Smoking CessationPhase 3NCT01106456
Smoking Cessation for American Indians
A Phase 3 study testing All Nations Breath of Life (ANBL), Nontailored program (NT) and Pharmacotherapy in people with Smoking Cessation, run by Won Choi, PhD, MPH at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- All Nations Breath of Life (ANBL), Nontailored program (NT) and Pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Oklahoma College of Public Health
Oklahoma City, Oklahoma, 73104
About this study
Official title: Culturally-Tailored Smoking Cessation for American Indians
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.
Read more
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- All Nations Breath of Life (ANBL), Nontailored program (NT), Pharmacotherapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All Nations Breath of Life (ANBL)Behavioural
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.
Nontailored program (NT)Behavioural
Also called Current best practices (CBP)
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.
PharmacotherapyDrug
Also called Pharmacotherapy utilization
All participants in the study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Nontailored program (NT); Drug: Pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Won Choi, PhD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Won Choi, PhD, MPH, University of Kansas Medical Center
- Investigators
- Won Choi, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106456
- Sponsor's protocol ID
- 11862
- Other IDs
- R01CA141618
- Status last verified
- Mar 2017
- First submitted
- 16 Apr 2010
- Last updated
- 26 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21592347
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-Tailored Smoking Cessation for American Indians
- ClinicalTrials.gov ID
- NCT01106456
- Acronym / sponsor ID
- 11862
- Conditions
- Smoking Cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Won Choi, PhD, MPHUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Posted 26 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All Nations Breath of Life (ANBL) | Experimental | Behavioral: All Nations Breath of Life (ANBL), Drug: PharmacotherapyAll 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). |
| Nontailored (NT) | Experimental | Behavioral: Nontailored program (NT), Drug: PharmacotherapyAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | All Nations Breath of Life (ANBL) |
| Nontailored program (NT)Also: Current best practices (CBP)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. | Behavioural | Nontailored (NT) |
| PharmacotherapyAlso: Pharmacotherapy utilizationAll participants in the study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) | Drug | All Nations Breath of Life (ANBL), Nontailored (NT) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21592347Choi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Choi, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing All Nations Breath of Life (ANBL), Nontailored program (NT) and Pharmacotherapy in people with Smoking Cessation, run by Won Choi, PhD, MPH at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point Prevalence Abstinence From Smoking for 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01106456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.