Clinical trial NCT03635593: Cannabis Oil for Chronic Non-Cancer Pain Treatment
Official title: Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Non-cancer Pain
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 309
Sex: ALL
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Average Pain Score
timeFrame: 12 weeks after Treatment (Week 16 of trial)
Secondary outcomes:
measure: Pain Severity Score
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Pain Intensity Score
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Physical Functioning Score
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Mental Health Score
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Social Functioning Score
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Physical Health-related Role Limitations
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Depression Score
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Anxiety Score
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Sleep Quality
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Pain Medication
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Other non-pain prescription medications
timeFrame: Baseline, week 4, 8, 12 and 16
measure: Average Pain Score
timeFrame: Baseline, week 4, 8 and 12
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Michael G. DeGroote Pain Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Poly Clinic
state: Ontario
Study officials:
References: