Menominee Stop Tobacco Abuse Renew Tradition Study

NCT01083654 | Completed Results

• 1 other identifier: H-2009-0194
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking

Keywords

Smoking; Smoking cessation

Outcome Measures

Primary Outcomes (1)

• 7-day Point-prevalence Smoking Abstinence

  Self-reported abstinence (versus smoking) during the past 7 days at the 6-month follow-up time-point, verified by exhaled breath carbon monoxide (CO) measurement (\< 10 parts per million CO is indicative of no smoking).

  6 months

Study Arms (2)

Standard Treatment Counseling

ACTIVE COMPARATOR

Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

Behavioral: Standard Treatment Counseling

Culturally-Tailored Treatment

EXPERIMENTAL

The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

Behavioral: Culturally-Tailored Treatment

Interventions

Standard Treatment Counseling BEHAVIORAL

Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other words, the counseling in the Standard Treatment will be similar to the kind of evidence-based counseling offered to other smokers regardless of race or ethnicity.

Standard Treatment Counseling

Culturally-Tailored Treatment BEHAVIORAL

The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)

Culturally-Tailored Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• University of Wisconsin, Milwaukee: collaborator
• Menominee Indian Tribe of Wisconsin: collaborator

Study Sites (1)

Menominee Tribal Clinic

Keshena, Wisconsin, 54135-0970, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Results Point of Contact

• Title: Stevens S. Smith, Ph.D.
• Organization: University of Wisconsin School of Medicine and Public Health

sss@ctri.wisc.edu

608-262-7563

Study Officials

• Stevens S. Smith, Ph.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Mark Caskey, B.S., R.N.

  Menominee Tribal Clinic

  STUDY DIRECTOR

• Leah Arndt, Ph.D.

  University of Wisconsin, Milwaukee

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 17, 2016
• Results First Posted: February 1, 2016

Record last verified: 2016-05

Locations

US (1)