Menominee Stop Tobacco Abuse Renew Tradition Study (START)

University of Wisconsin (UW)

Status: Completed

Conditions: Smoking

Treatments: Behavioral: Culturally-Tailored Treatment; Behavioral: Standard Treatment Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01083654

H-2009-0194

Details and patient eligibility

About

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).

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Standard Treatment Counseling

Active Comparator group

Description:

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).

Treatment:

Behavioral: Standard Treatment Counseling

Culturally-Tailored Treatment

Experimental group

Description:

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).

Treatment:

Behavioral: Culturally-Tailored Treatment