N/A
Completed N=103
Menominee Stop Tobacco Abuse Renew Tradition Study
Source: ClinicalTrials.gov NCT01083654 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: 7-day Point-prevalence Smoking Abstinence — 12; 7 Number of abstinent participants — p=.262
Summary
The purpose of this community-based study is to evaluate the effectiveness of a culturally-tailored smoking cessation treatment for American Indian (AI) smokers as compared to standard evidence-based cessation treatment (not culturally-tailored).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point-prevalence Smoking Abstinence |
12; 7 | .262 |
Eligibility Criteria
Inclusion Criteria
- at least 18 years of age
- must smoke cigarettes
- eligible to receive health care services at the Menominee Tribal Clinic (i.e., must be an enrolled member of a federally-recognized American Indian Tribe)
- primary care provider (M.D. or Nurse Practitioner) is at the Menominee Tribal Clinic
- must be medically able and willing to take varenicline
Exclusion Criteria
- end-stage renal disease with hemodialysis
- any prior suicide attempts
- current or recent (past 12 months) suicidal ideation
- currently pregnant or breastfeeding
- unwilling to use appropriate methods of birth control while taking study medication and for 1 month after discontinuing study medication
- primary care provider (PCP) determines that the individual should not take varenicline
Data sourced from ClinicalTrials.gov (NCT01083654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.