Status:
TERMINATED
Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain
Lead Sponsor:
Santé Cannabis
Collaborating Sponsors:
Tetra Bio-Pharma
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Seeking for effective therapeutic strategies, the investigators are proposing to test the effectiveness of different formulations of medical cannabis oil to alleviate chronic pain, which was partially...
Detailed Description
This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate the safety and efficacy of different formu...
Eligibility Criteria
Inclusion
- Written informed consent
- Adult patients (older than 18 years of age), male and female, with chronic non-cancer and cancer pain (at least 3 months in duration)
- Patients experiencing an average weekly pain intensity score greater than 4 on a 11 points NRS
- Subject agreed to follow the protocol
- Naïve cannabis patients with chronic non-cancer and cancer pain (not used cannabis in any presentation in the last 12 weeks)
- Patients receiving opioids and other concomitant pain medications should have a stable dose for the last 15 days.
- Normal cognitive status according to MiniCog
- Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
- Normal renal function (defined as serum creatinine level \<133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60)
- Negative result on βhuman chorionic gonadotropin pregnancy test (if applicable)
- Ability to read and respond to questions in French or English.
- A female volunteer must meet one of the following criteria:
- If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose.
- If of non-childbearing potential - should be surgically sterile or in a menopausal state
- A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.
Exclusion
- Acute pain (less than 3 months in duration)
- Previous serious adverse event or hypersensitivity to cannabis or cannabinoids
- Inability to understand and comply with the instructions of the study
- Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
- Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
- Life-time history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM 5
- Life-time history of DSM 5 schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids
- Current or history of suicidal ideation
- Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception
- Hepatic impairment (aspartate aminotransferase more than three times normal) or renal function impairment (serum creatinine level \>133 µmol/L, Estimated Glomerular Filtration Rate (eGFR) \<60)
- Cognitive impairment according to MiniCog
- The patient is currently using or has used cannabinoid based medications within 90 days of study entry and is unwilling to abstain for the duration of the study
- Positive urine drug screen for cannabinoids and other potential abuse substances (e.g. alcohol, cocaine, amphetamines and methamphetamines, unprescribed opioids)
- Participation in another clinical trial within 30 days of enrolment in our trial
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2019
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT03337503
Start Date
January 29 2018
End Date
February 15 2019
Last Update
December 2 2024
Active Locations (1)
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1
Santé Cannabis
Montreal, Quebec, Canada, H2L 3K9