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

IRB Protocol #: 2019P003885IRB 

The clinical trial we are currently recruiting for is designed to examine the impact of a hemp-derived cannabidiol product on anxiety over the course of six weeks. The study involves a total of seven visits to the hospital, the majority of which can be completed remotely. The first visit is conducted prior to initiating treatment with cannabidiol and involves completing questionnaires, paper-and-pencil tasks, a buccal (cheek) swab for DNA analysis, a clinical interview, and an optional MRI scan; this visit lasts about 6 hours. Subsequent visits occur weekly throughout the treatment period and include questionnaires and a check-in with study staff; these visits last about 1 hour. The final visit occurs after six weeks of treatment and includes additional questionnaires, paper-and-pencil tasks, and another optional MRI scan; this visit lasts about 4 hours.

You can earn up to $350 for participating in the study - $75 for completing the first visit, $30 each for visits two through six, $75 for the seventh visit, and a $50 bonus for completing all visits. If eligible, you can earn an additional $150 for completing MRI scans at the first and seventh visits.

We typically conduct these visits Monday-Friday between 9am and 5pm. This study takes place at the McLean Hospital Brain Imaging Center in Belmont, MA (http://www.mclean.harvard.edu/about/directions/)

Organization
McLean Hospital, Harvard Medical School
Principal Investigator
Dr. Staci Gruber
Eligibility Criteria
  1. Provides informed consent
  2. 18 or older
  3. Native English speaker or acquired English prior to age 5
  4. Endorses moderate or severe anxiety at the screening visit
Exclusion Criteria
  1. Presence of serious medical illness, including liver or kidney disease, neurological disorder, or certain psychiatric disorders
  2. History of head injury or loss of consciousness >5 minutes
  3. Currently pregnant or breastfeeding
  4. Current use of cannabis or cannabinoid products
  5. Allergy to coconut oil 
  6. Current use of valproate
Location
McLean Hospital in Belmont, MA
State
MA
Study End Date

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