Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa

NCT04878627 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 191570
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (7)

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

  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.

  After completion of Week 1 of treatment

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

  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.

  After completion of Week 2 of treatment

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

  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.

  After completion of Week 3 of treatment

• Blood tests for cannabinol (CBD) metabolites Week 1

  Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.

  After Completion of Week 1 of treatment

• Blood tests for cannabinol (CBD) metabolites Week 2

  Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.

  After completion of Week 2 of treatment

• Blood tests for cannabinol (CBD) metabolites Week 3

  Blood levels for CBD, 6-OH-CBD, 7COOH-CBD, THC. The results will be compared to standard laboratory values.

  After completion of Week 3 of treatment

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

  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.

  Weekly for the duration of the project (three weeks)

Study Arms (2)

Cannabidiol (CBD)

EXPERIMENTAL

Days 1 to 7: Patients will receive CBD 2.5 mg/kg in divided doses BID for 7 days. Days 8 to 14: Patients will receive an increase dose of 7.5 mg/kg of CBD in divided doses. Days 15 to 21: Patients will receive an increased dose of 12.5 mg/kg CBD, in divided doses. If patients experience dose limiting side-effects, they ill be maintained on the lowest tolerated dose.

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Days 1 to 7: Patients will receive placebo in divided doses BID for 7 days. Days 8 to 14: Patients will continue to receive placebo in divided doses. Days 15 to 21: Patients will receive continue to receive placebo in divided doses.

Drug: Placebo

Interventions

Cannabidiol DRUG

patients receive cannabidiol at various doses for 3 weeks

Also known as: Epidiolex

Cannabidiol (CBD)

Placebo DRUG

patients receive placebo for 3 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female individuals will be enrolled. Gender eligibility is based on biological sex of participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92121, United States

Location

Related Publications (5)

• Kaye WH, Bulik CM, Thornton L, Barbarich N, Masters K. Comorbidity of anxiety disorders with anorexia and bulimia nervosa. Am J Psychiatry. 2004 Dec;161(12):2215-21. doi: 10.1176/appi.ajp.161.12.2215.

  PMID: 15569892 BACKGROUND

• Ando T, Tamura N, Mera T, Morita C, Takei M, Nakamoto C, Koide M, Hotta M, Naruo T, Kawai K, Nakahara T, Yamaguchi C, Nagata T, Ookuma K, Okamoto Y, Yamanaka T, Kiriike N, Ichimaru Y, Ishikawa T, Komaki G; Japanese Genetic Research Group For Eating Disorders. Association of the c.385C>A (p.Pro129Thr) polymorphism of the fatty acid amide hydrolase gene with anorexia nervosa in the Japanese population. Mol Genet Genomic Med. 2014 Jul;2(4):313-8. doi: 10.1002/mgg3.69. Epub 2014 Feb 24.

  PMID: 25077173 BACKGROUND

• Tambaro S, Bortolato M. Cannabinoid-related agents in the treatment of anxiety disorders: current knowledge and future perspectives. Recent Pat CNS Drug Discov. 2012 Apr 1;7(1):25-40. doi: 10.2174/157488912798842269.

  PMID: 22280339 BACKGROUND

• Rong C, Lee Y, Carmona NE, Cha DS, Ragguett RM, Rosenblat JD, Mansur RB, Ho RC, McIntyre RS. Cannabidiol in medical marijuana: Research vistas and potential opportunities. Pharmacol Res. 2017 Jul;121:213-218. doi: 10.1016/j.phrs.2017.05.005. Epub 2017 May 10.

  PMID: 28501518 BACKGROUND

• Bisogno T, Hanus L, De Petrocellis L, Tchilibon S, Ponde DE, Brandi I, Moriello AS, Davis JB, Mechoulam R, Di Marzo V. Molecular targets for cannabidiol and its synthetic analogues: effect on vanilloid VR1 receptors and on the cellular uptake and enzymatic hydrolysis of anandamide. Br J Pharmacol. 2001 Oct;134(4):845-52. doi: 10.1038/sj.bjp.0704327.

  PMID: 11606325 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Guido K Frank, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Placebo-controlled, randomized, double-blind study

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 7, 2021
• Study Start: January 20, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)