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Smoking Cessation for American Indians

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Won Choi, PhD, MPH, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01106456
First received: April 16, 2010
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Smoking Cessation
Behavioral: Experimental 1: All Nations Breath of Life program (ANBL)
Behavioral: Experimental 2: Nontailored program (NT)
Other: Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Culturally-Tailored Smoking Cessation for American Indians

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Continuous abstinence from smoking for 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of quit attempts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Utilization of smoking cessation pharmacotherapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of cigarettes smoked [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 448
Study Start Date: September 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1: All Nations Breath of Life program (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: Experimental 1: All Nations Breath of Life program (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.
Other: Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)
Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)
Experimental: Experimental 2: Nontailored program (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).
Behavioral: Experimental 2: 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: Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)
Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106456

Locations
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
Sponsors and Collaborators
Won Choi, PhD, MPH
Investigators
Principal Investigator: Won Choi, PhD University of Kansas
  More Information

No publications provided by University of Kansas

Additional 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 Research Institute
ClinicalTrials.gov Identifier: NCT01106456     History of Changes
Other Study ID Numbers: 11862, R01 CA141618
Study First Received: April 16, 2010
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bupropion
Varenicline
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014