Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT02905656
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategies to Promote Cessation in Smokers Who Are Not Ready To 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003419', 'term': 'Crisis Intervention'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-01', 'size': 2984413, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-30T10:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 903}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Point Prevalence Tobacco Abstinence', 'timeFrame': '12 months from randomization', 'description': 'Point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials.'}], 'secondaryOutcomes': [{'measure': 'Prolonged Tobacco Abstinence', 'timeFrame': '12 months from randomization', 'description': 'Prolonged abstinence will be defined as continuous abstinence from the point of initial cessation (with a two week grace period around the cessation date).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['quitline', 'nicotine replacement therapy', 'tobacco intervention', 'smokers not ready to quit'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '34985171', 'type': 'DERIVED', 'citation': 'Derefinko KJ, Bursac Z, Hand SB, Ebbert JO, Womack C, Klesges RC. Planning a Change Easily (PACE) for smokers who are not ready to quit: a telephone-based, randomized controlled trial. Addiction. 2022 Jun;117(6):1748-1757. doi: 10.1111/add.15796. Epub 2022 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'To our knowledge, no study has evaluated the independent effects of motivational interviewing and rate reduction, individually versus in combination, for motivating smokers who are not ready to quit (SNRTQ) to increase both quit attempts and tobacco abstinence. Given the disseminability and the fact that findings can be readily translated into the network of tobacco quitlines, we propose: (1) To test a tobacco quitline for SNRTQ, following methods that we have previously implemented and evaluated (HL-123978, CA-127964); (2) To randomize 828 SNRTQs to: (a) Brief Advice + typical smoking cessation resources (control group); (b) motivational interviewing format recommended by the Clinical Practice Guidelines; (c) behavioral and pharmacologic rate reduction, and (d) both motivational interviewing and behavioral and pharmacologic rate reduction. This design allows us to evaluate the independent and additive effects of motivational interviewing and rate reduction on quit attempts and smoking cessation.\n\nWe plan to evaluate the efficacy of the intervention utilizing point prevalence at the 12-month follow-up. The Society for Research in Nicotine and Tobacco consensus paper concluded that point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials. Prolonged abstinence at the 12-month follow-up and quit attempts at the 2-, 4- and 6-month and the 12-month follow-up are secondary endpoints. Self-efficacy, level of smoking reduction, tobacco dependence, intentions, motivation, and confidence to quit, and intervention adherence (# sessions attended, amount of nicotine replacement therapy used) will be tested as important treatment mediators.', 'detailedDescription': "On the Society for Research in Nicotine and Tobacco definition of a cessation induction trial, which is a treatment that promotes cessation among all smokers, including those not ready to quit.1 One implication of this design is that success is based on percent abstinent at a given point in time and do not tie a follow-up to a determined quit date (since smokers not ready to quit often don't typically set formal quit dates).\n\nInvestigators research led to a four condition treatment design as the main independent variable of interest. Participants will be randomly assigned to four treatment conditions: (1) Brief advice; (2) motivational interviewing; (3) rate reduction; and (4) combination of motivational interviewing and rate reduction. All four intervention conditions will receive three sessions once a week, ideally, but can extend to a 6 week time period, each approximately 30 minutes in length, provided over a period of 4 to 6 weeks, depending on the participant's circumstances. Upon the completion of the main components, Booster sessions will be administered in 2-month increments throughout the intervention period (2 month, 4 month, \\& 6 month follow-up) in conjunction with study assessments. The window for the Booster sessions will be as indicated above 2M, 4M, and 6M after enrollment, but we will continue to try and reach them to complete the booster session for 4 weeks. For example, 2 month booster window opens at 8 weeks after enrollment and we will try to complete that 2 month booster within 4 weeks. Twelve months after randomization, prolonged abstinence will be measured."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand English\n* For the past 12 months, has smoked 5 or more cigarettes a day\n* 18 years or older\n* Planning on Quitting smoking someday\n* Access to a telephone\n* Willing and able to use NRT in the form of gum\n* Not currently using chantix or wellbutrin\n\nExclusion Criteria:\n\n* Planning to quit smoking cigarettes in the next 30 days\n* Currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months\n* Currently using chantix or wellbutrin\n* Diagnosed with an unstable heart condition'}, 'identificationModule': {'nctId': 'NCT02905656', 'acronym': 'PACE', 'briefTitle': 'Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit (PACE)', 'orgStudyIdInfo': {'id': '15-04215-XP 0027114'}, 'secondaryIdInfos': [{'id': '1R01CA193245-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA193245-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Brief Advice', 'description': 'Participants will receive brief advice to quit smoking, and be provided psycho-education citing health consequences and the positive impact on mortality and morbidity.', 'interventionNames': ['Behavioral: Brief Advice']}, {'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing (MI)', 'description': "Motivational interviewing (MI) is a collaborative conversation style for strengthening a person's own motivation and commitment to change. MI attempts to avoid a confrontational style and, instead, guides participants toward choosing to make a change in their behavior.", 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'EXPERIMENTAL', 'label': 'Rate Reduction (RR)', 'description': 'Participants will be informed of the strong medical evidence of systematic reductions in smoking behavior can lead to long-term smoking cessation. This condition will receive Nicotine Replacement Therapy in the form of gum.', 'interventionNames': ['Behavioral: Rate Reduction', 'Drug: Pharmacological']}, {'type': 'EXPERIMENTAL', 'label': 'MI + RR', 'description': 'In this intervention, participants receive both the skills based rate reduction intervention and the more motivationally based MI intervention. This condition will receive Nicotine Replacement Therapy in the form of gum.', 'interventionNames': ['Drug: Pharmacological', 'Behavioral: MI+RR']}], 'interventions': [{'name': 'Brief Advice', 'type': 'BEHAVIORAL', 'description': 'Psychoeducation', 'armGroupLabels': ['Brief Advice']}, {'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'Guides participants toward choosing to make a change in their behavior with a collaborative conversation.', 'armGroupLabels': ['Motivational Interviewing (MI)']}, {'name': 'Rate Reduction', 'type': 'BEHAVIORAL', 'description': 'Reducing the number of cigarettes consumed.', 'armGroupLabels': ['Rate Reduction (RR)']}, {'name': 'Pharmacological', 'type': 'DRUG', 'description': 'Nicotine Replacement Therapy in the form of gum.', 'armGroupLabels': ['MI + RR', 'Rate Reduction (RR)']}, {'name': 'MI+RR', 'type': 'BEHAVIORAL', 'description': 'Combination of reducing the number of cigarettes consumed while guiding the participant to make a change in their behavior.', 'armGroupLabels': ['MI + RR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Robert Klesges, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of Tennessee', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Public Health Sciences', 'investigatorFullName': 'Robert Klesges', 'investigatorAffiliation': 'University of Virginia'}}}}