Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
NCT ID: NCT02048917
Last Updated: 2020-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
93 participants
INTERVENTIONAL
2014-07-22
2019-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + bupropion
High Intensity Counseling + bupropion
High Intensity Counseling + bupropion
High Intensity Counseling + bupropion
High Intensity Counseling + varenicline
High Intensity Counseling + varenicline
High Intensity Counseling + varenicline
High Intensity Counseling + varenicline
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + bupropion
Low Intensity Counseling + bupropion
Low Intensity Counseling + bupropion
Low Intensity Counseling + bupropion
Low Intensity Counseling + varenicline
Low Intensity Counseling + varenicline
Low Intensity Counseling + varenicline
Low Intensity Counseling + varenicline
Interventions
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High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + bupropion
High Intensity Counseling + bupropion
High Intensity Counseling + varenicline
High Intensity Counseling + varenicline
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + bupropion
Low Intensity Counseling + bupropion
Low Intensity Counseling + varenicline
Low Intensity Counseling + varenicline
Eligibility Criteria
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Inclusion Criteria
* Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:
1. Lung or Bronchus cancer or Head \& Neck, cancers (all sites).
2. Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
3. Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies \[laser ablation,cervical conization, LEEP\].
* Having smoked at least 1 cigarette within 4 weeks of study enrollment.
* Having at least a 10-pack year history of cigarette smoking.
* Having smoked at least one cigarette within 1 month of cancer diagnosis.
* Life expectancy is greater than 1 year.
* Patient has an AUDIT score of \< 10.
* Patient has ECOG Performance Status of \<=2.
* Patients must have the ability to understand and the willingness to provide signed written informed consent document.
Exclusion Criteria
* History of suicide attempt or preparation for attempt within the past 10 years.
* C-SRSS Baseline/Screening:
1. Patient response of "Yes" to any question except question 1.
2. Patient response of "Yes" to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation.
* Hospitalized for psychiatric illness within the past two years.
* History of Bipolar disorder.
* Currently taking Bupropion for depression.
* Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks.
* History of eating disorder such as anorexia or bulimia.
* Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
* History of epilepsy or seizure disorder.
* Active severe kidney or liver disease.
* Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use method of contraception during and for 30 days following last cessation drug dose.
* Patients within three months of a myocardial infarction.
* Patients with unstable angina or serious arrhythmia.
* Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake.
* Patient taking varenicline or bupropion within one month of study enrollment.
* Participation in any other investigational drug study within 4 weeks of study enrollment.
* Currently enrolled in other professional tobacco cessation therapeutic intervention.
* Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site PI to determine that there are no drug interactions concerns.
18 Years
ALL
No
Sponsors
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Kentucky Lung Cancer Research Program
OTHER
University of Kentucky
OTHER
Responsible Party
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Joseph Valentino
Study Chair
Principal Investigators
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Joseph Valentino, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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King's Daughters Medical Center
Ashland, Kentucky, United States
Hardin Memorial Health Cancer Care Center
Elizabethtown, Kentucky, United States
ARH Cancer Center
Hazard, Kentucky, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Lexington Veterans Affair Medical Center
Lexington, Kentucky, United States
University Of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States
St. Claire Regional Medical Center
Morehead, Kentucky, United States
Owensboro Health
Owensboro, Kentucky, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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References
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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Other Identifiers
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KCTN-1301
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-13-MULTI-13-KCTN-1301
Identifier Type: -
Identifier Source: org_study_id
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