Menominee Stop Tobacco Abuse Renew Tradition Study (START)
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|ClinicalTrials.gov Identifier: NCT01083654|
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : February 1, 2016
Last Update Posted : June 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: Standard Treatment Counseling Behavioral: Culturally-Tailored Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Menominee Smoking Cessation Clinical Trial|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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)
- 7-day Point-prevalence Smoking Abstinence [ Time Frame: 6 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083654
|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|