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

NCT04286594 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2019P003885
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)

  The BAI is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 to 3, and will be given to participants on a weekly basis. The possible range of scores is 0-63.

  6 weeks

Study Arms (1)

CBD

EXPERIMENTAL

0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks.

Drug: CBD

Interventions

CBD DRUG

Participants will receive CBD solution during the open-label phase of the trial.

CBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Staci Gruber
• Organization: McLean Hospital

gruber@mclean.harvard.edu

617-855-2762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: February 1, 2021
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: August 27, 2024
• Results First Posted: August 27, 2024

Record last verified: 2024-08

Locations

US (1)