Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa - Full Text View

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00760695

Purpose

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.

Condition	Intervention	Phase
Anorexia Nervosa	Drug: dronabinol Drug: placebo	Phase III

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Weight gain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Eating Disorder Inventory (EDI) scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Motor and inner restlessness (estimated by accelerometry) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Endocrine parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator the patients in this arm are receiving 2,5 mg dronabinol twice daily	Drug: dronabinol tablets, twice daily, for 4 weeks
B: Placebo Comparator the patients in this arm are receiving 2,5 mg placebo twice daily	Drug: placebo tablets, twice daily, for 4 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760695

Contacts

Contact: Alin Andries	+4524420221	alin@dadlnet.dl
Contact: René Støving, phd		rene.k.stoving@dadlnet.dk

Locations

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

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Andries Alin, physician

Endocrinological Department, Odense University Hospital

More Information

Responsible Party:	Department of Endocrinology, Odense University Hospital ( Alin Andries )
Study ID Numbers:	033
Study First Received:	September 25, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00760695
Health Authority:	Denmark: National Board of Health

Keywords provided by Odense University Hospital:

anorexia nervosa
chronic
dronabinol
weight gain
EDI

Study placed in the following topic categories:

Tetrahydrocannabinol
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Mental Disorders

Anorexia
Anorexia Nervosa
Weight Gain
Eating Disorders

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Hallucinogens
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009