INVESTIGATORS: Guido Frank, MD

STUDY LOCATION: University of California, San Diego

PROJECT TITLE: The Role of Cannabidiol (CBD) in Regulating Meal Time Anxiety in Anorexia Nervosa: Safety, Tolerability and Pharmacokinetics

FUNDING SOURCE: Center for Medicinal Cannabis Research

PROJECT TYPE: Clinical Study

STATUS: Active (Enrolling)

ABSTRACT:

Because there are no proven treatments that normalize core symptoms in adult anorexia nervosa (AN), a disorder with high chronicity and mortality, many individuals seek out alternative approaches to care.  Recent evidence has suggested that exaggerated anxiety and diminished reward or motivation to eat play a key role in causing AN symptoms and poor outcome.   The endocannabinoid system is involved in the regulation of many central and peripheral functions, including appetite, food intake, and energy balance and 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 like tetrahydrocannabinol (THC) that can increase anxiety.  As states have legalized cannabis, THC and cannabidiol (CBD) products are being used by patients with AN.  CBD is of interest given the possibility that this drug might reduce anxiety.  However, there is inconsistent evidence on CBD's impact on appetite, which is highly relevant in treatment of AN.  This project would be the first study to utilize pure, synthesized CBD to investigate the safety, tolerability, and pharmacokinetics in adult patients with AN.  We propose a placebo-controlled, randomized, double-blind, pilot study, to evaluate and compare the acute and maintenance pharmacological effects of CBD at various doses compared to placebo in adult patients with AN.  Our primary aim is to characterize CBD's pharmacokinetic and safety profile in patients with AN as well as the clinical effect of CBD on 1) anxiety; 2) on AN symptoms, and 3) on restrictive eating behavior using a test meal.  Knowing the safety concerns of CBD has immediate implications on clinical treatment, including effects on weight restoration, and if well tolerated and shown to have the potential to alleviate anxiety, CBD would be an important treatment to further investigate in a clinical trial.