Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-28 @ 7:12 PM
Study NCT ID:
NCT03840694
Status:
TERMINATED
Last Update Posted:
2021-05-20
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'PI leaving for another institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Oxygen Level Dependent (BOLD) Activation', 'timeFrame': 'Approximately 1-3 weeks', 'description': 'BOLD activation in brain reward network regions'}, {'measure': 'Ecological Momentary Assessment (EMA) Pleasure Ratings', 'timeFrame': '2-6 weeks', 'description': 'Anticipated and actual pleasure ratings acquired each day during EMA portion of study. Individual items are based on the 12-item Tripartite Pleasure Inventory (TPI). Participants rate their anticipated pleasure for activities they expect to engage in each day using a 0 (No pleasure) to 4 (Extreme pleasure) scale in the morning. They will then rate their actual experienced pleasure for activities they actually did engage in the evening using the same scale. Scores are summed across items for a theoretical range of 0-48.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cigarette Smoking', 'Nicotine Withdrawal']}, 'descriptionModule': {'briefSummary': "This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Eligible participants will work with a researcher to develop brief scripts about times when they smoke and do other activities. Next, participants will attend two magnetic resonance imaging (MRI) scans - one after abstaining from smoking for 24 hours and the other after smoking as usual. After the second MRI, participants will answer questions on their phone every day for two weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy\n* Right-handed\n* Smoke \\>= 10 cigarettes per day\n* Smoking regularly for \\>= 1 year\n* Carbon Monoxide (CO) \\> 8 at screening (or urinary cotinine \\> 100)\n* Own a compatible smartphone\n* Able to read and understand English\n* Able to identify at least 4 pleasurable activities they do not do concurrently with smoking or associate with smoking\n\nExclusion Criteria:\n\n* Regular use of "roll your own" cigarettes\n* Planning to quit smoking within the next 60 days\n* Current or planned smoking cessation treatment\n* Regular use of smokeless tobacco or other nicotine products\n* Expired CO \\> 80 parts per million\n* Breath alcohol \\> .000 at screening (re-attempts are allowed)\n* Positive toxicology screen for exclusionary drugs\n* Use of exclusionary medications\n* Significant medical problems\n* Currently breastfeeding, pregnant, or planning to become pregnant\n* Enrollment in another study utilizing Spectrum cigarettes within the last 3 months\n* Irregular slee-wake cycles (e.g. swing-shift work, unusual sleep patterns)'}, 'identificationModule': {'nctId': 'NCT03840694', 'acronym': 'NicWith', 'briefTitle': 'Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior', 'orgStudyIdInfo': {'id': 'Pro00101055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Smoking Abstinence', 'description': 'Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing', 'interventionNames': ['Other: Smoking Abstinence']}, {'type': 'OTHER', 'label': 'Ad Lib Smoking', 'description': 'Participants will continue smoking as usual (i.e. "ad lib") before one MRI scan and smoke one additional cigarette immediately prior to scanning. Continued smoking will be confirmed using exhaled carbon monoxide breath testing.', 'interventionNames': ['Other: Ad Lib Smoking']}], 'interventions': [{'name': 'Smoking Abstinence', 'type': 'OTHER', 'description': 'Participants will abstain from smoking for 24 hours.', 'armGroupLabels': ['Smoking Abstinence']}, {'name': 'Ad Lib Smoking', 'type': 'OTHER', 'description': 'Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.', 'armGroupLabels': ['Ad Lib Smoking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Jason A Oliver, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'We anticipate making data available within 6 months of study completion. It will be available for an indefinite period of time.', 'ipdSharing': 'YES', 'description': 'Detailed protocols, datasets and additional information will be available from the Principal Investigator and research team upon request. In order to maintain compliance with the Health Insurance Portability and Accountability Act (HIPAA) requirements, as well as university data security policies, all data will be anonymized according to HIPAA guidelines prior to being shared. Individual participant scripts will not be made publicly available due to privacy concerns and because this could impact the nature of information participants were willing to provide for scripts. Data will be provided in widely accessible formats for both self-report and imaging data. We will work with the Office of Research Contracts to obtain guidance regarding any required Data Use Agreements as needed.', 'accessCriteria': 'Contact PI for details.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Food and Drug Administration (FDA)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}