90
Participants
Start Date
October 1, 2025
Primary Completion Date
August 31, 2027
Study Completion Date
August 31, 2027
Low-Dose Cannabidiol
Oral cannabidiol solution (EPIDIOLEX®) administered as an adjunct to cognitive behavioral therapy. Low-dose participants receive 5 milligram/kilogram/day throughout. The intervention targets emotion regulation circuitry and symptom improvement.
Placebo Matched to Moderate-Dose Cannabidiol
The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the moderate-dose cannabidiol arm, dosing starts at 5 mg/kg/day and titrates to 10 milligram/kilogram/day (divided twice a day) after 6 days.
Moderate-Dose Cannabidiol
Oral cannabidiol solution (EPIDIOLEX®) administered as an adjunct to cognitive behavioral therapy. Moderate-dose participants receive 5 milligram/kilogram/day for 6 days, then titrate to 10 milligram/kilogram/day. The intervention targets emotion regulation circuitry and symptom improvement.
Placebo Matched to Low-Dose Cannabidiol
The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the low-dose cannabidiol arm, dosing is maintained at 5 milligram/kilogram/day (divided twice a day) throughout the treatment period. No titration is required.
Wayne State University Eugene Applebaum College of Pharmacy & Health Sciences, Detroit
Wayne State University School of Medicine, Tolan Park Medical Building, Detroit
National Institute of Mental Health (NIMH)
NIH
Wayne State University
OTHER