Health TrialsbyHealthPanel

Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

ConditionsGeneralized Anxiety Disorder (GAD)Anxiety Disorders
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-45
SponsorWayne State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Right-handed

Age 18-45 years at enrollment

Able to consent to the study

Agree to adhere to lifestyle considerations throughout study duration

Disqualifiers

Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol

Any current (or within past 2 months) medical condition requiring medication that would interact with cannabidiol or interfere with the study protocol

Risk of harm to self or others that requires immediate intervention

Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances or components of EPIDIOLEX®

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 4 treatment groups
Group A: Brief Cognitive Behavioral Therapy + Moderate-Dose CannabidiolExperimental treatment 1 intervention
Group B: Brief Cognitive Behavioral Therapy + Low-Dose CannabidiolExperimental treatment 1 intervention
Group C: Brief Cognitive Behavioral Therapy + Placebo Titrated to Match Moderate-Dose CannabidiolPlacebo comparator 1 intervention
Group D: Brief Cognitive Behavioral Therapy + Placebo Titrated to Match Low-Dose CannabidiolPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in dorsomedial prefrontal cortex activation when reappraising negative images

Within-participant change in dorsomedial prefrontal cortex (dmPFC) activation will be calculated as post-treatment minus baseline values during an explicit emotion regulation task (Reappraise \> Maintain contrast). Measured using blood-oxygen-level-dependent (BOLD) signal from multi-echo functional magnetic resonance imaging (fMRI).

Time frame
Baseline to post-treatment (~Week 5)

Secondary outcomes

1

Post-treatment dorsomedial prefrontal cortex activation when reappraising negative images

Post-treatment dorsomedial prefrontal cortex (dmPFC) activation during an explicit emotion regulation task (Reappraise \> Maintain contrast). Measured using blood-oxygen-level-dependent (BOLD) signal from multi-echo functional magnetic resonance imaging (fMRI).

Time frame
Post-treatment (~Week 5)
2

Post-treatment amygdala activation when reappraising negative images

Post-treatment amygdala activation during an explicit emotion regulation task (Reappraise \> Maintain contrast). Measured using blood-oxygen-level-dependent (BOLD) signal from multi-echo functional magnetic resonance imaging (fMRI).

Time frame
Post-treatment (~Week 5)
3

Change in amygdala activation when reappraising negative images

Within-participant change in amygdala activation will be calculated as post-treatment minus baseline values during an explicit emotion regulation task (Reappraise \> Maintain contrast). Measured using blood-oxygen-level-dependent (BOLD) signal from multi-echo functional magnetic resonance imaging (fMRI).

Time frame
Baseline to post-treatment (~Week 5)
4

Post-treatment hippocampal activation when reappraising negative images

Post-treatment hippocampal activation during an explicit emotion regulation task (Reappraise \> Maintain contrast). Measured using blood-oxygen-level-dependent (BOLD) signal from multi-echo functional magnetic resonance imaging (fMRI).

Time frame
Post-treatment (~Week 5)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayne State University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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