Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Prevention	Closed	18 and over	NCI	SRI-751 NCT00301145

Objectives

1. Determine the effectiveness of varenicline with telephone counseling vs Internet-based counseling vs telephone counseling and Internet-based smoking cessation interventions in adult smokers.
2. Determine individual or group differences in patients undergoing these interventions.
3. Determine heterogeneity in responsiveness in regard to the Classification and Regression Tree Analysis in patients undergoing these interventions.
4. 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.
5. Determine the cost-effectiveness of these interventions.

Entry 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

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

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

Expected Enrollment

A total of 1,200 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

SRI International

Gary Swan, PhD, Protocol chair		Ph: 650-859-5322 Email: gary.swan@sri.com

Registry Information
Official Title		Treatment of Nicotine Dependence in a Health Care Setting
Trial Start Date		2005-10-05
Trial Completion Date		2008-06-06 (estimated)
Registered in ClinicalTrials.gov		NCT00301145
Date Submitted to PDQ		2005-10-04
Information Last Verified		2007-09-30
NCI Grant/Contract Number		CA71358

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