Menominee Stop Tobacco Abuse Renew Tradition Study (START)

This study has been completed.
Sponsor:
Collaborators:
University of Wisconsin, Milwaukee
Menominee Indian Tribe of Wisconsin
Information provided by (Responsible Party):
Stevens Smith, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01083654
First received: March 8, 2010
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention
Smoking
Behavioral: Standard Treatment Counseling
Behavioral: Culturally-Tailored Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Menominee Smoking Cessation Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 7-day point-prevalence smoking abstinence [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Self-reported abstinence (versus smoking) during the past 7 days at the 3- and 6-month follow-up time-points, verified by exhaled breath carbon monoxide (CO) measurement (< 10 parts per million CO is indicative of no smoking).


Secondary Outcome Measures:
  • Qualitative analysis [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Qualitative interviews will be conducted at baseline and at the 6-month follow-up to assess tobacco- and cessation-related beliefs and experiences of study participants. Dr. Leah Arndt will lead the analysis of transcripts of the qualitative interviews.


Enrollment: 108
Study Start Date: February 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Treatment Counseling
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
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.
Experimental: Culturally-Tailored Treatment
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
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083654

Locations
United States, Wisconsin
Menominee Tribal Clinic
Keshena, Wisconsin, United States, 54135-0970
Sponsors and Collaborators
University of Wisconsin, Madison
University of Wisconsin, Milwaukee
Menominee Indian Tribe of Wisconsin
Investigators
Principal Investigator: Stevens S. Smith, Ph.D. University of Wisconsin, Madison
Study Director: Mark Caskey, B.S., R.N. Menominee Tribal Clinic
Study Chair: Leah Arndt, Ph.D. University of Wisconsin, Milwaukee
  More Information

No publications provided

Responsible Party: Stevens Smith, Associate Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01083654     History of Changes
Other Study ID Numbers: H-2009-0194
Study First Received: March 8, 2010
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Smoking
Smoking cessation

ClinicalTrials.gov processed this record on October 19, 2014