Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
309 participants
INTERVENTIONAL
2019-01-01
2021-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improving Pain Disability With the Use of Oral Cannabinoids
NCT05351905
Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain
NCT03337503
Cannabis for Opioid Substitution Trial
NCT03859089
Cannabis Oil for Pain Effectiveness
NCT03522467
Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)
NCT03215940
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CBD
10mg capsules Cannabidiol (CBD)
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.
CBD+THC
10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC)
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.
Placebo
10mg capsules placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Average pain score in past week of ≥ 4/10.
Exclusion Criteria
* 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.
26 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hamilton Health Sciences Corporation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ramesh Zacharias
Medical Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Michael G. DeGroote Pain Clinic
Hamilton, Ontario, Canada
Toronto Poly Clinic
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MGD-011-20180805
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.