Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT05176418
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be a double-blind, placebo-controlled study employing a mixed design: nicotine dose as the between-subject and delivery rate as the within-subject factors.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2021-11-19', 'studyFirstSubmitQcDate': '2021-12-14', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Effects Questionnaire mean score', 'timeFrame': 'up to five years', 'description': 'The DEQ measures Good Drug Effect and consists of 11 questions with total score range from 0-100. Higher scores indicate more positive effects.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nicotine Dependence']}, 'descriptionModule': {'briefSummary': "This project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. Will use pulsed IV nicotine administration which closely matches nicotine delivery by inhaled tobacco use.", 'detailedDescription': 'Seventy smokers will be randomized to nicotine doses of either 0.2 or 1 mg per 70 kg body weight. Across 5 test sessions, within each dose group, participants will be randomly assigned to a sequence of 5 treatment conditions: placebo (saline) and 4 different delivery rates of nicotine. In each session, participants will receive either nicotine- or saline-pulsed infusions that will be delivered every 30 seconds for a total of 10 pulsed infusions. While receiving the pulsed infusions, participants will inhale a tobacco-flavored EC without nicotine, which will allow for a closer matching of the sensory aspects of inhaled tobacco use. There are four pulse duration conditions for the nicotine sessions: 2-, 4-, 6- and 8-second pulses. For those assigned to 1.0 mg/70kg nicotine dose, the pulse duration conditions correspond to nicotine delivery rates of 50, 25, 16.6, and 12.5 mcg nicotine/second. For those assigned to 0.2 mg/70 kg dose, the corresponding delivery rates will be 10, 5, 3.3 and 2.5 mcg nicotine/second. Participants in both nicotine dose groups will each have one placebo test session wherein they will receive 10 pulsed-saline infusions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male, aged 21 to 55 years;\n* past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests\n* women, -using acceptable birth control methods.\n\nExclusion Criteria:\n\n* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study\n* risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD\n* regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)\n* current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine\n* for women, pregnant as determined by pregnancy screening, or breast feeding\n* seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.'}, 'identificationModule': {'nctId': 'NCT05176418', 'briefTitle': 'IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate', 'orgStudyIdInfo': {'id': 'HIC 2000032210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'delivery rate for nicotine dose 1mg/70kg', 'description': 'delivery rate 50,35, 16.6 and 12.5 ug per second', 'interventionNames': ['Drug: low dose Nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delivery rate for nicotine dose 0.2mg/70kg', 'description': 'delivery rate 10,5, 3.3 and 2.5', 'interventionNames': ['Drug: high dose Nicotine']}], 'interventions': [{'name': 'low dose Nicotine', 'type': 'DRUG', 'otherNames': ['IV nicotine 1mg/70kg'], 'description': 'IV nicotine infused over different delivery rates', 'armGroupLabels': ['delivery rate for nicotine dose 1mg/70kg']}, {'name': 'high dose Nicotine', 'type': 'DRUG', 'otherNames': ['IV Nicotine 0.2/70kg'], 'description': 'IV Nicotine infused over different delivery rates', 'armGroupLabels': ['Delivery rate for nicotine dose 0.2mg/70kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stacy Minnix, B.S.', 'role': 'CONTACT', 'email': 'stacy.minnix@va.gov', 'phone': '203-932-5711', 'phoneExt': '4823'}], 'facility': 'VA Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'centralContacts': [{'name': 'Mehmet Sofuoglu,, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'mehmet.sofuoglu@yale.edu', 'phone': '203-932-5711', 'phoneExt': '4809'}], 'overallOfficials': [{'name': 'Mehmet Sofuoglu, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Mehmet Sofuoglu', 'investigatorAffiliation': 'Yale University'}}}}