Cannabis Oil for Chronic Non-Cancer Pain Treatment
Unknown statusPhase 2NCT03635593
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Brief summary (from the registry)
Cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. The cannabis plant (Cannabis sativa, Cannabis indica) consists of several hundred compounds of which, approximately 70 of which are thought to be active. The two active cannabinoids of interest in this trial are tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). The goal of this trial is to determine whether CBD or CBD+THC reduces the average pain in participants with chronic non-cancer pain. The investigators also aim to determine whether CBD or CBD+THC is associated with a reduction in pain severity, pain interference, anxiety, depression, insomnia, opioids and use of benzodiazepines, analgesics, antidepressants, anxiolytics, or hypnotics amongst chronic non-cancer pain patients or an increase in physical functioning, physical health related role limitations, social functioning, mental functioning.
Study details
- Official title
- Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial
- Conditions
- Chronic Non-cancer Pain
- Interventions
- Drug: CBD
- Drug: CBD+THC
- Other: Placebo
- Sponsor
- Hamilton Health Sciences Corporation
- Start date
- 2019-01-01
- Primary completion
- 2021-01-30
- Sex
- All
- Age range
- from 26 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age \>25 * Average pain score in past week of ≥ 4/10. Exclusion Criteria: * Personal history of bipolar disorder * Personal or family history (first degree relative - parent of sibling) of psychotic disorders (e.g., schizophrenia) * Active cancer (an individual undergoing active cancer chemotherapy, radiation or surgical treatment and is deemed to not be in remission as per an oncologist's report) * Intention to travel internationally during the trial * Uncontrolled diabetes (A1C \> 11) * Cannabis use in the past 4 weeks (recreational or medicinal) * Current use of illicit drugs (e.g., cocaine) * Current use of non-prescription opioids * Unable to read and write in English * Women who are currently pregnant or breast-feeding; or women of child-bearing age who plan to become pregnant during the trial period.
Canadian sites (2)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03635593