Trials / Unknown
UnknownNCT03635593
Cannabis Oil for Chronic Non-Cancer Pain Treatment
Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 309 (estimated)
- Sponsor
- Hamilton Health Sciences Corporation · Academic / Other
- Sex
- All
- Age
- 26 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CBD | Participants will be randomized to CBD 10mg capsules for 12 weeks. Participants will start with 1, CBD (10mg) capsule per day and self-titrate up to 8, 10mg CBD capsules (80mg) per day as needed. |
| DRUG | CBD+THC | Participants will be randomized to CBD+THC 10mg (CBD 5mg + THC) for 12 weeks. Participants will start with 1, 10mg CBD+THC (5mg+5mg) capsule per day and self- titrate up to 8, 10mg CBD+THC (5mg+5mg) capsules to a maximum of 80mg (40mg CBD + 40mg THC) per day as needed. |
| OTHER | Placebo | Participants randomized to placebo 10mg capsules for 12 weeks. Participants will start with 1, 10mg placebo capsule per day and self-titrate up to 8 10mg placebo capsules (80mg) per day. |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2021-01-30
- Completion
- 2021-01-30
- First posted
- 2018-08-17
- Last updated
- 2018-11-13
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03635593. Inclusion in this directory is not an endorsement.