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Cannabinoid

CBD for Anxiety

Phase 2

Recruiting

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet diagnosis for moderate to severe anxiety based on a score of more than 14 in the Hamilton Anxiety Rating Scale (HAM-A)

Be between 18 and 65 years old

Must not have

Unstable medical or neurological condition

Severe depression symptoms in the past six months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the end of titration phase at 2 weeks (day 1 to day 14).

Summary

This trial will test the effects of a hemp-derived CBD product on anxiety and sleep in individuals with anxiety. Participants will take either CBD or a placebo for 4 weeks to see if it is safe and

Who is the study for?

Adults aged 18-55 with moderate to severe anxiety, as indicated by a HAM-A score over 14. Participants must be willing to give informed consent, follow study procedures including blood donation, and use two effective contraception methods if of childbearing potential.

What is being tested?

The trial is testing the safety and preliminary effectiveness of hemp-derived CBD for reducing anxiety symptoms and sleep disturbances. It's a randomized, double-blind study comparing CBD doses (50-150 mg/day) against placebo over four weeks.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but may include typical reactions associated with CBD such as fatigue, changes in appetite or weight, diarrhea, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My anxiety level is moderate to severe, according to the HAM-A scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable medical or neurological conditions.

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I have experienced severe depression symptoms in the last six months.

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I regularly use acetaminophen or topical antifungals more than twice a week.

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I have a history of or currently have liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the end of titration phase at 2 weeks (day 1 to day 14).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end of titration phase at 2 weeks (day 1 to day 14).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of titration phase at 2 weeks (day 1 to day 14). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+3 more

Secondary study objectives

Average of acceptability to study procedures score based on feasibility and acceptability study forms

Change in anxiety symptoms scores based on the Hamilton Anxiety Rating Scale.

Change in generalized anxiety symptoms and severity based on the Generalized Anxiety Disorder 7 scale

+4 more