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Smoking Cessation for American Indians

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106456
First Posted: April 19, 2010
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Won Choi, PhD, MPH, University of Kansas Medical Center
  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: All Nations Breath of Life (ANBL) Behavioral: Nontailored program (NT) Drug: Pharmacotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Won Choi, PhD, MPH, University of Kansas Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 463
Study Start Date: September 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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).
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

Detailed Description:
This study will use a group randomized multi-site clinical trial design to examine the efficacy of a culturally-tailored smoking cessation program (ANBL) for AI/AN smokers versus Non-tailored (NT). AI/AN smokers in two sites (Kansas and Oklahoma) will be group randomized to either ANBL or Non-tailored (NT). Each site (KS and OK) will randomize 28 groups, resulting in 14 groups per arm of the intervention, per site. Participants in both groups (ANBL and NT) will be offered pharmacotherapy (e.g. varenicline or bupropion or NRT). The primary outcome of interest will be biochemically verified continuous abstinence at 1 year. Secondary endpoints include number of quit attempts and number of cigarettes smoked (among continuing smokers), pharmacotherapy utilization, and the number of completed group sessions. We will also examine the marginal cost-effectiveness of the intervention. The study will proceed in three phases over a five-year period. Phase I will consist of development and training. Phase 2 will be to conduct the randomized trial, and Phase 3 consists of data analysis and dissemination. Participants will be recruited from two sites: Kansas and Oklahoma. Although the ANBL arm is a group intervention and the NT arm is individual standard care, the unit of randomization will be at the group level (further discussed in the next section - Randomization process). Recruitment and randomization will be balanced by site: both sites will recruit until we reach our target sample size of 448 AI/AN smokers who are at least 18 years of age. Each site will randomize 28 groups (14 groups per arm) with 8 smokers in each group for a total site sample size of 224 smokers per site. Pharmacotherapy: The PI and site PI of this study along with our AI/AN community members agreed that all participants (ANBL and NT arms) had to be offered pharmacotherapy (varenicline or bupropion or NRT) as a component of the study design. This decision was a collaborative one between the AI/AN tribes and the investigators who have worked with this population. The AI/AN community will not accept placebo treatment, therefore, the interventions would not be acceptable or feasible to potential participants if a placebo was part of the study design. In addition, we believed it was ethically imperative that we provided smoking cessation interventions consistent with the current clinical practice guidelines for the treatment of tobacco use.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Won Choi, PhD University of Kansas Medical Center
  More Information

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 Submitted: April 16, 2010
First Posted: April 19, 2010
Results First Submitted: March 14, 2017
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