Smoking Cessation for American Indians
Condition: Smoking Cessation
Intervention: All Nations Breath of Life (ANBL); Nontailored program (NT); Pharmacotherapy
Intervention description: ANBL consists of in-person group sessions and individual telephone calls. We have successfully conducted a pilot study of ANBL and have found very promising results. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.; The nontailored intervention includes the medicines listed above to all participants and targeted counseling delivered by non-American Indian counselors who have worked closely with the American Indian communities and respect the cultures, values, and traditions of the Indian people. Therefore, our intervention includes the current "best practice" recommendations for smoking cessation. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.; All participants in the study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      American Indians and Alaska Natives (AI/ANs) have the highest smoking rates of the major
      racial/ethnic groups in the United States, approaching 40% to 50%.1-3 In addition, this
      underserved population has very low smoking cessation and abstinence rates. The
      smoking-attributable mortality rate of AI/ANs is not only the highest but double that of
      other ethnic groups.4 To date, there have been almost no studies that have focused on methods
      to encourage smoking cessation among AI/AN smokers and no randomized clinical trials. There
      is a desperate need for effective, culturally tailored cessation programs.5, 6 We propose a 2
      arm, group randomized clinical trial to be conducted at 2 sites in the Midwest (Kansas and
      Oklahoma).

      We have begun to address these issues through the creation of the "All Nations Breath of
      Life" (ANBL) smoking cessation program using community-based participatory research methods.
      ANBL is group-based and is culturally-sensitive in all program components. It recognizes the
      sacred role of tobacco among many AI/ANs and how culture affects smoking cessation among
      AI/AN, while still addressing recreational smoking. Our pilot work shows promise for reducing
      cigarette smoking in AI/AN smokers, with quit rates of 30% at six months post-baseline,
      compared to 8-10% quit rates in other published studies.

      All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline or
      Bupropion or NRT) then randomized into either the culturally-tailored "All Nations Breath of
      Life" program (ANBL) or Nontailored (NT. ANBL consists of in-person group sessions and
      individual telephone calls. We have successfully conducted a pilot study of ANBL and have
      found very promising results. At 6 months post baseline, all participants will be assessed
      for smoking status and continuous abstinence. We will randomize 28 groups per site (8 smokers
      per group) to ANBL or NT for a total sample size of 448 AI/AN smokers.

      This study is the first controlled trial to examine the efficacy of a culturally-tailored
      smoking cessation program for AI/ANs. In collaboration with AI/AN colleagues in Oklahoma we
      designed and successfully piloted the intervention to be culturally-tailored and sustainable
      in order to enhance its potential for widespread adoption and ultimate impact among AI/AN
      smokers. If the intervention is successful, the potential health impact is significant
      because the prevalence of smoking is the highest in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Have a home address and telephone number

          -  Willing to participate in all study components

          -  Willing to be followed for 6 months

          -  Smoked at least 100 cigarettes in their lifetime

          -  Current smoker

          -  American Indian or Alaska Native

        Exclusion Criteria:

          -  Planning to leave the state within next 24 months

          -  Pregnant or breast feeding or planning to become pregnant in next 4 months.

          -  Medically ineligible after screening