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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.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 8, 2006
Last updated: December 18, 2013
Last verified: September 2007

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: 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:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00301145

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)
Study Chair: Gary E. Swan, PhD SRI International
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00301145     History of Changes
Other Study ID Numbers: CDR0000455745
Study First Received: March 8, 2006
Last Updated: December 18, 2013

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

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on July 26, 2017