Smoking Cessation for American Indians

NCT01106456 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 11862R01CA141618
• Study Type: interventional
• Target: 463
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 7-Day Point Prevalence Abstinence From Smoking for 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.

  6 months

Study Arms (2)

All Nations Breath of Life (ANBL)

EXPERIMENTAL

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); Drug: Pharmacotherapy

Nontailored (NT)

EXPERIMENTAL

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); Drug: Pharmacotherapy

Interventions

All Nations Breath of Life (ANBL) BEHAVIORAL

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.

All Nations Breath of Life (ANBL)

Nontailored program (NT) BEHAVIORAL

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.

Also known as: Current best practices (CBP)

Nontailored (NT)

Pharmacotherapy DRUG

All participants in the study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT)

Also known as: Pharmacotherapy utilization

All Nations Breath of Life (ANBL); Nontailored (NT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Won Choi, PhD, MPH: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Oklahoma College of Public Health

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Choi WS, Faseru B, Beebe LA, Greiner AK, Yeh HW, Shireman TI, Talawyma M, Cully L, Kaur B, Daley CM. Culturally-tailored smoking cessation for American Indians: study protocol for a randomized controlled trial. Trials. 2011 May 18;12:126. doi: 10.1186/1745-6215-12-126.

  PMID: 21592347 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Significant loss to follow-up, lower than expected salivary collection rates, lower long-term retention of participants, and higher than expected drop off from randomization to enrollment.

Results Point of Contact

• Title: Dr. Won S. Choi
• Organization: The University of Kansas Medical Center

wchoi@kumc.edu

(913) 588-4742

Study Officials

• Won Choi, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Preventive Medicine and Public Health

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 19, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 26, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)