Sublingual Cannabidiol for Anxiety

IRB Approval #2015P000959

The clinical trial we are currently recruiting for is designed to examine the impact of cannabidiol on anxiety over the course of four weeks. The study involves a total of five visits to the hospital. If eligible for the clinical trial, you will be assigned by chance to the cannabidiol group or the placebo group. Study staff will not know which group you have been assigned to, but you will have a higher chance of being assigned to the cannabidiol group.

The first visit is conducted prior to initiating treatment with cannabidiol or placebo, and involves completing questionnaires, paper-and-pencil tasks, buccal (cheek) swab for DNA analysis, and a clinical interview as well as an optional MRI scan and/or optional blood draw; this visit lasts about 5-6 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 four weeks of treatment, and includes additional questionnaires, and paper-and-pencil tasks as well as another optional MRI scan and/or optional blood draw; this visit lasts about 3-4 hours. The majority of these visits can be completed remotely, from your home.

You can earn up to $350 for participating in the study - $75 for completing the first visit, $50 each for the second, third, and fourth visits, $75 for the fifth visit, and a $50 bonus for completing all visits. If eligible, you can earn an additional $150 for completing MRI scans and an additional $50 for completing blood draws at the first and fifth 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. Pregnancy
  4. Current use of cannabis or cannabinoid products
Location
McLean Hospital in Belmont, MA
State
MA
Study End Date

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