Menominee Stop Tobacco Abuse Renew Tradition Study
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
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.
তারিখ
| সর্বশেষ যাচাই করা হয়েছে: | 04/30/2016 |
| প্রথম জমা দেওয়া: | 03/07/2010 |
| আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 03/07/2010 |
| প্রথম পোস্ট: | 03/09/2010 |
| সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 05/15/2016 |
| সর্বশেষ আপডেট পোস্ট: | 06/16/2016 |
| প্রথম জমা দেওয়া ফলাফলের তারিখ: | 12/28/2015 |
| প্রথম জমা দেওয়া কিউসির ফলাফলের তারিখ: | 12/28/2015 |
| প্রথম পোস্ট ফলাফলের তারিখ: | 01/31/2016 |
| আসল অধ্যয়ন শুরুর তারিখ: | 01/31/2010 |
| আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 10/31/2011 |
| আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 10/31/2011 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Behavioral: Standard Treatment Counseling
Behavioral: Culturally-Tailored Treatment
পর্যায়
বাহু গ্রুপ
| বাহু | হস্তক্ষেপ / চিকিত্সা |
|---|---|
| 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) |
যোগ্যতার মানদণ্ড
| বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
| লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
| স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
| নির্ণায়ক | 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 |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. 7-day Point-prevalence Smoking Abstinence [6 months]
