Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01623505
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2011-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-03-31', 'releaseDate': '2022-06-21'}], 'estimatedResultsFirstSubmitDate': '2022-06-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D009330', 'term': 'Nebulizers and Vaporizers'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 738}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2011-07-13', 'studyFirstSubmitQcDate': '2012-06-19', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks.', 'timeFrame': '5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome will include withdrawal and neuropsychiatric symptoms (e.g., depression, anxiety, suicidal ideation, anger/aggression). These variables will be measured at 1, 3, 5, 8, 10, 22, and 52 weeks following the target quit date.', 'timeFrame': '1, 3, 5, 8, 10, 22, and 52 weeks post target quit date'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Psychiatric Illness', 'Pharmacotherapy'], 'conditions': ['Smoking Cessation', 'Psychiatric Illness']}, 'referencesModule': {'references': [{'pmid': '18263663', 'type': 'BACKGROUND', 'citation': 'Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.'}, {'pmid': '16820546', 'type': 'BACKGROUND', 'citation': 'Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.'}, {'pmid': '14678060', 'type': 'BACKGROUND', 'citation': 'Hughes JR, Keely J, Naud S. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004 Jan;99(1):29-38. doi: 10.1111/j.1360-0443.2004.00540.x.'}, {'pmid': '18617085', 'type': 'BACKGROUND', 'citation': 'Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.'}, {'pmid': '18028247', 'type': 'BACKGROUND', 'citation': 'Stapleton JA, Watson L, Spirling LI, Smith R, Milbrandt A, Ratcliffe M, Sutherland G. Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness. Addiction. 2008 Jan;103(1):146-54. doi: 10.1111/j.1360-0443.2007.02083.x. Epub 2007 Nov 19.'}, {'pmid': '11086367', 'type': 'BACKGROUND', 'citation': 'Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness: A population-based prevalence study. JAMA. 2000 Nov 22-29;284(20):2606-10. doi: 10.1001/jama.284.20.2606.'}, {'pmid': '12745505', 'type': 'BACKGROUND', 'citation': 'Warner KE, Burns DM. Hardening and the hard-core smoker: concepts, evidence, and implications. Nicotine Tob Res. 2003 Feb;5(1):37-48. doi: 10.1080/1462220021000060428.'}, {'pmid': '15520358', 'type': 'BACKGROUND', 'citation': 'Grant BF, Hasin DS, Chou SP, Stinson FS, Dawson DA. Nicotine dependence and psychiatric disorders in the United States: results from the national epidemiologic survey on alcohol and related conditions. Arch Gen Psychiatry. 2004 Nov;61(11):1107-15. doi: 10.1001/archpsyc.61.11.1107.'}, {'pmid': '16295704', 'type': 'BACKGROUND', 'citation': "Slovinec D'Angelo ME, Reid RD, Hotz S, Irvine J, Segal RJ, Blanchard CM, Pipe A. Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial. Am J Health Promot. 2005 Nov-Dec;20(2):127-34. doi: 10.4278/0890-1171-20.2.127."}, {'pmid': '37335995', 'type': 'DERIVED', 'citation': 'Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.'}, {'pmid': '27233840', 'type': 'DERIVED', 'citation': 'Tulloch HE, Pipe AL, Els C, Clyde MJ, Reid RD. Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial. BMC Med. 2016 Jun 7;14:80. doi: 10.1186/s12916-016-0626-2.'}, {'pmid': '26711162', 'type': 'DERIVED', 'citation': 'Tulloch HE, Pipe AL, Clyde MJ, Reid RD, Els C. The Quit Experience and Concerns of Smokers With Psychiatric Illness. Am J Prev Med. 2016 Jun;50(6):709-718. doi: 10.1016/j.amepre.2015.11.006. Epub 2015 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'Research Aims\n\nThe aims of this research study are:\n\n1. To determine which of the following three smoking cessation medications is most effective in achieving cessation:\n\n * Nicotine Patch\n * Nicotine Patch + gum or inhaler\n * Varenicline (Champix;\n2. To investigate how often participants experience neuropsychiatric symptoms over the course of their cessation attempt and to assess whether:\n\n * They occur more often when taking one medication versus another\n * They occur more often in those with or without psychiatric illnesses.\n\nHypotheses to be Tested\n\nThe hypotheses to be tested include the following:\n\n1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target quit date will be significantly higher in smokers receiving long-term transdermal NRT in combination with other NRT products or those receiving varenicline compared to those receiving transdermal NRT alone.\n2. Some participants will experience neuropsychiatric symptoms during their cessation attempt, and those in the varenicline group will experience a greater incidence of neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or in combination with other NRT products. Patients with psychiatric illnesses will report higher levels of withdrawal symptoms than those without psychiatric illnesses.', 'detailedDescription': 'Participants will be recruited from the UOHI Smoking Cessation Clinic and via media advertisements. Following the baseline assessment, participants will be randomly assigned to one of three groups:\n\n1. 10-week standard regimen of transdermal NRT (NRT);\n2. Long duration of transdermal NRT in combination with other NRT products (NRT+); or\n3. Varenicline (VR).\n\nParticipants assigned to the "NRT" standard regimen group will follow a 10-week treatment of nicotine patches alone.\n\nParticipants assigned to the "NRT+" long-duration group will follow the same regimen as the NRT group, but will not be limited to a fixed declining dose strategy, nor limited to a 10-week duration (potential maximum dosage of 35mg/day and maximum treatment duration of up to 22 weeks). Participants will also be provided with other NRT products (i.e., gum or inhaler).\n\nParticipants assigned to the "VR" group will start the medication on the day of the baseline assessment and set a target quit date any time within the 8 to 14 day period after baseline. Participants will receive a 12-week supply of varenicline with a possible extension of up to 24 weeks.