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

Sponsor:	SRI International
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00301145

Purpose

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.

Condition	Intervention
Unspecified Adult Solid Tumor, Protocol Specific	Behavioral: smoking cessation intervention Drug: varenicline Other: counseling intervention Other: internet-based intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Prevention
Official Title:	Treatment of Nicotine Dependence in a Health Care Setting

Resource links provided by NLM:

MedlinePlus related topics: Cancer Quitting Smoking Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	1200
Study Start Date:	October 2005
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301145

Locations

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

Sponsors and Collaborators

SRI International

National Cancer Institute (NCI)

Investigators

Study Chair:

Gary E. Swan, PhD

SRI International

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Nishita DM, Jack LM, McElroy M, McClure JB, Richards J, Swan GE, Bergen AW. Clinical trial participant characteristics and saliva and DNA metrics. BMC Med Res Methodol. 2009 Oct 29;9:71.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Catz SL, Jack LM, McClure JB, Javitz HS, Deprey M, Zbikowski SM, McAfee T, Richards J, Swan GE. Adherence to varenicline in the COMPASS smoking cessation intervention trial. Nicotine Tob Res. 2011 May;13(5):361-8. Epub 2011 Feb 24.

Zbikowski SM, Jack LM, McClure JB, Deprey M, Javitz HS, McAfee TA, Catz SL, Richards J, Bush T, Swan GE. Utilization of services in a randomized trial testing phone- and web-based interventions for smoking cessation. Nicotine Tob Res. 2011 May;13(5):319-27. Epub 2011 Jan 31.

McClure JB, Swan GE, Catz SL, Jack L, Javitz H, McAfee T, Deprey M, Richards J, Zbikowski SM. Smoking outcome by psychiatric history after behavioral and varenicline treatment. J Subst Abuse Treat. 2010 Jun;38(4):394-402. Epub 2010 Apr 2.

McClure JB, Swan GE, Jack L, Catz SL, Zbikowski SM, McAfee TA, Deprey M, Richards J, Javitz H. Mood, side-effects and smoking outcomes among persons with and without probable lifetime depression taking varenicline. J Gen Intern Med. 2009 May;24(5):563-9. Epub 2009 Feb 24.

Halperin AC, McAfee TA, Jack LM, Catz SL, McClure JB, Deprey TM, Richards J, Zbikowski SM, Swan GE. Impact of symptoms experienced by varenicline users on tobacco treatment in a real world setting. J Subst Abuse Treat. 2009 Jun;36(4):428-34. Epub 2008 Nov 11.

ClinicalTrials.gov Identifier:	NCT00301145 History of Changes
Other Study ID Numbers:	CDR0000455745, SRI-751
Study First Received:	March 8, 2006
Last Updated:	March 13, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists

Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012