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NCT05023759 · ClinicalTrials.gov registry record

Anxiety Symptoms in Relation to Use of Hemp-derived, Full Spectrum Cannabidiol (CBD)

A clinical trial, sponsored by Formula30A.

Completed
Registry status
30
Enrollment target

NCT05023759: Completed study, sponsored by Formula30A.

NCT05023759 is a clinical trial that has completed, run by Formula30A. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05023759 has completed, sponsored by Formula30A.

COMPLETED
Registry status
30 participants
Enrollment target

Study Summary

Generalized anxiety disorder affects about 6.8 million adults in the United States, therefore its treatment is of major public health interest. Cannabidiol (CBD) has shown promise as an effective treatment for anxiety-related symptoms while lacking the severity of adverse effects seen with other medications. Given the wide availability of products containing CBD on the market today, from tinctures to coffee additives, and the undetermined potential for drug-to-drug interactions, medical supervision of CBD intake and formulation-specific clinical research is necessary. Therefore this study aimed to observe the effects of a specific hemp-derived full spectrum CBD formula on anxiety-related symptoms in a group of volunteers. The investigators will examine the self-reported anxiety symptoms in relation to use of a specific CBD formulation (25mg solvent-free full spectrum CBD capsules) in a cohort of adults diagnosed with generalized anxiety disorder. This open-label, cohort study will be conducted at six clinic sites in the United States (including Puerto Rico) from June 2020 through October 2020. The six physicians recruited to participate in the study were each actively prescribing CBD in their practices and were actively caring for patients with anxiety symptoms. Anxiety levels will be measured in enrolled participants diagnosed with generalized anxiety disorder each week for a period of eight weeks using the Generalized Anxiety Disorder 7-Item Scale (GAD7). Participants will also be instructed to take a daily 25mg capsule of CBD. The investigators hypothesize that this formula, when carefully developed and administered by a healthcare professional, will significantly reduce anxiety symptoms.

Primary Outcome

The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluat

Interventions

  • DIETARY_SUPPLEMENT Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2020-06-01
Est. Completion 2020-10-31
Formula30A

2 total trials

What the finished NCT05023759 record still lists

NCT05023759 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules is the first listed.

NCT05023759 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05023759 about?

NCT05023759 is a clinical study titled "Anxiety Symptoms in Relation to Use of Hemp-derived, Full Spectrum Cannabidiol (CBD)". Generalized anxiety disorder affects about 6.8 million adults in the United States, therefore its treatment is of major public health interest. Cannabidiol (CBD) has shown promise as an effective treatment for anxiety-related symptoms while lacking the severity of adverse effects seen with other med...

What is the current status of trial NCT05023759?

This trial is currently completed. The enrollment target is 30 participants. The study started on 2020-06-01. Estimated completion is 2020-10-31.

What interventions are being tested in trial NCT05023759?

The interventions under investigation include: Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05023759?

This trial is sponsored by Formula30A, which has 2 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05023759, the US trial registry maintained by the National Library of Medicine. NCT05023759 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.