Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-24 @ 4:52 AM
Study NCT ID:
NCT02051803
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2014-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Women Engaging in Quitting Smoking Together (WE QUIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'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': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-30', 'studyFirstSubmitDate': '2014-01-30', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Point prevalence abstinence from smoking', 'timeFrame': '6 months from smoking quit date', 'description': 'We will compare the percentage of participants in each treatment group who report abstinence from smoking for the 7 days prior to each follow-up assessment (1-, 3-, and 6-months post-quit date).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking cessation', 'women'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The long-term goal of this program of research is to develop and disseminate an efficacious intervention for weight concern that will significantly increase smoking cessation rates among women. The overall objective of this project is to develop this intervention and modify it based on piloting and feedback to ensure its feasibility and acceptability. These objectives will be accomplished by pursuing the following specific aim: 1) develop a group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a comparison health education (HE) program and pilot both treatments with three groups of 10 (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* 18 to 65 years of age\n* smoke 10 or more cigarettes per day\n* daily smoker for at least the past year\n* report motivation to quit smoking in the next month of at least 5 on a 10 point scale\n* report concern of at least 50 on at least one of two 100 point scales assessing weight concern\n* able to travel to study location for study appointments\n\nExclusion Criteria:\n\n* current use of other smoking cessation or weight loss therapies\n* current use of other tobacco products at least weekly\n* current diagnosis of depression\n* diagnosis or treatment for non-nicotine substance use disorder with substance use during the past 6 months\n* lifetime diagnosis or treatment of eating disorder, bipolar disorder, schizophrenia, or schizoaffective disorder\n* current use of psychotropic medication except antidepressants\n* score above established cut-offs on self-report screening measures of depressive symptomology, eating disorder symptomology, alcohol use disorder, or drug use disorder\n* current suicidality or homicidality\n* medical condition that is a contraindication for the use of transdermal nicotine patch\n* lives at same address as current or past participant'}, 'identificationModule': {'nctId': 'NCT02051803', 'acronym': 'WE QUIT', 'briefTitle': 'Women Engaging in Quitting Smoking Together (WE QUIT)', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women', 'orgStudyIdInfo': {'id': '1303-003'}, 'secondaryIdInfos': [{'id': 'K23DA035288', 'link': 'https://reporter.nih.gov/quickSearch/K23DA035288', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Distress Tolerance Treatment for Weight Concern (DT-W)', 'description': 'DT-W is delivered over a 9 week period with 1 1-hr individual session during week 1, 8 weekly 1.5-hr group counseling sessions during weeks 2-9, and 1 20-minute individual telephone session during week 4. Session content includes distress tolerance intervention for weight concern plus standard behavioral smoking cessation treatment. Participants also receive 8 weeks of nicotine patch.', 'interventionNames': ['Behavioral: Distress Tolerance Treatment for Weight Concern (DT-W)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education (HE)', 'description': 'HE is delivered over a 9 week period with 1 1-hr individual session during week 1, 8 weekly 1.5-hr group counseling sessions during weeks 2-9, and 1 20-minute individual telephone session during week 4. Session content includes smoking health education program plus standard behavioral smoking cessation treatment. Participants also receive 8 weeks of nicotine patch.', 'interventionNames': ['Behavioral: Health Education (HE)']}], 'interventions': [{'name': 'Distress Tolerance Treatment for Weight Concern (DT-W)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Distress Tolerance Treatment for Weight Concern (DT-W)']}, {'name': 'Health Education (HE)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Health Education (HE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Erika L. Bloom, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital and Rhode Island Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}