Could CBD be the next frontier for anxiety relief?
NCT ID NCT06672666
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study investigates whether a hemp-derived cannabidiol (CBD) extract can safely reduce anxiety and improve sleep in adults with moderate to severe anxiety. Over four weeks, participants take 50 to 150 mg of CBD daily, with doses adjusted based on tolerance. The trial tracks side effects, liver health, and changes in anxiety and sleep symptoms to determine the best dosing strategy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hemp-derived cannabidiol (CBD) extract
- What this could lead to
- If it works, this could point toward a natural, plant-based option for managing anxiety and sleep issues with fewer side effects than standard medications.
- What could go wrong
- This is a small, early-phase pilot study with only 30 participants. It is designed to test safety and dosing, not to prove effectiveness. CBD can cause side effects like drowsiness or liver issues, and results may not apply to everyone.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Any biological sex and ages 18 to 55 years old * Willing and able to give informed consent for participation in the study * Willing and able to comply with all study requirements, including willingness to donate blood during the study * Meet diagnosis for moderate to severe anxiety based on a score of more than 14 in the Hamilton Anxiety Rating Scale (HAM-A) * Subjects of childbearing potential should use two forms of highly effective contraception methods combined (e.g., barrier methods combined with Long-Acting Reversible Contraceptives) to be eligible for study participation. * Normal clinical history and laboratory test Exclusion Criteria: * Pregnancy or breastfeeding * Any history of suicidal behavior or any suicidal ideation in the past six months or at screening * Any change in current SSRI, SNRI, or other non-benzo anxiolytic medication within six weeks of baseline visit. * Active daily or almost daily (3+ days/week) use of cannabinoids or THC in the past month or any other illicit drug within the past 6 months * Inability to refrain from using alcohol (4 or more drinks in one occasion or 3+ days/week), antiepileptics, antipsychotics, oral antifungals, verapamil, nitrofurantoin, or any other medication in drug classes, such as antibiotics, nonsteroidal anti-inflammatory drugs, herbal and dietary supplements, cardiovascular drugs, central nervous system agents, or antineoplastic drugs, inducing transaminase elevation based on the LiverTox database. 17,18 * Inability to adjust the doses of prescription medications displaying a narrow therapeutic index that are potentially impacted by concomitant cannabinoid use18,19. * Inability to refrain from using acetaminophen, or topic antifungals on a regular basis (more than two times per week) over the course of the trial. * Active use of benzodiazepines, opioids, and antihistamines or any other medication inducing lethargy and sedation, except for antidepressants, for which detailed information will be collected. * History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries at baseline (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) \>2 times ULN (or the baseline value if baseline is elevated); Total serum bilirubin \>2.5 mg/dL with elevated AST, ALT or ALP; or International normalized ratio (INR) \>1.5 with elevated AST, ALT or ALP).20 * Current substance use disorder * Unstable medical or neurological condition * Positive drug screen for substances of abuse * Lifetime history of psychotic disorder, bipolar disorder, PTSD or OCD * Psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. Subjects established in psychotherapy without change during the course of the study may participate. * Severe depression symptoms in the past six months. * Known or suspected hypersensitivity to cannabidiol or any other components in the extract.
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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.
Contacts and locations
Locations
-
University of Florida
Gainesville, Florida, 32611, United States
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