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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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)
. 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