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Varenicline Tartrate With Telephone-Based Counseling and/or Internet-Based Counseling in Helping Adults Stop Smoking

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00301145
First Posted: March 10, 2006
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Varenicline tartrate may help people quit smoking by decreasing the symptoms of nicotine withdrawal. It is not yet known whether varenicline tartrate is more effective in helping people stop smoking when given together with a telephone-based counseling program, and Internet-based counseling program, or both programs.

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: smoking cessation intervention Drug: varenicline Other: counseling intervention Other: internet-based intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment of Nicotine Dependence in a Health Care Setting

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1200
Study Start Date: October 2005
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Smokes 10 or more cigarettes/day over the past year AND ≥ 5 cigarettes/day within the past week
  • Planning to stop smoking in 4-6 weeks
  • Member of Group Health Cooperative (GHC) and planning to stay enrolled for the next 6 months
  • Eligible for the Free & Clear program
  • Enrolled in the COMPASS study using bupropion hydrochloride medication
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301145


Locations
United States, California
SRI International
Menlo Park, California, United States, 94025
United States, Washington
Center for Health Studies
Seattle, Washington, United States, 98101-1448
Free & Clear, Incorporated
Seattle, Washington, United States, 98104
Sponsors and Collaborators
SRI International
National Cancer Institute (NCI)
Investigators
Study Chair: Gary E. Swan, PhD SRI International
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. Erratum in: J Gen Intern Med. 2009 Oct;24(10):1173.
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.

ClinicalTrials.gov Identifier: NCT00301145     History of Changes
Other Study ID Numbers: CDR0000455745
SRI-751
First Submitted: March 8, 2006
First Posted: March 10, 2006
Last Update Posted: December 19, 2013
Last Verified: September 2007

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


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