Smoking Cessation for American Indians
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ClinicalTrials.gov Identifier: NCT01106456 |
Recruitment Status
:
Completed
First Posted
: April 19, 2010
Results First Posted
: April 26, 2017
Last Update Posted
: April 26, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation | Behavioral: All Nations Breath of Life (ANBL) Behavioral: Nontailored program (NT) Drug: Pharmacotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 463 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Culturally-Tailored Smoking Cessation for American Indians |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: All Nations Breath of Life (ANBL)
All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored "All Nations Breath of Life" program (ANBL) or Nontailored program (NT).
|
Behavioral: All Nations Breath of Life (ANBL)
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.
Drug: Pharmacotherapy
All participants in the study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT)
Other Name: Pharmacotherapy utilization
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Experimental: Nontailored (NT)
All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored "All Nations Breath of Life" program (ANBL) or Nontailored program (NT).
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Behavioral: Nontailored program (NT)
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.
Other Name: Current best practices (CBP)
Drug: Pharmacotherapy
All participants in the study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT)
Other Name: Pharmacotherapy utilization
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- 7-Day Point Prevalence Abstinence From Smoking for 6 Months [ Time Frame: 6 months ]The primary outcome of the study was salivary cotinine-verified 7-day point prevalence smoking abstinence at 6 months (Have you smoked at least part of a cigarette in the past 7 days?) using responders-only analyses.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106456
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Oklahoma | |
University of Oklahoma College of Public Health | |
Oklahoma City, Oklahoma, United States, 73104 |
Principal Investigator: | Won Choi, PhD | University of Kansas Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Won Choi, PhD, MPH, Associate Professor, Preventive Medicine and Public Health, University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT01106456 History of Changes |
Other Study ID Numbers: |
11862 R01CA141618 ( U.S. NIH Grant/Contract ) |
First Posted: | April 19, 2010 Key Record Dates |
Results First Posted: | April 26, 2017 |
Last Update Posted: | April 26, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
Varenicline Bupropion Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antidepressive Agents, Second-Generation |
Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Agents Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |