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NCT06672666

Use of CBD in the Treatment of Anxiety

Active, Not Recruiting
PHASE2Ages 18–55InterventionalTreatment
University of Florida
~30 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Hemp Derived Cannabidiol ExtractPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average CBD dose (mgs) used in the titration phase as reported in participant forms.
Measured over From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14).
+5 more outcomes measured

Conditions

Anxiety
Generalized Anxiety Disorder
Sleep Problems

Explore related trials

Generalized Anxiety Disorder

Where it's being run

1 sites across 1 states
Florida1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Average CBD dose (mgs) used in the titration phase as reported in participant forms.From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14).

    This trial will inform the dosing of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract (from 50 to 150 mg/day of CBD) among individuals with anxiety. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires will be used to examine adherence to dosing protocol and potential changes due to side effects. During the titration phase, participants will be instructed to use an initial dosing of 50 mg/day in the morning progressively increasing 50 mg CBD/day before bedtime as tolerated by the individual participant, up to 150 mg/day by day 14. If a patient experiences mild side effects at doses at or higher than 50 mg daily, the investigators will monitor and may consider temporarily or permanently reducing the dose for the remainder of the study to the doses tolerated. Participants will report the daily doses used on a weekly basis in a dosing sheet.

  • Average CBD dose (mgs) used in the maintenance phase as indicated and reported in participant forms.From week 2 to the end of maintenance phase at 4 weeks (Day 15 to Day 28)

    This trial will inform the dosing of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract (50 to 150 mg/day of CBD) among individuals with anxiety. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires will be used to examine adherence to dosing protocol and potential changes due to side effects. During the maintenance phase, participants will stay at the optimal tolerated dose (between 50-150 mg) for two additional weeks. If a patient experiences mild side effects at doses at or higher than 50 mg daily, the investigators will monitor and may consider temporarily or permanently reducing the dose for the remainder of the study to the doses tolerated. Participants will report the daily doses used on a weekly basis in a dosing sheet.

  • Percentage of Severity of treatment-related adverse events based on the side effects/adverse events checklist, laboratory test, and self-report of unexpected ADEFrom enrollment to the end of the study period at 12 weeks (Day 1 to Day 84)

    The safety and tolerability will be determined in eight-assessments conducted during a 12-week period, and based on the side effects/adverse events checklist, laboratory tests, and self-reports of unexpected adverse drug events (ADEs). The type of treatment-related adverse events based will be characterized based on those assessments. The side effects/adverse events will be categorized as: no ADEs, mild (i.e., no intervention required; no impact on activities of daily living), moderate (minimal, local, or non-invasive intervention indicated; moderate impact on activities of daily living) or severe (i.e., significant symptoms requiring invasive intervention; subject seeks medical attention, needs major assistance).

  • Percentage of patients reporting Drug-Induced Liver Injury based on liver chemistriesFrom enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).

    In this study, patients are going to be followed for 84 days after treatment initiation, with serum liver chemistries assessments at baseline, and in four subsequent visits (visits 3, 5, 6 and 8), with the last serum liver chemistries 49 days after the last doses. The result is reported as the number of participants that had a clinically significant clinically significant elevation in serum liver chemistries (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) \>2 times ULN, 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.

  • Percentage of severity of depression symptoms based on the Patient Health Questionnaire-9From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).

    The Patient Health Questionnaire-9 is a 9-item scale useful for the assessment of the presence and severity of depressive symptom, and a possible depressive disorder. Each of the nine items reflects a DSM-5 symptom of depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

  • Percentage of participants reporting suicidal ideation and behavior based on the Columbia Suicide Severity Rating ScaleFrom enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).

    The Columbia Suicide Severity Rating Scale (C-SSRS) is a 6-item scale that assesses suicidal ideation and behavior by helping to identify specific behaviors that may be indicative of an individual's intent to kill oneself. Four constructs are measured, including: severity of ideation, intensity of ideation, behavior and lethality.