Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-11 @ 7:32 PM
Study NCT ID:
NCT00079469
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2004-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2004-03-08', 'studyFirstSubmitQcDate': '2004-03-09', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['cancer survivor', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Cancer Survivor', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Contingency management is a behavioral treatment approach that provides immediate rewards for positive change in behavior such as quitting smoking. In this protocol, contingency management will be in the form of a cash reward. A smoking cessation (stop-smoking) program that combines contingency management with bupropion and counseling may be effective in helping cancer survivors stop smoking.\n\nPURPOSE: Randomized clinical trial to compare the effectiveness of bupropion and counseling with or without contingency management in helping cancer survivors stop smoking.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the feasibility of a multi-component smoking cessation intervention comprising bupropion and counseling with or without contingency management (cash reward) for cancer survivors who continue to smoke.\n* Compare 7-day point-prevalence abstinence rates in patients treated with these smoking cessation interventions.\n\nSecondary\n\n* Determine the characteristics of these patients that predict success at quitting smoking.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 smoking cessation intervention arms.\n\n* Arm I: Patients receive oral bupropion twice daily on weeks 1-12 and brief practical counseling (i.e., problem-solving strategies, stimulus control, stress management, and social support) on weeks 1-6.\n* Arm II: Patients receive treatment as in arm I and contingency management (i.e., monetary reinforcement for not smoking) on weeks 1-6.\n\nIn both arms, treatment continues in the absence of unacceptable toxicity.\n\nPatients are followed at 12 and 24 weeks after the completion of the smoking cessation interventions.\n\nPROJECTED ACCRUAL: A total of 100 patients (50 per intervention arm) will be accrued for this study within 8 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of cancer at least 6 months before study entry\n\n * No carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or CNS tumor\n* Smoking history of at least 2 years\n\n * Smoked cigarettes daily for the past 30 days\n* Completed prior cancer treatment at least 6 months, but no more than 5 years before study entry\n\n * Concurrent tamoxifen allowed\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Platelet count ≥ 100,000 - 450,000/mm\\^3\n* WBC ≥ 3,000/mm\\^3\n\nHepatic\n\n* AST and ALT ≤ 2 times upper limit of normal\n* Bilirubin ≤ 2.0 mg/dL\n\nRenal\n\n* Creatinine \\< 2.0 mg/dL\n\nCardiovascular\n\n* No unstable cardiovascular disease, including any of the following:\n\n * High-grade atrioventricular block\n * Neurocardiogenic syncope\n * Unstable angina\n * Uncompensated congestive heart failure\n * Poorly controlled hypertension\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Able to undergo peripheral blood draw\n\n * No port-a-cath or Hickman catheters\n* Planning to reside in the Washington D.C. metro area for at least 1 year after study entry\n* Willing to undergo urine testing for cotinine levels and breath testing for carbon monoxide monitoring\n* No significant physical or psychological disability that would preclude study participation\n* No known allergy to bupropion\n* Baseline urine drug screen negative\n\n * Prescribed pain medication allowed\n* None of the following predisposing factors that may increase the risk of seizures with bupropion use:\n\n * History of seizures\n * Alcohol use \\> 4 oz/day\n * History of closed head injury\n * History of an eating disorder\n * CNS infection\n* No poorly controlled diabetes\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* See Disease Characteristics\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 2 years since prior alcohol abuse or substance abuse therapy (except for tobacco use or dependence)\n* More than 14 days since prior monoamine oxidase (MAO) inhibitor\n* No concurrent MAO inhibitor\n* No concurrent bupropion (Wellbutrin® or Wellbutrin SR®)\n* No concurrent alcohol or substance abuse disorder treatment\n* No concurrent nicotine replacement therapy\n* No concurrent medications that lower seizure threshold (e.g., theophylline or short-acting benzodiazepines)\n* No use of tobacco products (more than 1 time per week) other than cigarettes'}, 'identificationModule': {'nctId': 'NCT00079469', 'briefTitle': 'Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial', 'orgStudyIdInfo': {'id': '999903308'}, 'secondaryIdInfos': [{'id': '03-C-N308'}, {'id': 'CDR0000356037'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'smoking cessation intervention', 'type': 'BEHAVIORAL'}, {'name': 'bupropion hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Tobacco Control Research Branch', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'Glen D. Morgan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCI - Division of Cancer Control and Population Science'}, {'name': 'Sandra J. Schaefer, RN, BSN, OCN', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}