Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Wayne State University
Study ID
NCT07123467
Phase
PHASE3
Status
Recruiting
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Conditions

  • Anxiety Disorders
  • Generalized Anxiety Disorder (GAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-Dose Cannabidiol — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

This randomized, double-blind, placebo-controlled clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD). The study aims to evaluate whether cannabidiol-assisted CBT enhances emotion regulation via dorsomedial prefrontal cortex (dmPFC) activation and improves anxiety symptom outcomes compared to CBT with placebo.

Key Dates

Start date
Nov 3, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brief Cognitive Behavioral Therapy + Moderate-Dose Cannabidiol
    Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with oral cannabidiol (EPIDIOLEX®) at a moderate dose. Dosing starts at 5 milligram/kilogram/day and titrates to 10 milligram/kilogram/day (divided twice a day) after 6 days. Cannabidiol is administered chronically throughout CBT to examine target engagement and symptom outcomes.
  • Experimental: Brief Cognitive Behavioral Therapy + Low-Dose Cannabidiol
    Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a lower dose of oral cannabidiol (EPIDIOLEX®), maintained at 5 milligram/kilogram/day (divided twice a day) throughout the treatment period. No titration is required.
  • Placebo Comparator: Brief Cognitive Behavioral Therapy + Placebo Titrated to Match Moderate-Dose Cannabidiol
    Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a matched placebo oral solution. The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the moderate dose cannabidiol arm, dosing starts at 5 milligram/kilogram/day and titrates to 10 milligram/kilogram/day (divided twice a day) after 6 days.
  • Placebo Comparator: Brief Cognitive Behavioral Therapy + Placebo Titrated to Match Low-Dose Cannabidiol
    Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a matched placebo oral solution. 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.

Primary Outcome Measure

Change in dorsomedial prefrontal cortex activation when reappraising negative images [ Time Frame: Baseline to post-treatment (~Week 5) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wayne State University School of Medicine, Tolan Park Medical BuildingDetroitMichigan48201
Hilary Marusak, PhD
[email protected]
(313) 577-1278
Leslie Lundahl, PhD
[email protected]
(313) 993-1374
Hilary Marusak, PhD (PRINCIPAL_INVESTIGATOR)
Leslie Lundahl, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Wayne State University School of Medicine, Tolan Park Medical Building· Detroit, MI

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