Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Wayne State University · Other
Who this trial is looking for
This trial is looking for adults with generalized anxiety disorder (GAD) who want to try cannabidiol with cognitive behavioral therapy (CBT). Participants will need to meet certain health criteria and take part in different study sessions.
Are You a Good Fit for This Trial?
Rules you outBipolar disorderSchizophreniaSevere alcohol use disorder
You may be able to join if
I am aged 18-45 years old.
I can give my consent to join the study.
I have been diagnosed with generalized anxiety disorder (GAD).
I am generally healthy and without serious cognitive issues.
I am right-handed.
I agree to follow lifestyle guidelines during the study.
You may not be able to join if
I have a medical or neurological condition that affects my ability to participate.
I am currently pregnant or planning to become pregnant.
I have current or past substance use disorders.
I have had a traumatic brain injury.
I cannot tolerate small, enclosed spaces without anxiety.
I have any known allergy to cannabinoid products.
I have used cannabis or THC products in the past month.
I do not agree to follow the study's instructions.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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) activatio…
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.
Trial Locations
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Status
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 impairmen…
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.
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