Clinical trial · Interventional
Varenicline Tartrate With Telephone-Based Counseling and/or Internet-Based Counseling in Helping Adults Stop Smoking
Treatment of Nicotine Dependence in a Health Care Setting
NCT00301145CI-TRIAL-00013155completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Other | — | UNRESOLVED |
| internet-based intervention | Other | — | UNRESOLVED |
| smoking cessation intervention | Behavioral | — | UNRESOLVED |
| varenicline | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- RESULTNishita 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
- DERIVEDTheodoulou 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
- DERIVEDLivingstone-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
- DERIVEDSwan 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
- DERIVEDCatz 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
- DERIVEDZbikowski 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