Active — Not RecruitingPhase 2

Use of CBD in the Treatment of Anxiety

United States30 participantsStarted 2025-01-06

Plain-language summary

This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 datab…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average CBD dose (mgs) used in the titration phase as reported in participant forms.

Timeframe: From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14).

Average CBD dose (mgs) used in the maintenance phase as indicated and reported in participant forms.

Timeframe: From week 2 to the end of maintenance phase at 4 weeks (Day 15 to Day 28)

Percentage of Severity of treatment-related adverse events based on the side effects/adverse events checklist, laboratory test, and self-report of unexpected ADE

Timeframe: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84)

Percentage of patients reporting Drug-Induced Liver Injury based on liver chemistries

Timeframe: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).

Percentage of severity of depression symptoms based on the Patient Health Questionnaire-9

Timeframe: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).

Percentage of participants reporting suicidal ideation and behavior based on the Columbia Suicide Severity Rating Scale

Trial details

NCT IDNCT06672666

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

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