Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Generalized Anxiety Disorder (GAD)Anxiety Disorders
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (2)

48201

Wayne State University Eugene Applebaum College of Pharmacy & Health Sciences, Detroit

Wayne State University School of Medicine, Tolan Park Medical Building, Detroit

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Wayne State University

OTHER