Trial Outcomes & Findings for Smoking Cessation for American Indians (NCT NCT01106456)

Last Updated: 2017-04-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

463 participants

Primary outcome timeframe

6 months

Results posted on

2017-04-26

Participant Flow

Participants were recruited from Southern and Northern Plains regions, from reservations communities and in rural locations, including tribal trust land.

Exclusion criteria included intention to leave the state within the next 2 years, being pregnant/breastfeeding, planning to become pregnant in next 4 months, being medically ineligible after screening. Participants were recruited in April 2011, the final participant had their 6-month follow-up in July 2014.

Participant milestones

Participant milestones
Measure	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 the culturally-tailored "All Nations Breath of Life" program (ANBL)	Nontailored Program (NT) All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
Overall Study STARTED	243	220
Overall Study COMPLETED	140	96
Overall Study NOT COMPLETED	103	124

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The row populations only includes participants with available data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Nations Breath of Life Program (ANBL) n=243 Participants All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored "All Nations Breath of Life" program (ANBL)	Nontailored Program (NT) n=220 Participants All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).	Total n=463 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=226 Participants • The row populations only includes participants with available data.	0 Participants n=215 Participants • The row populations only includes participants with available data.	0 Participants n=441 Participants • The row populations only includes participants with available data.
Age, Categorical Between 18 and 65 years	212 Participants n=226 Participants • The row populations only includes participants with available data.	206 Participants n=215 Participants • The row populations only includes participants with available data.	418 Participants n=441 Participants • The row populations only includes participants with available data.
Age, Categorical >=65 years	14 Participants n=226 Participants • The row populations only includes participants with available data.	9 Participants n=215 Participants • The row populations only includes participants with available data.	23 Participants n=441 Participants • The row populations only includes participants with available data.
Age, Continuous	45.43 years STANDARD_DEVIATION 12.98 • n=226 Participants • The row populations only includes participants with available data.	43.12 years STANDARD_DEVIATION 13.22 • n=215 Participants • The row populations only includes participants with available data.	44.3 years STANDARD_DEVIATION 13.13 • n=441 Participants • The row populations only includes participants with available data.
Sex: Female, Male Female	167 Participants n=230 Participants • The row populations only includes participants with available data.	168 Participants n=217 Participants • The row populations only includes participants with available data.	335 Participants n=447 Participants • The row populations only includes participants with available data.
Sex: Female, Male Male	63 Participants n=230 Participants • The row populations only includes participants with available data.	49 Participants n=217 Participants • The row populations only includes participants with available data.	112 Participants n=447 Participants • The row populations only includes participants with available data.

PRIMARY outcome

Timeframe: 6 months

Population: The difference in the "overall number of participants analyzed, "from the "number analyzed," in the ANBL arm, is due to missing data.

Outcome measures

Outcome measures
Measure	All Nations Breath of Life Program (ANBL) n=140 Participants All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored "All Nations Breath of Life" program (ANBL).	Nontailored Program (NT) n=96 Participants All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
7-Day Point Prevalence Abstinence From Smoking for 6 Months Self-reported Responder Only	49 Participants	26 Participants
7-Day Point Prevalence Abstinence From Smoking for 6 Months Cotinine verified Responder only	26 Participants	15 Participants

Adverse Events

Experimental 1: All Nations Breath of Life Program (ANBL)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Experimental 2: Nontailored Program (NT)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental 1: All Nations Breath of Life Program (ANBL) n=243 participants at risk 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). 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. Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)	Experimental 2: Nontailored Program (NT) n=220 participants at risk 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). 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. Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)
General disorders Sleep disturbance	0.41% 1/243 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.91% 2/220 • Number of events 2 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Depression	0.82% 2/243 • Number of events 2 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.91% 2/220 • Number of events 2 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Upset stomach	0.41% 1/243 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.00% 0/220 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Nausea	0.00% 0/243 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.45% 1/220 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Elevated blood pressure	0.00% 0/243 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.45% 1/220 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Constipation	0.41% 1/243 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.00% 0/220 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Aggressiveness and irritability	0.41% 1/243 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.00% 0/220 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Skin reactions	0.41% 1/243 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.00% 0/220 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Chest pain	0.00% 0/243 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.45% 1/220 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.
General disorders Chest pressure	0.00% 0/243 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.	0.45% 1/220 • Number of events 1 • Adverse event data was collected throughout the duration of the study (5 years). All-cause mortality cases were unrelated to the study medication of intervention components.

Additional Information

Dr. Won S. Choi

The University of Kansas Medical Center

Phone: (913) 588-4742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place