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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SRI International
• Collaborator: National Cancer Institute (NCI)
• Treatments: Varenicline

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