Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02002858
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smoking Cessation for Depression and Anxiety Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-06', 'studyFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Status using the Timeline Follow-Back Assessment', 'timeFrame': 'Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.', 'description': 'Participants will report the number of cigarettes they consumed everyday since their last visit. The number of cigarettes reported will be used to determine smoking status (e.g., 0 cigarettes reported is abstinent and any cigarettes reported is currently smoking).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['smoking', 'cessation', 'anxiety', 'anxious', 'depression', 'depressed', 'smoker', 'stress'], 'conditions': ['Smoking', 'Anxiety Disorders', 'Depression Disorders']}, 'descriptionModule': {'briefSummary': 'The primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation, and anxiety and depression management treatment program (SDAT). Both treatments also utilize nicotine replacement therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-65 years old\n* Capable of providing informed consent\n* Willing to attend all study visits and comply with the protocol\n* Daily smoker for at least one year\n* Currently smoke an average of at least 6 cigarettes per day\n* Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale\n* Elevated anxiety or depression\n\nExclusion Criteria:\n\n* Use of other tobacco products\n* Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol\n* Currently suicidal or high suicide risk\n* Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt\n* Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression\n* Current or intended participation in a concurrent substance abuse treatment\n* Current non-nicotine substance dependence\n* Insufficient command of English to participate in assessment or treatment'}, 'identificationModule': {'nctId': 'NCT02002858', 'acronym': 'SDAT', 'briefTitle': 'Smoking Cessation for Depression and Anxiety Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Integrated Smoking Cessation Treatment for Emotional Dysregulation', 'orgStudyIdInfo': {'id': '1R34DA03474101'}, 'secondaryIdInfos': [{'id': 'R34DA034741', 'link': 'https://reporter.nih.gov/quickSearch/R34DA034741', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Depression and Anxiety Smoking Cessation Treatment', 'description': 'Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies', 'interventionNames': ['Drug: Nicotine Patch', 'Behavioral: Depression and Anxiety Smoking Cessation Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational-Support Psychotherapy', 'description': 'Educational-based psychotherapy and standard smoking cessation treatment program', 'interventionNames': ['Drug: Nicotine Patch', 'Behavioral: Educational-Support Psychotherapy']}], 'interventions': [{'name': 'Nicotine Patch', 'type': 'DRUG', 'armGroupLabels': ['Depression and Anxiety Smoking Cessation Treatment', 'Educational-Support Psychotherapy']}, {'name': 'Depression and Anxiety Smoking Cessation Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['SDAT'], 'description': 'Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies', 'armGroupLabels': ['Depression and Anxiety Smoking Cessation Treatment']}, {'name': 'Educational-Support Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Educational-based psychotherapy and standard smoking cessation treatment program', 'armGroupLabels': ['Educational-Support Psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77201', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Anxiety and Health Research Laboratory and Substance Use Treatment Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Michael J Zvolensky, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hugh Roy and Lillie Cranz Cullen Distinguished University Professor', 'investigatorFullName': 'Michael J. Zvolensky, Ph.D.', 'investigatorAffiliation': 'University of Houston'}}}}