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Treatment of Nicotine Dependence in a Health Care Setting

18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Treatment of Nicotine Dependence in a Health Care Setting


- 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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Prevention

Principal Investigator

Gary E. Swan, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

SRI International


United States: Federal Government

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Tobacco Use Disorder



SRI International Menlo Park, California  94025
Center for Health Studies Seattle, Washington  98101-1448
Free & Clear, Incorporated Seattle, Washington  98104