Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-04-16 @ 7:19 PM
Study NCT ID:
NCT03190161
Status:
COMPLETED
Last Update Posted:
2019-08-15
First Post:
2017-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music to Reduce Use of Smoking in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Snaith-Hamilton Pleasure Scale (SHAPS)', 'timeFrame': '1 Day', 'description': 'Measures Pleasure Pre Music Session'}, {'measure': 'Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session', 'timeFrame': '1 Day', 'description': 'Measures Pleasure Post Music Session'}, {'measure': 'Pleasure Rating Scale (PRS)', 'timeFrame': '1 Day', 'description': 'Measures Pleasure Pre Music Session'}, {'measure': 'Pleasure Rating Scale (PRS) Post Music Session', 'timeFrame': '1 Day', 'description': 'Measures Pleasure Post Music Session'}, {'measure': 'Questionnaire of Smoking Urges-Brief (QSU-B)', 'timeFrame': '1 Day', 'description': 'Measures Cravings Pre Music Session'}, {'measure': 'Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session', 'timeFrame': '1 Day', 'description': 'Measures Cravings Post Music Session'}, {'measure': 'Minnesota Nicotine Withdrawal Scale (MNWS)', 'timeFrame': '1 Day', 'description': 'Measures Withdrawal Pre Music Session and Post Music Session'}, {'measure': 'Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session', 'timeFrame': '1 Day', 'description': 'Measures Withdrawal Post Music Session'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia'], 'conditions': ['Schizophrenia', 'Nicotine Dependence', 'Smoking, Tobacco']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the impact of self-selected music listening which targets disrupting the reward process maintaining smoking and additionally attenuating the reward processing deficits associated with schizophrenia. Five participants with schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual session of self-selected music listening for a half an hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder\n* smoked at least 10 cigarettes per day for the past month\n* score of 4 or more on the Fagerstrom Test for Nicotine Dependence73\n* psychiatric stability (e.g., no psychiatric hospitalizations within the last year, no expectation for medication change during study participation, no active suicidal ideation, no symptoms that interfere with ability to participate in study activities)\n* the capacity to participate in the informed consent process\n\nExclusion Criteria:\n\n* being medically unstable (e.g., medical condition that requires frequent medical appointments or hospitalizations and interferes with ability to participate in study activities)\n* report active substance abuse or testing positive drug or alcohol use\n* taking bupropion, varenicline, nicotine replacement products and/or involved in any other smoking cessation treatment\n* participating in any treatment or activity that includes music as a focus\n* having a seizure disorder, other neurological illnesses, or a family history of seizures'}, 'identificationModule': {'nctId': 'NCT03190161', 'briefTitle': 'Music to Reduce Use of Smoking in Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Music to Reduce Use of Smoking in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': '17-00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Schizophrenia Patients', 'description': 'Clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder', 'interventionNames': ['Behavioral: Music session']}], 'interventions': [{'name': 'Music session', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to refrain from smoking from 24 hours before the music listening session as confirmed by breath carbon monoxide level \\<6 ppm on the day of the session. They will be contacted by phone or in person at the clinic as a reminder prior.', 'armGroupLabels': ['Schizophrenia Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Kathleen Tracy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}