Cannabidiol for Reduction of Brain Neuroinflammation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMassachusetts General Hospital
About this trial
This study will investigate whether cannabidiol (CBD), the primary centrally and peripherally active non-intoxicating compound in the cannabis plant, exerts anti-neuroinflammatory effects in patients with chronic low back pain (cLBP) with or without mild-to-moderate depression.
Eligibility criteria
Qualifiers
Age ≥ 18 and ≤ 75;
The ability to give written, informed consent;
Fluency in English;
Average worst daily pain of at least 4 on a 0-10 scale of pain intensity, during a typical day. Pain needs to be present for at least 50% of days during a typical week;
Disqualifiers
Outpatient surgery within 2 weeks and inpatient surgery within 1 month of the time of scanning (this timeframe may be extended if they are not fully recovered from the surgery);
Elevated baseline transaminase (ALT and AST) levels above 3 times the Upper Limit of Normal (ULN), accompanied by elevations in bilirubin above 2 times the ULN;
Any interventional pain procedures within 6 weeks prior to scanning procedure or at any point during study enrollment;
Surgical intervention or introduction/change in opioid regimen at any point during study enrollment;
Trial design
Treatments tested in this trial
- CBD
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov