Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03422861
• Other study ID #: NAB-2017
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: Naveed Siddiqui, M.D
• Phone: 416-586-4800
• Email: naveed.siddiqui[@]uhn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' Global Impression of Change (PGIC)	The changes(if any) in Activity Limitations, Symptoms, Emotions and overall quality of life	Measured at baseline and 72 hours
Other	Incidence of depression	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
Other	Incidence of psychotropic adverse reactions of Nabilone using a questionnaire	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
Other	Incidence of suicide	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
Primary	Total amount of opioid consumption postoperatively	All the narcotic consumption will be converted to IV morphine equivalents using standard conversation factors	For up to 72 hours after surgery
Secondary	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	Starting from discharge from post-anesthetic care unit (PACU), twice a day for 72 hours
Secondary	Incidence of opioid related side effects	Based on Opioid-Related Symptom Distress Scale	Measured at 24, 48 and 72 hours
Secondary	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 at 24, 48, 72 hours
Secondary	Ulcerative Colitis (UC) symptom severity	Based on Simple Clinical Colitis Activity Index (SCCAI)	Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Secondary	Crohn disease (CD) symptom severity	Based on Harvey-Bradshaw Index (HBI)	Measured at baseline (pre-anesthetic clinic) and at 72 hrs
Secondary	Time to first flatus	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
Secondary	Number of loose stools	Predominantly watery/non-formed stool. Bristol stool chart type 6 and 7	Measured on a daily basis for up to 72 hrs after surgery
Secondary	Length of hospital stay	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