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

NCT00301145 | Completed

• 2 other identifiers: CDR0000455745SRI-751
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

smoking cessation intervention BEHAVIORAL

varenicline DRUG

counseling intervention OTHER

internet-based intervention OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SRI International: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

SRI International

Menlo Park, California, 94025, United States

Location

Center for Health Studies

Seattle, Washington, 98101-1448, United States

Location

Free & Clear, Incorporated

Seattle, Washington, 98104, United States

Location

Related Publications (9)

• 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. doi: 10.1186/1471-2288-9-71.

  PMID: 19874586 RESULT

• Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

  PMID: 39868569 DERIVED

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

• Swan GE, Javitz HS, Jack LM, Wessel J, Michel M, Hinds DA, Stokowksi RP, McClure JB, Catz SL, Richards J, Zbikowski SM, Deprey M, McAfee T, Conti DV, Bergen AW. Varenicline for smoking cessation: nausea severity and variation in nicotinic receptor genes. Pharmacogenomics J. 2012 Aug;12(4):349-58. doi: 10.1038/tpj.2011.19. Epub 2011 May 24.

  PMID: 21606948 DERIVED

• 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. doi: 10.1093/ntr/ntr003. Epub 2011 Feb 24.

  PMID: 21350041 DERIVED

• 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. doi: 10.1093/ntr/ntq257. Epub 2011 Jan 31.

  PMID: 21330267 DERIVED

• 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. doi: 10.1016/j.jsat.2010.03.007. Epub 2010 Apr 2.

  PMID: 20363092 DERIVED

• 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. doi: 10.1007/s11606-009-0926-8. Epub 2009 Feb 24.

  PMID: 19238488 DERIVED

• 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. doi: 10.1016/j.jsat.2008.09.001. Epub 2008 Nov 11.

  PMID: 19004600 DERIVED

MeSH Terms

Interventions

Varenicline; Counseling

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gary E. Swan, PhD

  SRI International

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 10, 2006
• Study Start: October 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 19, 2013

Record last verified: 2007-09

Locations

US (3)