Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT00508560
Status:
TERMINATED
Last Update Posted:
2015-06-26
First Post:
2007-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Stopped due to low recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-25', 'studyFirstSubmitDate': '2007-07-27', 'studyFirstSubmitQcDate': '2007-07-27', 'lastUpdatePostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment sessions attended', 'timeFrame': '11 weeks'}], 'secondaryOutcomes': [{'measure': 'Reduction in cigarettes per day', 'timeFrame': '3 and 6 months'}, {'measure': '7- and 30-day point prevalence abstinence', 'timeFrame': '3 and 6 months'}, {'measure': 'Continuous abstinence from quit date', 'timeFrame': '3 and 6 months'}, {'measure': 'Days to relapse from quit date', 'timeFrame': 'Up to 6 months'}, {'measure': 'Change in BPRS scores', 'timeFrame': '3 and 6 months'}, {'measure': 'Change in PHQ-9 scores', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contingency management', 'Smoking cessation', 'Psychotic disorders', 'Veterans'], 'conditions': ['Nicotine Dependence', 'Psychotic Disorders']}, 'descriptionModule': {'briefSummary': 'This study examines the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses who want to quit smoking. We hypothesize that participants randomized to receive contingent rewards for group attendance will attend more treatment sessions than those in the control group.', 'detailedDescription': 'Schizophrenia and other psychotic disorders are highly prevalent in the VA population and are associated with high rates of smoking. Although smoking cessations approaches that work for non-schizophrenic patients such as behavioral counseling and medications appear to be efficacious for schizophrenic smokers, a major obstacle in providing adequate treatment is poor attendance at treatment sessions. Contingency management has been shown to shape treatment behavior in non-schizophrenic smokers and to shape other behaviors such as cocaine use and exercise in schizophrenics.\n\nThe intention of this project is to examine the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses and to compare two different approaches to providing contingent incentives in this context. Subjects in the experimental condition draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Subjects in the experimental condition receive a set reward that will not change regardless of attendance at consecutive sessions. We hypothesize that the participants in the experimental condition will attend more smoking cessation group therapy sessions than those in the control condition because they will have the possibility, although not the likelihood, to obtain contingent reinforcement of greater value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects must be diagnosed with schizophrenia or any other psychotic disorder, bipolar disorder with psychotic features, or major depression with psychotic features according to the electronic medical record.\n* Current nicotine use, defined as smoking 5 or more cigarettes/day for at least 16 of the past 30 days prior to study screening.\n* Prospective subjects must indicate willingness to attend smoking cessation group therapy.\n\nExclusion Criteria:\n\n* Imminent risk for suicide or violence.\n* Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions).\n* Clinically apparent, gross cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT00508560', 'briefTitle': 'Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses', 'orgStudyIdInfo': {'id': 'SUD-Q'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Experimental', 'interventionNames': ['Behavioral: Contingency Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Active Comparator', 'interventionNames': ['Behavioral: Reward']}], 'interventions': [{'name': 'Contingency Management', 'type': 'BEHAVIORAL', 'description': 'Participants draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Tokens include messages of encouragement ("Good job!") or VA canteen vouchers of varying monetary value.', 'armGroupLabels': ['Arm 1']}, {'name': 'Reward', 'type': 'BEHAVIORAL', 'description': 'Participants receive set reward (VA canteen voucher) for each week of smoking cessation treatment they attend. The value of the reward will not change regardless of attendance at consecutive sessions.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Andrew J. Saxon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}