 16563625Ibrahim MM, Rude ML, Stagg NJ, Mata HP, Lai J, Vanderah TW, Porreca F, Buckley NE, Makriyannis A, Malan TP Jr. CB2 cannabinoid receptor mediation of antinociception. Pain. 2006 May;122(1-2):36-42. doi: 10.1016/j.pain.2005.12.018. Epub 2006 Mar 23.
- Results publication: PubMed 26103030Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA. 2015 Jun 23-30;313(24):2456-73. doi: 10.1001/jama.2015.6358.
- Results publication: PubMed 11726775Salio C, Fischer J, Franzoni MF, Mackie K, Kaneko T, Conrath M. CB1-cannabinoid and mu-opioid receptor co-localization on postsynaptic target in the rat dorsal horn. Neuroreport. 2001 Dec 4;12(17):3689-92. doi: 10.1097/00001756-200112040-00017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeev Friedman, M.D contact
Naveed Siddiqui, M.D principal investigator
Mount Sinai Hospital Department of Anesthesia and Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nabilone in people with Inflammatory Bowel Diseases, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naveed Siddiqui, M.D (416-586-4800 ext. 5270, naveed.siddiqui@uhn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of opioid consumption postoperatively (time frame: For up to 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422861, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.