Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-24 @ 9:24 PM
Study NCT ID:
NCT02294266
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2014-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mephedrone and Alcohol Interactions in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019969', 'term': 'Amphetamine-Related Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548233', 'term': 'mephedrone'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2014-11-17', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in drunkenness and drowsiness and effects', 'timeFrame': 'From pre-dose (baseline, 0h) to 6h post-dose', 'description': 'Drunkenness and drowsiness effects will be measured using rate scales (visual analogue scales).'}], 'secondaryOutcomes': [{'measure': 'Change in other subjective effects', 'timeFrame': 'From pre-dose (baseline, 0h) to 6h post-dose', 'description': 'Subjective effects will be measured using rate scales (visual analogue scales, the Addiction Research Center Inventory and the Evaluation of the Subjective Effects of Substances with Abuse Potential Questionnaires). All these instruments include measures of euphoria-good effects and other feelings induced by psychostimulants and alcohol.'}, {'measure': 'Change in blood pressure', 'timeFrame': 'From pre-dose (baseline, 0h) to 6h post-dose', 'description': 'Systolic and diastolic blood pressure'}, {'measure': 'Change in psychomotor function', 'timeFrame': 'From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose', 'description': 'Psychomotor function will be measured using Critical tracking task (CTT) and Divided Attention Task (DAT).'}, {'measure': 'Change in memory function', 'timeFrame': 'From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose', 'description': 'Memory function will be measured using Spatial Memory Task (SMT).'}, {'measure': 'Area Under the Concentration-Time Curve (AUC 0-24h)', 'timeFrame': 'From pre-dose (baseline, 0h) to 0.15, 0.3, 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose', 'description': 'Calculation of AUC of the concentrations of mephedrone and its metabolites in blood and urine.'}, {'measure': 'Area Under the Concentration-Time Curve (AUC 0-10h)', 'timeFrame': 'From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose', 'description': 'Calculation of AUC of the concentrations of alcohol in blood.'}, {'measure': 'Number of Participants with Serious and Non-Serious Adverse Events', 'timeFrame': '7 days after each', 'description': 'Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators.'}, {'measure': 'Elimination hal-life', 'timeFrame': 'From pre-dose (baseline, 0h) to 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24h post-dose', 'description': 'Calculation of elimination hal-life from concentrations of mephedrone and its metabolites in blood and urine.'}, {'measure': 'Elimination hal-life', 'timeFrame': 'From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, an 10h post-dose', 'description': 'Calculation of elimination hal-life from concentrations of alcohol in blood.'}, {'measure': 'Change in heart rate', 'timeFrame': 'From pre-dose (baseline, 0h) to 6h post-dose', 'description': 'Measure of heart rate'}, {'measure': 'Change in pupil diameter', 'timeFrame': 'From pre-dose (baseline, 0h) to 6h post-dose', 'description': 'Measure of pupil diameter'}, {'measure': 'Change in oral temperature', 'timeFrame': 'From pre-dose (baseline, 0h) to 6h post-dose', 'description': 'Measure of oral temperature'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Amphetamine-Related Disorders', 'Alcohol-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '32063845', 'type': 'DERIVED', 'citation': 'Papaseit E, Perez-Mana C, de Sousa Fernandes Perna EB, Olesti E, Mateus J, Kuypers KP, Theunissen EL, Fonseca F, Torrens M, Ramaekers JG, de la Torre R, Farre M. Mephedrone and Alcohol Interactions in Humans. Front Pharmacol. 2020 Jan 28;10:1588. doi: 10.3389/fphar.2019.01588. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are 1) to evaluate the pharmacological effects after oral coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.', 'detailedDescription': 'Mephedrone (4-methylmetcathinone, 4-MMC) is a new psychoactive substance (NPS). Mephedrone is frequently used in combination with alcohol. At present, the effects of the interaction between mephedrone and alcohol in humans have not been previously evaluated in randomized controlled clinical trials.\n\nThe aims of this study are 1) to evaluate the pharmacological effects after oral coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Understanding and accepting the study procedures and signing the informed consent.\n* Male adults volunteers (18-45 years old).\n* Clinical history and physical examination demonstrating no organic or psychiatric disorders.\n* The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.\n* Recreational use of amphetamines, ecstasy and hallucinogen derivate, mephedrone or other cathinone on at least 6 occasions (two in the previous year) without any adverse reactions.\n* Recreational use of alcohol (ethanol). Previous experience in acute alcohol intoxication.\n* Extensive metabolizer or intermediate metabolizer phenotype for cytochrome P-450-2D6 (CYP2D6) activity determined using dextromethorphan as a selective probe drug.\n* The weight does not exceed 15% of ideal weight that applies according to size and will be between 60 and 100 Kg. Minor variations will be accepted as normal limits, if the researchers considered it clinically insignificant.\n\nExclusion Criteria:\n\n* Not meeting the inclusion criteria.\n* Daily consumption \\>20 cigarettes and \\>4 standard units of ethanol.\n* Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.\n* Presence of major psychiatric disorders.\n* Present history of abuse or drug dependence (except for nicotine dependence).\n* Past history of drug dependence (except for nicotine dependence). Past history of drug abuse could be included.\n* Having suffered any organic disease or major surgery in the three months prior to the study start.\n* Blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 4 weeks.\n* Subjects with intolerance or serious adverse reactions to drugs or amphetamines, ecstasy and hallucinogen derivate, mephedrone or other cathinone.\n* History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.\n* Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.\n* Subjects with positive serology to Hepatitis B, C or HIV."}, 'identificationModule': {'nctId': 'NCT02294266', 'briefTitle': 'Mephedrone and Alcohol Interactions in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Mephedrone and Alcohol Interactions After Single-dose Administration in Humans', 'orgStudyIdInfo': {'id': 'IMIMFTCL/MEF/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mephedrone and alcohol', 'description': 'Mephedrone 200 mg, single dose, oral administration\n\nAlcohol 0.8g/kg diluted in lemon-flavoured water (350 ml), single dose, oral administration', 'interventionNames': ['Drug: Mephedrone and alcohol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mephedrone', 'description': 'Mephedrone 200 mg, single dose, oral administration\n\nLemon-flavoured water (350 ml), single dose, oral administration', 'interventionNames': ['Drug: Mephedrone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alcohol', 'description': 'Lactose 200 mg, single dose, oral administration\n\nAlcohol 0.8g/kg diluted in lemon-flavoured water (350 ml), single dose, oral administration', 'interventionNames': ['Drug: Alcohol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Lactose 200 mg, single dose, oral administration\n\nLemon-flavoured water (350 ml), single dose, oral administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mephedrone and alcohol', 'type': 'DRUG', 'otherNames': ['4-methylmetcathinone; 4-MMC', 'Alcohol'], 'description': 'Single oral dose mephedrone\n\nSingle oral dose alcohol', 'armGroupLabels': ['Mephedrone and alcohol']}, {'name': 'Mephedrone', 'type': 'DRUG', 'otherNames': ['4-methylmetcathinone; 4-MMC'], 'description': 'Single oral dose mephedrone', 'armGroupLabels': ['Mephedrone']}, {'name': 'Alcohol', 'type': 'DRUG', 'description': 'Single oral dose alcohol', 'armGroupLabels': ['Alcohol']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Non-active treatment'], 'description': 'Single oral dose placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Magí Farré, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}