Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-26 @ 11:29 PM
Study NCT ID:
NCT00757068
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2008-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategies to Avoid Returning to Smoking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2008-09-19', 'studyFirstSubmitQcDate': '2008-09-19', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence at 12 months postpartum', 'timeFrame': 'through 12 months'}], 'secondaryOutcomes': [{'measure': 'Explore factors associated with abstinence postpartum.', 'timeFrame': '0-12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-smoking', 'Women', 'Pregnancy', 'Treatment', 'Mood', 'Weight', 'Supportive', 'Adjustment'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '31219152', 'type': 'DERIVED', 'citation': 'Levine MD, Emery RL, Kolko Conlon RP, Marcus MD, Germeroth LJ, Salk RH, Cheng Y. Depressive Symptoms Assessed Near the End of Pregnancy Predict Differential Response to Postpartum Smoking Relapse Prevention Intervention. Ann Behav Med. 2020 Jan 24;54(2):119-124. doi: 10.1093/abm/kaz026.'}, {'pmid': '26998789', 'type': 'DERIVED', 'citation': 'Levine MD, Cheng Y, Marcus MD, Kalarchian MA, Emery RL. Preventing Postpartum Smoking Relapse: A Randomized Clinical Trial. JAMA Intern Med. 2016 Apr;176(4):443-52. doi: 10.1001/jamainternmed.2016.0248.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relative efficacy of a postpartum smoking relapse prevention program, Strategies to Avoid Returning to Smoking (STARTS), and a supportive, nondirective comparison condition (SUPPORT) to increase the proportion of women who remain abstinent through 12 months postpartum. We hypothesize that women randomized to STARTS will maintain higher rates of smoking abstinence at 6 and 12 months postpartum, and expect STARTS to increase the length of time abstinence is sustained relative to SUPPORT.', 'detailedDescription': 'The goal of the proposed investigation is to determine whether a cognitive behavioral relapse prevention intervention designed to address mood and weight concerns during the postpartum period will decrease the rate of postpartum relapse to smoking. We propose a two-group, randomized controlled trial. Women who quit smoking as a result of pregnancy, have been quit for at least one month prior to delivery and are motivated to remain abstinent postpartum will complete baseline assessments and be randomly assigned during the third trimester of pregnancy to either a cognitive behavioral relapse prevention intervention specifically designed for women who quit smoking during pregnancy, Strategies to Avoid Returning To Smoking (STARTS), or a nonspecific, supportive condition (SUPPORT). Both conditions will receive written information on the dangers of postpartum smoking and an equivalent number and amount of sessions immediately prior to delivery and during the first six months postpartum. Women will be treated for the first six months postpartum because substantial evidence has shown the risk of relapse to be greatest during the six months immediately following delivery (McBride et al., 1990; Mullen et al., 1990). All women will complete assessments at baseline (during pregnancy) and 3, 6 and 12 months postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women will be eligible to participate if they:\n\n * report having smoked daily for at least one month during the 3 months prior to becoming pregnant;\n * smoked at least 10 cigarettes per day before quitting;\n * report no smoking in the four weeks prior to enrollment;\n * are not currently smoking as verified by a CO less than 8ppm;\n * are at least 'somewhat' motivated to remain abstinent postpartum and\n * are at least 14 years of age.\n\nExclusion Criteria:\n\n* Women with current, acute psychiatric disorders, including other substance use problems and symptoms that warrant immediate treatment will be referred for care and excluded from this trial.\n* Women with psychiatric disorders (e.g., depressive or anxiety disorders), who are not acutely suicidal and in whom the symptoms are not severe enough to preclude participation in a randomized trial, will be eligible to participate. However, women taking psychiatric medications that may affect the mediators of treatment, such as antidepressant, anxiolytic or weight control medications, will be excluded from participation.\n* Women who endorse current suicidality will be discussed immediately with the consulting physician and referred to the psychiatric emergency room for further evaluation as indicated."}, 'identificationModule': {'nctId': 'NCT00757068', 'acronym': 'STARTS', 'briefTitle': 'Strategies to Avoid Returning to Smoking', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation', 'orgStudyIdInfo': {'id': 'LEVINER01'}, 'secondaryIdInfos': [{'id': 'R01DA021608', 'link': 'https://reporter.nih.gov/quickSearch/R01DA021608', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SBT', 'description': 'Women assigned to SBT (blue) will receive a six month program that offers to help them stay quit after having a baby.', 'interventionNames': ['Behavioral: Supportive Behavioral Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'CBT', 'description': 'Women assigned to CBT (pink) will receive a six month treatment designed to provide support and address the concerns of women who have just had a baby and do not want to resume smoking.', 'interventionNames': ['Behavioral: CBT addressing postpartum mood and weight concerns']}], 'interventions': [{'name': 'CBT addressing postpartum mood and weight concerns', 'type': 'BEHAVIORAL', 'otherNames': ['STARTS', 'Strategies to Avoid Returning to Smoking'], 'description': 'Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. In these treatment sessions, the counselor will address postpartum mood and weight concerns.', 'armGroupLabels': ['CBT']}, {'name': 'Supportive Behavioral Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Smoking cessation', 'General'], 'description': 'Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. A non-specific, supportive condition will be delivered to women who want to remain smoke-free after they give birth.', 'armGroupLabels': ['SBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Michele D Levine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}