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

Condition(s) targeted: Anorexia Nervosa

Intervention: dronabinol (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Odense University Hospital

Official(s) and/or principal investigator(s):
Andries Alin, physician, Principal Investigator, Affiliation: Endocrinological Department, Odense University Hospital

Overall contact:
Alin Andries, Phone: +4524420221, Email: alin@dadlnet.dl

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.

Official title: Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome: Weight gain

Secondary outcome:

Eating Disorder Inventory (EDI) scale

Motor and inner restlessness (estimated by accelerometry)

Endocrine parameters

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Alin Andries, Phone: +4524420221, Email: alin@dadlnet.dl

Odense University Hospital, Odense 5000, Denmark; Recruiting
René K. Stovring, MD, PhD, Phone: +45 6541 3378, Email: rene.k.stoving@dadlnet.dk
Andries Alin, physician, Principal Investigator

Starting date: October 2008
Ending date: December 2011
Last updated: January 8, 2009