Varenicline Tartrate With Telephone-Based Counseling and/or Internet-Based Counseling in Helping Adults Stop Smoking
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Behavioral: smoking cessation intervention Drug: varenicline Other: counseling intervention Other: internet-based intervention|
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Treatment of Nicotine Dependence in a Health Care Setting|
|Study Start Date:||October 2005|
|Study Completion Date:||November 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301145
|United States, California|
|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|
|Study Chair:||Gary E. Swan, PhD||SRI International|