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

Odense University Hospital

Status and phase

Completed

Phase 3

Conditions

Anorexia Nervosa

Treatments

Drug: placebo

Drug: dronabinol

Study type

Interventional

Funder types

Other

Identifiers

NCT00760695

033

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.