Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-06 @ 6:05 PM
Study NCT ID:
NCT00683033
Status:
COMPLETED
Last Update Posted:
2011-11-21
First Post:
2008-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contingency Management for Smoking in Substance Abusers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-17', 'studyFirstSubmitDate': '2008-05-14', 'studyFirstSubmitQcDate': '2008-05-22', 'lastUpdatePostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cigarette smoking abstinence.', 'timeFrame': 'Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contingency Management', 'Cigarette Smoking Cessation', 'Substance Abusers'], 'conditions': ['Cigarette Smoking']}, 'descriptionModule': {'briefSummary': 'Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking during the second session each day, and setting a quit date. After these sessions, participants will be randomly assigned to one of two 4-week conditions: (a) standard care or (b) standard care plus prize CM for smoking abstinence with the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed throughout the intervention. Follow-up data will be collected through 6-months post-quit date.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current alcohol, cocaine, marijuana, or opiate abuse or dependence\n* smoke ≥ 10 cigarettes per day\n* expired CO \\> 8 ppm\n* self-reported interest in quitting smoking,\n* ≥ 18 years old\n* willing to provide names, addresses and phone numbers of individuals to assist in locating the participant for follow-up evaluations,\n* English speaking\n\nExclusion Criteria:\n\n* currently receiving behavioral therapy or pharmacotherapy for smoking plan to use pharmacotherapy in this quit attempt\n* serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, suicide risk)\n* cognitive impairment\n* in recovery for pathological gambling'}, 'identificationModule': {'nctId': 'NCT00683033', 'acronym': 'R21', 'briefTitle': 'Contingency Management for Smoking in Substance Abusers', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Contingency Management for Smoking in Substance Abusers', 'orgStudyIdInfo': {'id': '08-081-2'}, 'secondaryIdInfos': [{'id': 'R21DA021836-01A2', 'link': 'https://reporter.nih.gov/quickSearch/R21DA021836-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Brief counseling based on public health service guidelines.', 'interventionNames': ['Behavioral: Brief smoking cessation counseling']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Brief counseling based on public health service guidelines for quitting smoking plus prize-based contingency management', 'interventionNames': ['Behavioral: Contingency Management', 'Behavioral: Brief smoking cessation counseling']}], 'interventions': [{'name': 'Contingency Management', 'type': 'BEHAVIORAL', 'description': 'For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking is delivered. Expired carbon monoxide (CO) tests are conducted twice daily and urinary cotinine tests are conducted once each week. Participants earn the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL).', 'armGroupLabels': ['B']}, {'name': 'Brief smoking cessation counseling', 'type': 'BEHAVIORAL', 'description': 'For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking. Expired carbon monoxide tests are conducted twice daily and urinary cotinine tests are conducted once each week.', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Sheila M Alessi, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}