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Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT04878627
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Guido Frank, University of California, San Diego

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
Anorexia Nervosa Drug: Cannabidiol Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo-controlled, randomized, double-blind study
Masking: Double (Participant, 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.
Primary Purpose: Treatment
Official Title: The Role of Cannabidiol in Regulating Meal Time Anxiety in Anorexia Nervous: Safety, Tolerability and Pharmacokinetics
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Cannabidiol

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 Name: Epidiolex

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female individuals will be enrolled. Gender eligibility is based on biological sex of participants.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878627


Contacts
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Contact: Megan E Shott, BS 858-246-5272 mshott@health.ucsd.edu

Locations
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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92121
Contact: Megan E Shott, BS    858-246-5272    mshott@health.ucsd.edu   
Contact: Guido Frank, MD       gfrank@health.ucsd.edu   
Principal Investigator: Guido Frank, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Guido K Frank, MD University of California, San Diego
Publications:
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Responsible Party: Guido Frank, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04878627    
Other Study ID Numbers: 191570
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Cannabidiol
Anticonvulsants