Clinical trial NCT01083654: Menominee Stop Tobacco Abuse Renew Tradition Study
Official title: Menominee Smoking Cessation Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Smoking cessation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Milwaukee
name: Menominee Indian Tribe of Wisconsin
First posted: 2010-03-10
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 7-day Point-prevalence Smoking Abstinence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Keshena
country: United States
facility: Menominee Tribal Clinic
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stevens S. Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Menominee Tribal Clinic
name: Mark Caskey, B.S., R.N.
role: STUDY_DIRECTOR
affiliation: University of Wisconsin, Milwaukee
name: Leah Arndt, Ph.D.
role: STUDY_CHAIR
References: