Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 7:19 AM
Study NCT ID:
NCT07086794
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cocaine and Pentoxifylline (BED IN 47)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003042', 'term': 'Cocaine'}, {'id': 'D010431', 'term': 'Pentoxifylline'}], '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': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reinforcing Effects of Cocaine', 'timeFrame': '9 times over approximately 1 month inpatient admission', 'description': 'Number of Times Subjects Choose Cocaine (Maximum of 5 Choices) Over Money'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cocaine Use Disorder']}, 'descriptionModule': {'briefSummary': 'This will be a human laboratory study evaluating the influence of pentoxifylline treatment on the effects of cocaine. Supported by and included in the Helping to End Addiction Long-term® (HEAL) Initiative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. able to speak/read English,\n2. not seeking treatment for drug use at the time of the study,\n3. female or male between the ages of 18 and 55 years,\n4. recent smoked or intravenous cocaine use verified by benzoylecgonine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for CUD,\n5. judged to be medically and psychiatrically healthy by study physicians other than the diagnosis for CUD at the time of screening,\n6. ECG, read by a cardiologist, within normal limits,\n7. females using an effective form of birth control and not pregnant or breastfeeding and 8) no known contraindications or allergies to pentoxifylline.\n\nExclusion Criteria:\n\n1. unable to speak/read English,\n2. seeking treatment for drug use,\n3. under 18 years or over 55 years,\n4. no recent smoked or intravenous cocaine use as indicated by benzoylecgonine negative urine and no DSM-5 diagnosis of CUD,\n5. judged to be medically or psychiatrically unhealthy by study physicians at the time of screening,\n6. ECG, read by a cardiologist, outside normal limits,\n7. females not using an effective form of birth control or pregnant or breastfeeding,\n8. contraindications or allergies to pentoxifylline, and\n9. Self-reported history of head trauma, seizure, CNS tumors, or use of concomitant medications that lower seizure threshold, or first-degree family history of seizures.'}, 'identificationModule': {'nctId': 'NCT07086794', 'briefTitle': 'Cocaine and Pentoxifylline (BED IN 47)', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Targeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline', 'orgStudyIdInfo': {'id': '104811'}, 'secondaryIdInfos': [{'id': 'R01DA063069', 'link': 'https://reporter.nih.gov/quickSearch/R01DA063069', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will be treated daily with an oral placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Pentoxifylline Dose 1', 'description': 'Subjects will be treated daily with oral pentoxifylline (1200 mg).', 'interventionNames': ['Drug: Placebo', 'Drug: Cocaine (IV)', 'Drug: Pentoxifylline']}, {'type': 'EXPERIMENTAL', 'label': 'Pentoxifylline Dose 2', 'description': 'Subjects will be treated daily with oral pentoxifylline (1600 mg).', 'interventionNames': ['Drug: Placebo', 'Drug: Cocaine (IV)', 'Drug: Pentoxifylline']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'The effects of placebo will be determined.', 'armGroupLabels': ['Pentoxifylline Dose 1', 'Pentoxifylline Dose 2', 'Placebo']}, {'name': 'Cocaine (IV)', 'type': 'DRUG', 'description': 'The effects of IV Cocaine will be determined.', 'armGroupLabels': ['Pentoxifylline Dose 1', 'Pentoxifylline Dose 2']}, {'name': 'Pentoxifylline', 'type': 'DRUG', 'description': 'The effects of pentoxifylline will be determined.', 'armGroupLabels': ['Pentoxifylline Dose 1', 'Pentoxifylline Dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40507', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William W Stoops, PhD', 'role': 'CONTACT', 'email': 'william.stoops@uky.edu', 'phone': '859-257-5388'}, {'name': 'William W Stoops, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Psychopharmacology of Addiction Laboratory', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'William W Stoops, PhD', 'role': 'CONTACT', 'email': 'william.stoops@uky.edu', 'phone': '859-257-5388'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William Stoops', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'William Stoops', 'investigatorAffiliation': 'University of Kentucky'}}}}