Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa

Study Overview
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Brief Summary
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A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist. Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.

Detailed Description
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The goals of this study are to reveal through a pilot trial if treatment of patients with severe chronic AN with Marinol® (dronabinol, a CB1 agonist) has significant effect on: Weight Eating Disorder Inventory (EDI) scale Motor and inner restlessness (estimated by accelerometry) Endocrine parameters (see below, paragraph 4.4) This study is a randomized, double blinded, placebo controlled cross over study. 24 patients with chronic AN meeting the inclusion criteria will be randomized either to receive Marinol® or placebo. After four weeks the two groups will undergo a wash-out period and after that will receive the opposite therapeutic regime for another four weeks.

Official Title
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Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Drug: dronabinol
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients under treatment for AN. Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period. Patients admitted to Department of Endocrinology M or Psychiatric Department P which are not expected to be discharged during the study period. Age over 18. Duration of the disease over 5 years. Exclusion Criteria: Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression. Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study. Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest). Patients not attending to the weekly controls. If other severe adverse events (SAE) / drug reactions (SADR) are suspected. Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse. Patients with known allergy to dronabinol or sesame oil. Fertile, menstruating women not using safe contraception. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>the patients in this arm are receiving 2,5 mg dronabinol twice daily | Drug: dronabinol<br>* tablets, twice daily, for 4 weeks<br>* Other names: Marinol;|
| Placebo Comparator: B<br>the patients in this arm are receiving 2,5 mg placebo twice daily | Drug: placebo<br>* tablets, twice daily, for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorder Inventory (EDI) scale |  | 4 weeks | 
| Motor and inner restlessness (estimated by accelerometry) |  | 4 weeks | 
| Endocrine parameters |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorexia nervosa, chronic, dronabinol, weight gain, EDI