NCT05023759

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

Anxiety Symptoms in Relation to Use of Hemp-Derived, Full Spectrum Cannabidiol (CBD): a Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Formula30A LLC · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules	Formula30A Full Spectrum Hemp-Derived Cannabidiol (CBD) 25mg Capsules taken once daily for 8 weeks.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2021-08-27
• Last updated: 2021-08-27

Locations

6 sites across 2 countries: United States, Puerto Rico