Varenicline Tartrate With Telephone-Based Counseling and/or Internet-Based Counseling in Helping Adults Stop Smoking
NCT ID: NCT00301145
Last Updated: 2013-12-19
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
NA
1200 participants
INTERVENTIONAL
2005-10-31
2008-11-30
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well giving varenicline tartrate together with a telephone-based counseling program and/or an Internet-based counseling program works in helping adults stop smoking.
Detailed Description
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* Determine the effectiveness of varenicline with telephone counseling vs Internet-based counseling vs telephone counseling and Internet-based smoking cessation interventions in adult smokers.
* Determine individual or group differences in patients undergoing these interventions.
* Determine heterogeneity in responsiveness in regard to the Classification and Regression Tree Analysis in patients undergoing these interventions.
* Determine the effectiveness of these interventions in regard to recruitment, implementation, barriers to treatment, exposure to intervention, satisfaction with treatment, treatment contamination, and program maintenance.
* Determine the cost-effectiveness of these interventions.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 3 intervention arms.
* Arm I: Patients undergo a proactive telephone-based (PTB) smoking cessation program.
* Arm II: Patients undergo a web-based (WB) smoking cessation program.
* Arm III: Patients undergo an integrated PTB/WB smoking cessation program. Beginning 1 week before the target quit date, all patients receive oral varenicline once daily for 3 days and then twice daily for up to 12 weeks. They also receive a mailed packet containing a welcome letter, description of the intervention services offered, a privacy notice, a Free \& Clear Quit Kit (comprehensive education/self-help materials including health smoking substitutions), a phone call to orient the patient to the intervention to which they are randomized, and access to a toll-free support line. All patients undergo a pre-treatment assessment (pre-quit) and 3 post-quit assessments at 21 days, 12 weeks, and 6 months after their original scheduled quit date to determine medication adherence, treatment utilization, point-prevalent smoking outcomes, and continuous nonsmoking.
PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
NONE
Interventions
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smoking cessation intervention
varenicline
counseling intervention
internet-based intervention
Eligibility Criteria
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Inclusion Criteria
* No prior participation in GHC's Free \& Clear smoking cessation program within the past 6 months
PATIENT CHARACTERISTICS:
* In good general health
* Sufficient verbal and written English
* Dependable access to a telephone and the Internet
* Not currently drinking ≥ 14 alcoholic drinks per week and/or binge drinking ≥ 2 times in the past month
* Not pregnant or nursing
* No plan to become pregnant
* No severe chronic heart disease (e.g, myocardial infarction within the past 3 months)
* No severe chronic obstructive pulmonary disease that ever required hospitalization or oxygen treatment
* No diagnosis of or treatment for a psychotic disorder (e.g., schizophrenia, bipolar disorder, or mania)
* Not having certain kidney problems
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent use of medications contraindicated with bupropion hydrochloride or known to lower seizure threshold (e.g., antidepressant, antipsychotic, monamine oxidase inhibitor, or protease inhibitor)
* No concurrent use of recreational or street drugs
* No concurrent use of bupropion hydrochloride or nicotine replacement therapy
* No concurrent cimetidine, metformin, phenformin, pindolol, procainamide
* Not on dialysis
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SRI International
INDUSTRY
Principal Investigators
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Gary E. Swan, PhD
Role: STUDY_CHAIR
SRI International
Locations
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SRI International
Menlo Park, California, United States
Center for Health Studies
Seattle, Washington, United States
Free & Clear, Incorporated
Seattle, Washington, United States
Countries
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References
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Nishita DM, Jack LM, McElroy M, McClure JB, Richards J, Swan GE, Bergen AW. Clinical trial participant characteristics and saliva and DNA metrics. BMC Med Res Methodol. 2009 Oct 29;9:71. doi: 10.1186/1471-2288-9-71.
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
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.
Swan GE, Javitz HS, Jack LM, Wessel J, Michel M, Hinds DA, Stokowksi RP, McClure JB, Catz SL, Richards J, Zbikowski SM, Deprey M, McAfee T, Conti DV, Bergen AW. Varenicline for smoking cessation: nausea severity and variation in nicotinic receptor genes. Pharmacogenomics J. 2012 Aug;12(4):349-58. doi: 10.1038/tpj.2011.19. Epub 2011 May 24.
Catz SL, Jack LM, McClure JB, Javitz HS, Deprey M, Zbikowski SM, McAfee T, Richards J, Swan GE. Adherence to varenicline in the COMPASS smoking cessation intervention trial. Nicotine Tob Res. 2011 May;13(5):361-8. doi: 10.1093/ntr/ntr003. Epub 2011 Feb 24.
Zbikowski SM, Jack LM, McClure JB, Deprey M, Javitz HS, McAfee TA, Catz SL, Richards J, Bush T, Swan GE. Utilization of services in a randomized trial testing phone- and web-based interventions for smoking cessation. Nicotine Tob Res. 2011 May;13(5):319-27. doi: 10.1093/ntr/ntq257. Epub 2011 Jan 31.
McClure JB, Swan GE, Catz SL, Jack L, Javitz H, McAfee T, Deprey M, Richards J, Zbikowski SM. Smoking outcome by psychiatric history after behavioral and varenicline treatment. J Subst Abuse Treat. 2010 Jun;38(4):394-402. doi: 10.1016/j.jsat.2010.03.007. Epub 2010 Apr 2.
McClure JB, Swan GE, Jack L, Catz SL, Zbikowski SM, McAfee TA, Deprey M, Richards J, Javitz H. Mood, side-effects and smoking outcomes among persons with and without probable lifetime depression taking varenicline. J Gen Intern Med. 2009 May;24(5):563-9. doi: 10.1007/s11606-009-0926-8. Epub 2009 Feb 24.
Halperin AC, McAfee TA, Jack LM, Catz SL, McClure JB, Deprey TM, Richards J, Zbikowski SM, Swan GE. Impact of symptoms experienced by varenicline users on tobacco treatment in a real world setting. J Subst Abuse Treat. 2009 Jun;36(4):428-34. doi: 10.1016/j.jsat.2008.09.001. Epub 2008 Nov 11.
Other Identifiers
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SRI-751
Identifier Type: -
Identifier Source: secondary_id
CDR0000455745
Identifier Type: -
Identifier Source: org_study_id