NCT07123467 Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder
| NCT ID | NCT07123467 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Wayne State University |
| Condition | Generalized Anxiety Disorder (GAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2025-11-03 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Hilary Marusak, PhD
PRINCIPAL INVESTIGATOR
Wayne State University
Frequently Asked Questions
Who can join the NCT07123467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Generalized Anxiety Disorder (GAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07123467 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT07123467 currently recruiting?
Yes, NCT07123467 is actively recruiting participants. Contact the research team at hmarusak@med.wayne.edu for enrollment information.
Where is the NCT07123467 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT07123467 clinical trial?
NCT07123467 is sponsored by Wayne State University. The principal investigator is Hilary Marusak, PhD at Wayne State University. The trial plans to enroll 90 participants.
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