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

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. Identifier: NCT00301145
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: smoking cessation intervention Drug: varenicline Other: counseling intervention Other: internet-based intervention Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment of Nicotine Dependence in a Health Care Setting
Study Start Date : October 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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


  • 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


  • 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


  • 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

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 identifier (NCT number): NCT00301145

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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)
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Study Chair: Gary E. Swan, PhD SRI International
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00301145    
Other Study ID Numbers: CDR0000455745
First Posted: March 10, 2006    Key Record Dates
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:
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Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs