Smoking Cessation Clinical Trial
Official title:
Culturally-Tailored Smoking Cessation for American Indians
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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