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NCT Number: NCT04878627

Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of California San Diego

San Diego, California, 92121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Have a duration of illness ≥ 6 months
  • Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician

Exclusion criteria

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

Treatment and study plan

Cannabidiol

Drug

patients receive cannabidiol at various doses for 3 weeks

Other names: Epidiolex

Placebo

Drug

patients receive placebo for 3 weeks

Primary outcomes

  1. Committee of Clinical Investigations UKU-Side Effect Scale Week 1

    Time frame: 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.

  2. Committee of Clinical Investigations UKU-Side Effect Scale Week 2

    Time frame: 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.

  3. Committee of Clinical Investigations UKU-Side Effect Scale Week 3

    Time frame: 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.

  4. Blood tests for cannabinol (CBD) metabolites Week 1

    Time frame: 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.

  5. Blood tests for cannabinol (CBD) metabolites Week 2

    Time frame: 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.

  6. Blood tests for cannabinol (CBD) metabolites Week 3

    Time frame: 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.

  7. Change from baseline scores of Eating Disorder Examination Questionnaire (EDE-Q) over the course of treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 7, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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