RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Low-Dose Cannabidiol for Generalized Anxiety Disorder (GAD)

This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment 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 dummy treatment (placebo).

Official registry: https://clinicaltrials.gov/study/NCT07123467 · Wayne State University · enrollment listed as 90

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Low-Dose Cannabidiol, Placebo Matched to Moderate-Dose Cannabidiol, or Moderate-Dose Cannabidiol. The registry lists allocation as randomized. This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment 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).

They plan to enroll about 90 people at Detroit. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder

Interventions: Low-Dose Cannabidiol, Placebo Matched to Moderate-Dose Cannabidiol, Moderate-Dose Cannabidiol, Placebo Matched to Low-Dose Cannabidiol

Primary outcome (registry wording): Change in dorsomedial prefrontal cortex activation when reappraising negative images

Who it is for (from inclusion criteria)

Ages 18 Years to 45 Years
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)

Who the registry excludes

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
Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women),
Under 18 or over 45 years of age

Public study contact (from the registry)

Hilary Marusak, PhD

(313) 577-1278

hmarusak@med.wayne.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Wayne State University School of Medicine, Tolan Park Medical Building — Detroit, Michigan (recruiting)

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FAQ about this NCT record

Is NCT07123467 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07123467?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07123467?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary