Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-27 @ 3:01 PM
Study NCT ID:
NCT00895804
Status:
COMPLETED
Last Update Posted:
2009-06-15
First Post:
2009-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D019969', 'term': 'Amphetamine-Related Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018817', 'term': 'N-Methyl-3,4-methylenedioxyamphetamine'}, {'id': 'D010869', 'term': 'Pindolol'}], 'ancestors': [{'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-12', 'studyFirstSubmitDate': '2009-05-07', 'studyFirstSubmitQcDate': '2009-05-07', 'lastUpdatePostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of pindolol on subjective response to MDMA', 'timeFrame': '24h'}], 'secondaryOutcomes': [{'measure': 'Effect of pindolol on physiological response to MDMA', 'timeFrame': '24h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MDMA', 'beta adrenergic', 'Ecstasy'], 'conditions': ['Mood Disorder', 'Substance-Related Disorders', 'Amphetamine-Related Disorders']}, 'descriptionModule': {'briefSummary': 'MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of cardiovascular and adverse effects of MDMA is unknown.', 'detailedDescription': 'We investigated the interactive effects of the beta-blocker pindolol (20 mg) with MDMA (1.6 mg/kg) on heart rate, blood pressure, body temperature, and adverse effects in a double-blind placebo-controlled study in 16 healthy subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sufficient understanding of the German language\n* Subjects understand the procedures and the risks associated with the study\n* Participants must be willing to adhere to the protocol and sign the consent form\n* Participants must be willing to refrain from taking illicit psychoactive substances during the study.\n* Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids after midnight of the evening before the study session.\n* Participants must be willing not to drive a traffic vehicle in the evening of the study day.\n* Body mass index: 18-25 kg/m2\n\nExclusion Criteria:\n\n* Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (\\>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.\n* Current or previous psychotic or affective disorder\n* Psychotic or affective disorder in first-degree relatives\n* Prior illicit drug use (except THC-containing products) more than 5 times or any time within the previous 2 months.\n* Participation in another clinical trial (currently or within the last 30 days)\n* Use of medications that are contraindicated or otherwise interfere with the effects of the study medications.'}, 'identificationModule': {'nctId': 'NCT00895804', 'briefTitle': 'Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)', 'orgStudyIdInfo': {'id': 'E-003/2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pindolol, Placebo', 'description': 'Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.', 'interventionNames': ['Drug: MDMA', 'Drug: Pindolol']}, {'type': 'OTHER', 'label': 'MDMA, Placebo', 'description': 'Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.', 'interventionNames': ['Drug: MDMA', 'Drug: Pindolol']}], 'interventions': [{'name': 'MDMA', 'type': 'DRUG', 'description': 'capsule, 1.6 mg/kg body weight, single dose', 'armGroupLabels': ['MDMA, Placebo', 'Pindolol, Placebo']}, {'name': 'Pindolol', 'type': 'DRUG', 'description': 'capsule of 20mg pindolol, single dose 1h before MDMA', 'armGroupLabels': ['MDMA, Placebo', 'Pindolol, Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Heffter Research Center, University Hospital of Psychiatry', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Matthias E Liechti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heffter Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Matthias E. Liechti', 'oldOrganization': 'Universtity Hospital Basel'}}}}