Cannabis Oil for Chronic Non-Cancer Pain Treatment (CONCEPT)

Hamilton Health Sciences (HHS)

Status and phase: Unknown; Phase 2

Conditions: Chronic Non-cancer Pain

Treatments: Drug: CBD+THC; Drug: CBD; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03635593

MGD-011-20180805

Details and patient eligibility

About

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.

Enrollment: 309 estimated patients

Sex: All

Ages: 26+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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309 participants in 3 patient groups, including a placebo group

CBD

Active Comparator group

Description:

10mg capsules Cannabidiol (CBD)

Treatment:

Drug: CBD

CBD+THC

Active Comparator group

Description:

10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC)

Treatment:

Drug: CBD+THC

Placebo

Placebo Comparator group

Description:

10mg capsules placebo

Treatment:

Other: Placebo