Smoking Cessation for American Indians

Smoking Cessation Clinical Trial

Official title:

Culturally-Tailored Smoking Cessation for American Indians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106456
• Other study ID #: 11862
• Secondary ID: R01CA141618
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2010
• Last updated: June 3, 2015
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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)

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Oklahoma College of Public Health	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Won Choi, PhD, MPH	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-Day point prevalence abstinence from smoking for 6 months	Will perform for both per protocol and intent-to-treat for self-reported and salivary cotinine verified	6 months	No
Secondary	Number of cigarettes smoked		6 months	No
Secondary	Utilization of smoking cessation pharmacotherapy		6 months	No
Secondary	Number of quit attempts		6 months	No