Clinical trial · Interventional
Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
NCT02596711CI-TRIAL-00043906completedPhase 1 / Phase 2Results postedClinicalTrials.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 goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Prevention | — | UNRESOLVED | — |
| Tobacco Use Cessation | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon Monoxide (CO) Test | Other | — | UNRESOLVED |
| Counseling Sessions | Behavioral | — | UNRESOLVED |
| Culturally Tailored Reading Materials | Behavioral | — | UNRESOLVED |
| Health Education and Handouts | Behavioral | — | UNRESOLVED |
| Nicotine Patch | Drug | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Health Education (HE) Group
- description
- Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
- interventionNames
- Drug: Nicotine Patch
- Behavioral: Questionnaires
- Other: Carbon Monoxide (CO) Test
- Behavioral: Health Education and Handouts
- Behavioral: Counseling Sessions
- type
- EXPERIMENTAL
- label
- Culturally Tailored Smoking Cessation (CTSC) Group
- description
- Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults at least 18 years of age 2. Current smoker (\>5 cigarettes per day for the past 3 months) 3. Able to speak and read English or Spanish 4. Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up 5. Willing to set a quit date within 2 weeks of enrollment date 6. Identify as being of Latino heritage, ethnicity, or ancestry Exclusion Criteria: 1. Individuals suffering from any unstable medical condition precluding the use of NRT (Identified using the Medical History Questionnaire given at baseline) 2. Currently using smokeless tobacco, electronic nicotine delivery systems (ENDS), nicotine replacement therapy, or other smoking cessation treatment 3. Pregnant or nursing 4. Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation 5. Diagnosis of substance dependence other than nicotine (screened using DSM IV TR criteria) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition 6. Individuals that do not have access to a working telephone
References
Publications (1)
- DERIVEDde Dios MA, Cano MA, Vaughan EL, Childress SD, McNeel MM, Harvey LM, Niaura RS. A pilot randomized trial examining the feasibility and acceptability of a culturally tailored and adherence-enhancing intervention for Latino smokers in the U.S. PLoS One. 2019 Jan 11;14(1):e0210323. doi: 10.1371/journal.pone.0210323. eCollection 2019. PMID 30633744