Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:48 AM
Study NCT ID:
NCT00726960
Status:
UNKNOWN
Last Update Posted:
2008-08-01
First Post:
2008-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D006556', 'term': 'Heroin Dependence'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-30', 'studyFirstSubmitDate': '2008-07-30', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2008-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be self-reported pleasurable opiate effect.', 'timeFrame': 'One week'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome will be physiological opiate responses.', 'timeFrame': 'One week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heroin abuse', 'Opioids', 'Opiates', 'Substance abuse', 'Addiction'], 'conditions': ['Opioid-Related Disorders', 'Heroin Dependence', 'Substance-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.', 'detailedDescription': 'This initial proof-of-concept study focuses on evaluating whether an NK1 antagonist, aprepitant, can block opiate reward in non-dependent opiate experienced volunteers in response to a standard opiate challenge. Sixty subjects will be included in a randomized controlled study. Following a training challenge session, they will receive 1 week treatment with aprepitant or matching placebo, followed by a challenge session during which subjective and physiological responses to the opiate partial agonist buprenorphine will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 50\n* Current opiate use, without dependence\n\nExclusion Criteria:\n\n* Clinical diagnosis of opiate dependence\n* Positive urine screen for opiates on day of challenge sessions\n* Meet diagnostic criteria for any other substance abuse disorder except nicotine within the last 12 months.\n* Any ongoing prescription medication other than oral contraceptives or hormone replacement\n* Any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.'}, 'identificationModule': {'nctId': 'NCT00726960', 'briefTitle': 'Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study', 'orgStudyIdInfo': {'id': 'Aprepitant 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Aprepitant', 'interventionNames': ['Drug: aprepitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Pseudo-placebo - buprenorphine']}], 'interventions': [{'name': 'aprepitant', 'type': 'DRUG', 'otherNames': ['Emend'], 'description': 'Oral, 125 mg once daily for one week', 'armGroupLabels': ['1']}, {'name': 'Pseudo-placebo - buprenorphine', 'type': 'DRUG', 'otherNames': ['Subutex'], 'description': 'Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital, Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Markus Heilig, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}, {'name': 'Johan Kakko, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health and Social Affairs, Sweden', 'class': 'OTHER_GOV'}, {'name': 'County of Stockholm', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Markus Heilig, MD, PhD', 'oldOrganization': 'Karolinska Universitetssjukhuset'}}}}