Clinical trial · Interventional
Improving Varenicline Adherence and Outcomes in Homeless Smokers
NCT00786149CI-TRIAL-00015532completedPhase 3ClinicalTrials.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)
the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit 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 |
|---|---|---|---|
| Tobacco Use Cessation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Varenicline plus Motivational Interviewing counseling | Other | — | UNRESOLVED |
| Varenicline without counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Participants will receive NRT and Motivational Interviewing counseling
- interventionNames
- Other: Varenicline plus Motivational Interviewing counseling
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Varenicline plus brief advice
- interventionNames
- Other: Varenicline without counseling
Primary outcomes (1)
- measure
- 7-day point prevalence abstinence from smoking
- timeFrame
- 6 months after enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * currently homeless * smoke 5 or more cigarettes per day * smoked 100 cigarettes in lifetime * aged 18 years or older Exclusion Criteria: * unstable mental illness * pregnancy * current history of psychoactive or alcohol dependence or psychotic disorder * cognitive impairment
References
Publications (4)
- 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
- DERIVEDOjo-Fati O, Joseph AM, Ig-Izevbekhai J, Thomas JL, Everson-Rose SA, Pratt R, Raymond N, Cooney NL, Luo X, Okuyemi KS. Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned. Trials. 2017 Jul 5;18(1):305. doi: 10.1186/s13063-017-2046-9. PMID 28679430
- DERIVEDOjo-Fati O, Thomas JL, Vogel RI, Ogedegbe O, Jean-Louis G, Okuyemi KS. Predictors of Adherence to Nicotine Replacement Therapy (Nicotine Patch) Among Homeless Persons Enrolled in a Randomized Controlled Trial Targeting Smoking Cessation. J Fam Med. 2016;3(7):1079. Epub 2016 Sep 6. PMID 28580456
- DERIVEDGoldade K, Whembolua GL, Thomas J, Eischen S, Guo H, Connett J, Des Jarlais D, Resnicow K, Gelberg L, Owen G, Grant J, Ahluwalia JS, Okuyemi KS. Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial. Clin Trials. 2011 Dec;8(6):744-54. doi: 10.1177/1740774511423947. PMID 22167112