Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cannabidiol (CBD) 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
patients receive cannabidiol at various doses for 3 weeks
Other Names:
|
| Placebo Comparator: Placebo 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
patients receive placebo for 3 weeks
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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Have a duration of illness ≥ 6 months
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Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician
Exclusion Criteria:
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Psychotic illness/other mental illness requiring inpatient hospitalization
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Current dependence on drugs or alcohol
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Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight or liver disease which may affect pharmacokinetics of the study drug
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Use of other psychoactive medications
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Significant changes in medication in past month
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Expression of acute suicidality
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Previous hypersensitivity reaction to Epidiolex or any of its constituents
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California San Diego | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- University of California, San Diego
Investigators
- Principal Investigator: Guido K Frank, MD, University of California, San Diego
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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. Review.
- 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. Review.
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