A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This open-label to double-blind study evaluates the impact of cannabidiol (CBD) on anxiety in adults. Participants will use a custom-formulated sublingual (under-the-tongue) solution of whole plant, hemp-derived CBD twice daily for six weeks in addition to their normal treatment regimen. Participants' clinical state will be assessed weekly during the treatment period. Quality of life, sleep, general health, and cognitive function will also be assessed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Treatments: Epidiolex; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Subject has provided informed consent

• Subject is 18 or older

• Subject is a native English speaker or acquired English prior to age 5

• Subject endorses moderate or severe anxiety at the screening visit

Exclusion Criteria:

• Non-native English speakers

• Estimated IQ < 75

• Current substance abuse/dependence, psychotic disorder, bipolar disorder, or an eating disorder

• A history of head injury or loss of consciousness greater than 5 minutes

• Currently uses marijuana or cannabinoid-based products more frequently than 1x/month

• Female subjects will be excluded if they have a positive urine pregnancy test, or if they are currently breastfeeding

• Presence of a serious medical illness, including liver or kidney disease, or neurological disorder

• Allergy to coconut oil

• Current use of valproate

• Additional exclusions related to MR imaging, including claustrophobia, metal implanted within the body, etc.