The Role of Cannabidiol in Regulating Meal Time Anxiety in Anorexia Nervous: Safety, Tolerability and Pharmacokinetics
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Committee of Clinical Investigations UKU-Side Effect Scale Week 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Cannabidiol (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Committee of Clinical Investigations UKU-Side Effect Scale Week 1
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Guido Frank
Professor
University of California, San Diego