Status:
COMPLETED
Varenicline Tartrate With Telephone-Based Counseling and/or Internet-Based Counseling in Helping Adults Stop Smoking
Lead Sponsor:
SRI International
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
NA
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 sto...
Detailed 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 smo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00301145
Start Date
October 1 2005
End Date
November 1 2008
Last Update
December 19 2013
Active Locations (3)
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1
SRI International
Menlo Park, California, United States, 94025
2
Center for Health Studies
Seattle, Washington, United States, 98101-1448
3
Free & Clear, Incorporated
Seattle, Washington, United States, 98104