Menominee Stop Tobacco Abuse Renew Tradition Study (START)
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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 |
- 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).
- 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 |
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
Contacts and Locations| United States, Wisconsin | |
| Menominee Tribal Clinic | |
| Keshena, Wisconsin, United States, 54135-0970 | |
| 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 |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on June 18, 2013