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New treatment option for Generalized Anxiety Disorder (GAD)
Official title Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT07123467
What this study is testing
What is Low-Dose Cannabidiol?
Low-Dose Cannabidiol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for generalized anxiety disorder (gad).
Also referred to as EPIDIOLEX®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- 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
You likely can't join if
- Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or...
- 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...
- Positive drug screen or alcohol breathalyzer
- Unwilling/unable to sign informed consent document
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.