Anorexia Nervosa
Conditions
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.
Interventions
DRUGCannabidiol
patients receive cannabidiol at various doses for 3 weeks
DRUGPlacebo
patients receive placebo for 3 weeks
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The PI and research coordinator administering the medication will be blinded to the randomization schedule. The research subject will be blinded to what medication she receives.
Intervention model description
Placebo-controlled, randomized, double-blind study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Committee of Clinical Investigations UKU-Side Effect Scale Week 1 | After completion of Week 1 of treatment | The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects. |
| Committee of Clinical Investigations UKU-Side Effect Scale Week 2 | After completion of Week 2 of treatment | The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects. |
| Committee of Clinical Investigations UKU-Side Effect Scale Week 3 | After completion of Week 3 of treatment | The Committee of Clinical Investigations (UKU) scale is used to rate psychiatric (e.g., depression, failing memory, concentration difficulty), neurological (e.g., rigidity, tremor, epileptic seizure), and autonomic (e.g., nausea, diarrhea, tachycardia) side effects, plus others. Higher scores indicate more side effects. |
| Blood tests for cannabinol (CBD) metabolites Week 1 | After Completion of Week 1 of treatment | Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values. |
| Blood tests for cannabinol (CBD) metabolites Week 2 | After completion of Week 2 of treatment | Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values. |
| Blood tests for cannabinol (CBD) metabolites Week 3 | After completion of Week 3 of treatment | Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values. |
| Change from baseline scores of Eating Disorder Examination Questionnaire (EDE-Q) over the course of treatment | Weekly for the duration of the project (three weeks) | Assesses the change from baseline in BMI, Eating Restraint, Eating Concern, Shape Concern, Weight Concern over the course of treatment. Each of those subscales is rated between 0 and 5. Subscales are calculated based on the average scores for the respective subscale. Higher scores indicate poorer outcome. |
Countries
United States
Outcome results
None listed