Please select the eligibility criteria that correspond to the clinical trial below.
Title: Culturally-Tailored Smoking Cessation for American Indians
Brief 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.


Options:
A: Inclusion Criteria:

* currently homeless
* smoke 5 or more cigarettes per day
* smoked 100 cigarettes in lifetime
* aged 18 years or older

Exclusion Criteria:

* unstable mental illness
* pregnancy
* current history of psychoactive or alcohol dependence or psychotic disorder
* cognitive impairment
B: 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
C: Inclusion Criteria:

* Be receiving care for HIV at one of the participating immunology clinics
* Be 18 years old or older
* Be current (past 7 days) cigarette smoker
* Speak English or Spanish

Exclusion Criteria:

* Are pregnant or nursing
* Have uncontrolled hypertension
* Use other forms of tobacco like cigars or chewing tobacco or are using anything else to help with quitting smoking
* Are allergic to the nicotine patch or have a skin condition like eczema or psoriasis that makes them unable to use the patch
D: Inclusion Criteria:

* Currently Homeless
* Smoked at least 100 cigarettes in lifetime
* AUDIT score of \> or equal to 5, \< or equal to 26
* Aged 18 years or older
* Willing to attend study sessions and follow other study protocol

Exclusion Criteria:

* Use of smoking cessation medications or interventions in last 30 days
* Unstable medical illness that requires immediate medical care
* AUDIT score of \< 5 or \> 26
* Pregnancy or other Nicotine Replacement Therapy (NRT) contraindications
* Current history or in past 6 months of psychotic disorder or major depressive disorders that is not stable on treatment for past 3 months
* Cognitive impairment

Answer: B