Summary

Eligibility
for females ages 18-40 (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Guido K Frank, MD (ucsd)
Photo of Guido K Frank
Guido K Frank

Description

Summary

No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established. The current study is an important first step in the investigation of CBD for AN. Cannabis products have been recently legalized in many states, and CBD in particular has been shown to reduce anxiety. Therefore, CBD may represent a promising new treatment for AN. The endocannabinoid system is involved in the regulation of functions relevant to eating disorders. Furthermore, data suggest that eating disorders are associated with alterations of the endocannabinoid system. Prior attempts to target the endocannabinoid system in AN have focused on CB1 receptor agonists that can increase anxiety. Moreover, CBD may be particularly beneficial in decreasing anxiety in AN via its action at serotonin receptors. Lastly, the impact of CBD on eating behavior and weight in AN must be determined. The current study seeks to explore these hypotheses using the aims in the following section.

Official Title

The Role of Cannabidiol in Regulating Meal Time Anxiety in Anorexia Nervous: Safety, Tolerability and Pharmacokinetics

Keywords

Anorexia Nervosa Anorexia Cannabidiol Cannabidiol (CBD)

Eligibility

You can join if…

Open to females ages 18-40

  1. Must currently meet DSM-5 criteria for AN-R and AN Spectrum Disorders (i.e., Atypical AN) based on the Structured Clinical Interview for the DSM-5 (SCID-5-RV)
  2. Have a duration of illness ≥ 6 months
  3. Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician

You CAN'T join if...

  1. Psychotic illness/other mental illness requiring inpatient hospitalization
  2. Current dependence on drugs or alcohol
  3. Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight or liver disease which may affect pharmacokinetics of the study drug
  4. Use of other psychoactive medications
  5. Significant changes in medication in past month
  6. Expression of acute suicidality
  7. Previous hypersensitivity reaction to Epidiolex or any of its constituents

Location

  • University of California San Diego accepting new patients
    San Diego California 92121 United States

Lead Scientist at University of California Health

  • Guido K Frank, MD (ucsd)
    Professor In Residence, Psychiatry. Authored (or co-authored) 103 research publications. Research interests: Eating Disorders · Anorexia Nervosa · Bulimia Nervosa · Binge Eating Disorder · ARFID · Brain Imaging · Neuroscience · Treatment · Psychopharmacology · Psychotherapy.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04878627
Phase
Phase 1
Study Type
Interventional
Last Updated