Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo-controlled, randomized, double-blind study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

patients receive cannabidiol at various doses for 3 weeks

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

patients receive placebo for 3 weeks

Interventions

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Cannabidiol

patients receive cannabidiol at various doses for 3 weeks

Intervention Type DRUG

Placebo

patients receive placebo for 3 weeks

Intervention Type DRUG

Other Intervention Names

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Epidiolex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No