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

Stanford Research Institute (SRI) International

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Behavioral: smoking cessation intervention; Drug: varenicline; Other: counseling intervention; Other: internet-based intervention

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00301145

CDR0000455745

SRI-751

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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