CBD boosts talk therapy for anxiety? new trial investigates
NCT ID NCT07123467
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is testing whether adding a low or moderate dose of FDA-approved cannabidiol (Epidiolex) to cognitive behavioral therapy (CBT) helps adults with generalized anxiety disorder more than CBT plus a placebo. Researchers will measure changes in brain activity related to emotion regulation and anxiety symptoms. The trial enrolls 90 adults aged 18-45 who are generally healthy and have a current GAD diagnosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cannabidiol (Epidiolex)
- What this could lead to
- If successful, this could point toward a new way to boost the effects of talk therapy for anxiety, potentially helping people feel better faster or with fewer sessions.
- What could go wrong
- This is still an early-stage Phase 3 trial with only 90 participants, so results may not apply to everyone. The improvement in brain activity measured by fMRI may not translate to noticeable real-world benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wayne State University School of Medicine, Tolan Park Medical Building
RECRUITINGDetroit, Michigan, 48201, United States
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- Can the right electric pulse calm chronic worry?