Menominee Stop Tobacco Abuse Renew Tradition Study

Smoking is the leading preventable cause of illness and death. American Indians (AIs) have
the highest rate of smoking but very little research has addressed how to help AIs quit
smoking. AIs also suffer health disparities related to the addictive use of commercial
tobacco. Many AIs also use natural tobacco for ceremonial purposes in addition to using
commercial tobacco in an addictive manner. This study will add important new knowledge about
how best to help AI smokers quit smoking (addictive use of commercial tobacco) and this is
expected to help reduce the prevalence of smoking and smoking-related illness in AI
communities. The "Menominee Smoking Cessation Clinical Trial" is a community-based study
designed to evaluate a culturally-appropriate, evidence-based smoking cessation intervention
for AI smokers. This project joins together collaborators at the University of Wisconsin
Center for Tobacco Research and Intervention (UW-CTRI; PI Dr. Stevens Smith; smoking
cessation expertise), the UW Carbone Comprehensive Cancer Center (UWCCC), the University of
Wisconsin-Milwaukee (UWM; Dr. Leah Arndt; qualitative analysis expertise), and the Menominee
Tribal Clinic (MTC; Wellness Director Mr. Mark Caskey; MTC Director Mr. Jerry Waukau, an
enrolled member of the Menominee Tribe; and Ms. Jodi Fossum, an enrolled member of the
Menominee Tribe) that serves Menominee and other AI patients. The study will randomize 150
AI smokers to two treatment conditions: (1) a standard evidence-based smoking cessation
treatment condition (FDA-approved varenicline for 12 weeks + 4 counseling sessions), and,
(2) a culturally-tailored smoking cessation treatment condition consisting of the standard
treatment (FDA-approved varenicline for 12 weeks + 4 counseling sessions) plus
culturally-appropriate treatment elements. Follow-up will be conducted at 3 and 6 months
post-quit to assess smoking status and other study outcomes. We also plan to collect and
analyze qualitative data (this aspect of the study will be led by Dr. Arndt) to learn more
about the process and factors associated with cessation of commercial tobacco in American
Indians including cultural factors.

Inclusion Criteria:

1. at least 18 years of age

2. must smoke cigarettes

3. 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)

4. primary care provider (M.D. or Nurse Practitioner) is at the Menominee Tribal Clinic

5. must be medically able and willing to take varenicline

Exclusion Criteria:

1. end-stage renal disease with hemodialysis

2. any prior suicide attempts

3. current or recent (past 12 months) suicidal ideation

4. currently pregnant or breastfeeding

5. unwilling to use appropriate methods of birth control while taking study medication
and for 1 month after discontinuing study medication

6. primary care provider (PCP) determines that the individual should not take
varenicline