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Cannabidiol-Assisted Learning for Generalized Anxiety Disorder

This study is testing if EPIDIOLEX® (an FDA-approved cannabidiol solution) can help adults with Generalized Anxiety Disorder (GAD) when combined with cognitive behavioral therapy (CBT). Researchers want to see if EPIDIOLEX® helps improve how your brain regulates emotions and reduces anxiety symptoms. You might receive a low dose of EPIDIOLEX®, a moderate dose, or a placebo (an inactive substance that looks and tastes like EPIDIOLEX®). The study is looking for 90 right-handed participants between 18 and 45 years old who have a GAD diagnosis and are generally healthy. The main goal is to see changes in a specific brain area (dorsomedial prefrontal cortex) that helps with emotion regulation after about five weeks of treatment. The current status of this study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study with 90 planned participants. Participants will be assigned to one of four groups: low-dose EPIDIOLEX®, moderate-dose EPIDIOLEX®, or one of two placebo groups.
What's involved
Participants will receive oral EPIDIOLEX® or placebo as an add-on to cognitive behavioral therapy. The study involves assessments from baseline to about Week 5.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from baseline to post-treatment, which is around Week 5.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07123467

Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

Recruiting
PHASE3Ages 18–45InterventionalTreatment
Wayne State University
~90 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:Low-Dose CannabidiolPlacebo Matched to Moderate-Dose CannabidiolModerate-Dose CannabidiolPlacebo Matched to Low-Dose Cannabidiol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in dorsomedial prefrontal cortex activation when reappraising negative images
Measured over Baseline to post-treatment (~Week 5)

Conditions

Generalized Anxiety Disorder (GAD)
Anxiety Disorders

Explore related trials

Generalized Anxiety Disorder

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Hilary Marusak, PhD · PRINCIPAL_INVESTIGATOR · Wayne State University
  • Christine Rabinak, PhD, MBA · PRINCIPAL_INVESTIGATOR · Wayne State Universty
  • Leslie Lundahl, PhD · PRINCIPAL_INVESTIGATOR · Wayne State University

Who to contact

Hilary Marusak, PhD
[email protected]
(313) 577-1278
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Right-handed
Age 18-45 years at enrollment
Able to consent to the study
Agree to adhere to lifestyle considerations throughout study duration
Generally medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment
Have a current generalized anxiety disorder (GAD) diagnosis according to the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and/or total scores ≥ 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7)

Exclusion

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®
Positive drug screen or alcohol breathalyzer
Unwilling/unable to sign informed consent document
Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women),
Under 18 or over 45 years of age
Traumatic brain injury, as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and/or the brain undergoing an acceleration/deceleration movement \[i.e., whiplash\] without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient)
Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and/or a preliminary session in a mock scanner
Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
Receiving concurrent psychotherapy or have received psychotherapy, including for research purposes, within the past year
Current moderate or severe alcohol/drug use disorder or in the past 8 weeks
Current or past diagnosis of bipolar and other related disorders, schizophrenia spectrum, or other psychotic disorders;
GAD-7 score \< 8
Use of medications known to have severe drug interactions with cannabidiol or that are strong inducers of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19)
Visual impairment
Baseline labs 3 times outside of normal range
Use of as needed anti-anxiety medications (e.g., benzodiazepines), unstable dose of other psychoactive drug (i.e., \< 4 weeks), or intention to start new treatment during this trial
Current or past-month use of cannabis, or a tetrahydrocannabinol (THC) or cannabidiol-containing product (self-report and urine drug screen)
Current or past-month coronavirus disease 2019 (COVID-19) diagnosis or febrile illness
Treatment with another investigational drug or intervention within the past month
Difficulty with or inability to comply with the complete clinical trial.

What this trial measures

  • Change in dorsomedial prefrontal cortex activation when reappraising negative imagesBaseline to post-treatment (~Week 5)

    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).