Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-04-27 @ 4:43 AM
Study NCT ID:
NCT02825459
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2016-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013375', 'term': 'Substance Withdrawal Syndrome'}, {'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D040261', 'term': 'Harm Reduction'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)', 'timeFrame': '6 days', 'description': 'The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions.'}], 'secondaryOutcomes': [{'measure': 'Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)', 'timeFrame': '6 days', 'description': 'The investigators will use the mean score for each of the 16 symptoms across participants during abstinence and use conditions.'}, {'measure': 'Questionnaire of E-cigarette Urges (brief)', 'timeFrame': '6 days', 'description': 'This is a revision of the brief version Questionnaire of Smoking Urges that asks about urges for e-cigarettes rather than tobacco cigarettes.'}, {'measure': 'Questionnaire of Smoking Urges- brief version', 'timeFrame': '6 days', 'description': 'This 2-item scale asks about intensity and frequency of urges.'}, {'measure': 'Heart rate', 'timeFrame': '6 days', 'description': 'Measured for 30 sec after sitting for 15 minutes'}, {'measure': 'E-cigarette Purchase Task', 'timeFrame': '6 days', 'description': 'This is a modification of the Cigarette Purchase Task that asks how much users would expend to obtain their usual amount of e-liquids to use.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['abstinence', 'abuse liability', 'electronic cigarette', 'e-cigarette', 'electronic nicotine delivery device', 'harm reduction', 'nicotine', 'nicotine dependence', 'smoking', 'smoking cessation', 'tobacco', 'vape', 'vaping', 'withdrawal'], 'conditions': ['Substance Withdrawal Syndrome']}, 'referencesModule': {'references': [{'pmid': '31504882', 'type': 'DERIVED', 'citation': 'Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Adult Never-Smokers: A Pilot Experimental Study. Nicotine Tob Res. 2020 Apr 21;22(5):740-746. doi: 10.1093/ntr/ntz169.'}, {'pmid': '31352486', 'type': 'DERIVED', 'citation': 'Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Former Smokers: A Pre-Post Clinical Trial. Nicotine Tob Res. 2020 Apr 21;22(5):734-739. doi: 10.1093/ntr/ntz129.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.', 'detailedDescription': 'Study Design: The investigators will recruit 120 individuals who are long-term daily and exclusive users of nicotine-containing e-cigarettes. Participants will be asked to use their own e-cigarette as usual during the first week of the study and to then stop their use of e-cigarettes for 6 days. The total study duration will be 14 days. Participants will be instructed to continue abstinence from other tobacco and nicotine products during the entire study. The investigators will use an escalating payment system with bonuses based on breath and urine samples to encourage compliance.\n\nEvery day during the study, participants will report e-cigarette and tobacco cigarette use and monitor symptoms of nicotine withdrawal via a phone call to an Interactive Voice Response system. Participants will attend 3 study visits each week to provide urine and breath samples to verify compliance, and to complete brief surveys.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Able to read and understand verbal English fluently\n* US citizen or resident alien\n* Primarily uses e-cigarette product types of refillable tanks or modified devices\n* Uses nicotine-containing e-liquid\n* Has baseline urinary cotinine concentration of \\> 100 ng/ml\n* Has used e-cigarettes daily for the last 2 months\n* Has a home or cell phone\n* Agrees to abstain from tobacco, marijuana and other illegal drugs during study\n\nExclusion Criteria:\n\n* Smoked \\> 5 tobacco cigarettes in the last month\n* Used non-cigarette nicotine, tobacco or quit smoking products on \\>5 days in the past month\n* Use of cannabis (either marijuana or synthetic cannabis) \\> 5 times in the past month or positive test for cannabis use at screening\n* Current (last 6 months) Generalized Anxiety Disorder, Major Depressive Disorder, Attention Deficit Hyperactivity Disorder or moderate/severe Substance Abuse Disorder\n* Multiple legal, social health, work or school problems in the past month due to alcohol or drug use\n* Pregnant or breastfeeding\n* Previously a participant in the current study\n* Use of prescribed or non-prescribed psychoactive medication \\> 5 times in the past month\n* Expired carbon monoxide level \\> 8ppm'}, 'identificationModule': {'nctId': 'NCT02825459', 'briefTitle': 'Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?', 'orgStudyIdInfo': {'id': '1R01CA192940-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA192940-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01CA192940-01', 'link': 'https://reporter.nih.gov/quickSearch/R01CA192940-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abstinence from e-cigarettes', 'description': 'Participants abstain from e-cigarettes and other nicotine/tobacco products for 6 days', 'interventionNames': ['Behavioral: Abstinence from e-cigarettes']}, {'type': 'NO_INTERVENTION', 'label': 'E-cigarette use', 'description': 'Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would.'}], 'interventions': [{'name': 'Abstinence from e-cigarettes', 'type': 'BEHAVIORAL', 'description': 'Abrupt cessation for 6 days', 'armGroupLabels': ['Abstinence from e-cigarettes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Battelle Memorial Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'John R Hughes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Faculty, Department of Psychiatry', 'investigatorFullName': 'John Hughes', 'investigatorAffiliation': 'University of Vermont'}}}}