Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain (NCT03337503) | Clinical Trial Compass
TerminatedPhase 2
Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain
Stopped: Sponsor decision to stop the study
Canada161 participantsStarted 2018-01-29
Plain-language 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 relieved with conventional prescriptions. Furthermore, the investigators would like to assess the effect of different formulations of medical cannabis oil on other symptoms associated to chronic pain like anxiety and depression, as well as insomnia and appetite. Finally, as recently recommended for clinical studies on medical cannabis, the investigators will examine the safety profile of different cannabis formulations focusing on the following elements: a real chronic administration with more than two weeks of treatment, a larger number of patients, and the clinical relevance of medical cannabis oil to change the amount and type of concomitant medications used to control chronic non-cancer and cancer pain.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. Acute pain (less than 3 months in duration)
What they're measuring
1
Does the daily use of cannabis oil improves chronic pain
Timeframe: Change from Baseline in BPI-SF at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
2
Does the daily use of cannabis oil improves chronic pain
Timeframe: Change from Baseline in NRS at Weeks 1 and 6 and in follow-up phase at Weeks 10 and 18.
. 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