Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-02 @ 2:47 AM
Study NCT ID:
NCT00760695
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2008-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-08', 'studyFirstSubmitDate': '2008-09-25', 'studyFirstSubmitQcDate': '2008-09-25', 'lastUpdatePostDateStruct': {'date': '2013-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Eating Disorder Inventory (EDI) scale', 'timeFrame': '4 weeks'}, {'measure': 'Motor and inner restlessness (estimated by accelerometry)', 'timeFrame': '4 weeks'}, {'measure': 'Endocrine parameters', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anorexia nervosa', 'chronic', 'dronabinol', 'weight gain', 'EDI'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.\n\nPrimary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo\n\nSecondary end points: Motor and inner restlessness and hormonal changes during the treatment.', 'detailedDescription': '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:\n\n* Weight\n* Eating Disorder Inventory (EDI) scale\n* Motor and inner restlessness (estimated by accelerometry)\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under treatment for AN.\n* Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.\n* Patients admitted to Department of Endocrinology M or Psychiatric Department P which are not expected to be discharged during the study period.\n* Age over 18.\n* Duration of the disease over 5 years.\n\nExclusion Criteria:\n\n* Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.\n* 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.\n* 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).\n* Patients not attending to the weekly controls.\n* If other severe adverse events (SAE) / drug reactions (SADR) are suspected.\n* Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse.\n* Patients with known allergy to dronabinol or sesame oil.\n* Fertile, menstruating women not using safe contraception.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT00760695', 'briefTitle': 'Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa', 'orgStudyIdInfo': {'id': '033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'the patients in this arm are receiving 2,5 mg dronabinol twice daily', 'interventionNames': ['Drug: dronabinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'the patients in this arm are receiving 2,5 mg placebo twice daily', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'dronabinol', 'type': 'DRUG', 'otherNames': ['Marinol'], 'description': 'tablets, twice daily, for 4 weeks', 'armGroupLabels': ['A']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'tablets, twice daily, for 4 weeks', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Andries Alin, physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinological Department, Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'for Alin Andries', 'investigatorFullName': 'Tine Hylle', 'investigatorAffiliation': 'Odense University Hospital'}}}}