Clinical trial NCT04878627: Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa
Official title: The Role of Cannabidiol in Regulating Meal Time Anxiety in Anorexia Nervous: Safety, Tolerability and Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Anorexia Nervosa
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled, randomized, double-blind study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Committee of Clinical Investigations UKU-Side Effect Scale Week 1
timeFrame: After completion of Week 1 of treatment
measure: Committee of Clinical Investigations UKU-Side Effect Scale Week 2
timeFrame: After completion of Week 2 of treatment
measure: Committee of Clinical Investigations UKU-Side Effect Scale Week 3
timeFrame: After completion of Week 3 of treatment
measure: Blood tests for cannabinol (CBD) metabolites Week 1
timeFrame: After Completion of Week 1 of treatment
measure: Blood tests for cannabinol (CBD) metabolites Week 2
timeFrame: After completion of Week 2 of treatment
measure: Blood tests for cannabinol (CBD) metabolites Week 3
timeFrame: After completion of Week 3 of treatment
measure: Change from baseline scores of Eating Disorder Examination Questionnaire (EDE-Q) over the course of treatment
timeFrame: Weekly for the duration of the project (three weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Guido K Frank, MD
role: PRINCIPAL_INVESTIGATOR
References:
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