\n\nAll participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation in accordance with nursing best-practice guidelines. These sessions occur at 1, 3, 5, 8, and 10 weeks post target quit date. Counselling sessions will focus on practical counselling (problem solving and skills training) and social support.\n\nDuring the treatment phase, participants will complete questionnaires measuring withdrawal and neuropsychiatric symptoms at 1, 3, 5, 8, and 10 weeks. These questionnaires will also be completed at 22 and 52 weeks after the target quit date.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is a current smoker (≥ 10 cigarettes per day in the preceding\\\\ six months);\n* Participant is willing to make a quit attempt in the 2-4 weeks after initial screening for eligibility;\n* Participant is 18 years of age and older;\n* Participant is willing to provide informed consent.\n\nExclusion Criteria:\n\n* Participant is currently using or has used any intervention medications in the previous 6 months (i.e, Champix (varenicline); and/or Nicotine replacement therapy (patch, gum, inhaler, lozenge));\n* Participant has contraindication(s) to any of the following smoking cessation medications:\n\n * Nicotine replacement therapy (allergic reaction to adhesive; serious cardiac arrhythmias (e.g., tachycardia); participant is during the immediate post-myocardial infarction period (i.e. incident has occurred within the last 10 days); severe or worsening angina pectoris; participant has had a recent cerebral vascular accident);\n * Varenicline (end-stage renal disease; use of cimetidine (by participants with severe renal impairment); previous allergic reaction to varenicline);\n* Pregnant or breastfeeding women or those intending to become pregnant in the next year;\n* Current or previous (in the last 3 months) substance abuse;\n* Unable to provide informed consent due to unstable psychiatric symptoms (e.g., active, untreated psychosis or suicidality);\n* Participant is unable to read and understand English or French;\n* In order to prevent contamination across groups, only one person per household may participate.'}, 'identificationModule': {'nctId': 'NCT01623505', 'acronym': 'RW', 'briefTitle': 'Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Interventions for Cardiovascular Disease: "Real-World" Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation', 'orgStudyIdInfo': {'id': 'HIPRC-6614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Champix', 'interventionNames': ['Drug: Champix']}, {'type': 'EXPERIMENTAL', 'label': 'Long & Combination patch treatment', 'interventionNames': ['Drug: Transdermal Nicoderm patch combined with gum or inhaler']}, {'type': 'EXPERIMENTAL', 'label': 'Standard patch treatment', 'interventionNames': ['Drug: Transdermal Nicoderm patch']}], 'interventions': [{'name': 'Champix', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': 'Participants receiving this treatment will start the medication on the day of the baseline assessment and set a target quit date within the 8 to 14 day period after baseline. Participants in this group will receive a 12-week supply of varenicline. Treatment will begin 2 weeks before the target quit date and continue for 10 weeks after the target quit date. Participants will be prescribed 0.5 mg once daily for 3 days, 0.5 mg twice daily for 4 days, and 1 mg twice daily for 11 weeks. Participants will be given the option of extending their treatment to a maximum of up to 24 weeks of varenicline.\n\nAll participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.', 'armGroupLabels': ['Champix']}, {'name': 'Transdermal Nicoderm patch combined with gum or inhaler', 'type': 'DRUG', 'otherNames': ['Habitrol'], 'description': 'Participants receiving this treatment will set a quit date within 2 weeks after baseline assessment and apply the patch on that day. This group will follow the same regimen as the "standard patch treatment", but is not limited to a fixed dosing strategy. Participants will be advised on the titration of patch (increase or decrease in dosage) to ensure elimination of withdrawal symptoms (maximum dosage of 35mg/day, maximum treatment of up to 22 weeks). Participants will be provided with either gum or inhaler to manage cravings.\n\nAll participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.\n\n\\*Off-label dosage approved by Health Canada via "No Objection" letter.', 'armGroupLabels': ['Long & Combination patch treatment']}, {'name': 'Transdermal Nicoderm patch', 'type': 'DRUG', 'otherNames': ['Habitrol'], 'description': "Participants receiving this treatment group (standard treatment)will set a target quit date within the 2 weeks after baseline assessment and start to apply the patch on that day. This treatment will consist of a 10-week supply of nicotine patches. The initial dosage will be determined from the average number of cigarettes smoked each day as per the manufacturer's recommendation. Participants smoking ≥ 20 cigarettes per day will be prescribed 21 mg/24 hours for 6 weeks, 14 mg/24 hours for 2 weeks, and 7 mg/24 hours for 2 weeks. Participants smoking 11 - 20 cigarettes per day will be prescribed 14 mg/24 hours for 6 weeks, and 7 mg/24 hours for 4 weeks.\n\nAll participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.", 'armGroupLabels': ['Standard patch treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Insitute - Prevention and Wellness Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Heather E Tulloch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'Andrew Pipe, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'Robert Reid, MBA PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'Charl Els, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Ontario', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heather Tulloch', 'investigatorAffiliation': 'Ottawa Heart Institute Research Corporation'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-06-21', 'type': 'RELEASE'}, {'date': '2023-03-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ottawa Heart Institute Research Corporation'}}}}