Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-03-30 @ 6:53 PM
Study NCT ID:
NCT01978457
Status:
TERMINATED
Last Update Posted:
2020-03-02
First Post:
2013-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003042', 'term': 'Cocaine'}, {'id': 'D011433', 'term': 'Propranolol'}], 'ancestors': [{'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Not funded', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-28', 'studyFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2013-10-31', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of patient controlled analgesic (PCA) pump activations (responses)', 'timeFrame': '3 days', 'description': 'Data on cocaine self-administration (total number of responses) will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. Data that is not normally distributed will be log transformed. If it remains highly skewed after transformation, it will be analyzed using non-parametric approaches (e.g., a non-parametric, ANOVA-Type Statistic). Normally distributed data will be analyzed employing a mixed model design, 3-way ANOVA with co-factors of placebo vs propranolol (between subjects), non-cocaine predicting cues vs. cocaine predicting cues (within subjects) and non-reactivated cocaine cues vs. reactivated cocaine cues (within subjects).'}]}, 'conditionsModule': {'conditions': ['Cocaine Dependent Subjects']}, 'descriptionModule': {'briefSummary': 'We will develop a procedure for conditioning cue-cocaine associations in human drug users. Next, we will reactivate that learning and intervene pharmacologically to prevent the reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and pharmacological approach will have significant potential for persistently inhibiting relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 - 50 years\n2. voluntary, written, informed consent\n3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations\n4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)\n5. recent street cocaine use in excess of that administered in the current study\n6. intravenous and/or smoked (crack/freebase) use\n7. positive urine toxicology screen for cocaine\n8. for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (-HCG) test\n9. able to read English and complete study evaluations.\n\nExclusion Criteria:\n\n1. Other drug dependence (except nicotine)\n2. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine\n3. a history of significant medical (cardiovascular) or neurological illness (e.g., prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrythmias of clinical significance, and/or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures)\n4. current use of psychotropic and/or potentially psychoactive prescription medication\n5. seeking treatment for drug abuse/dependence\n6. those having contraindications to beta-blocker administration, including diagnoses of asthma, bronchitis, emphysema, or a history of adverse reactions to beta-blockers (including propranolol), as well as those with bradycardia and/or first-degree or greater heart block by ECG'}, 'identificationModule': {'nctId': 'NCT01978457', 'briefTitle': 'Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction', 'orgStudyIdInfo': {'id': '1104008404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cocaine hydrochloride', 'description': 'cocaine hydrochloride', 'interventionNames': ['Drug: cocaine hydrochloride', 'Drug: propranolol', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'propranolol', 'description': 'propranolol', 'interventionNames': ['Drug: cocaine hydrochloride', 'Drug: propranolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: cocaine hydrochloride', 'Drug: propranolol']}], 'interventions': [{'name': 'cocaine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['cocaine hydrochloride', 'placebo', 'propranolol']}, {'name': 'propranolol', 'type': 'DRUG', 'armGroupLabels': ['cocaine hydrochloride', 'placebo', 'propranolol']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['cocaine hydrochloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Mental Health Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert Malison', 'investigatorAffiliation': 'Yale University'}}}}