Trial Outcomes & Findings for Tobacco Dependence Treatment for Asian Americans (NCT NCT01091363)

NCT ID: NCT01091363

Last Updated: 2019-03-13

Results Overview

The number of participants who had maintained smoking abstinence for the past 12 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 109 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-03-13

Participant Flow

2010-2013.

232 people were screened and 123 were excluded before randomization.

Participant milestones

Measure	Deep Cultural This arm received eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT nicotine patch: 8-week nicotine patch therapy	Standard This arm received eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture. nicotine patch: 8-week nicotine patch therapy
Overall Study STARTED	55	54
Overall Study COMPLETED	42	37
Overall Study NOT COMPLETED	13	17

Reasons for withdrawal

Measure	Deep Cultural This arm received eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT nicotine patch: 8-week nicotine patch therapy	Standard This arm received eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture. nicotine patch: 8-week nicotine patch therapy
Overall Study Withdrawal by Subject	11	15
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Tobacco Dependence Treatment for Asian Americans

Baseline characteristics by cohort

Measure	Deep Cultural n=55 Participants eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT nicotine patch: 8-week nicotine patch therapy	Standard n=54 Participants This arm receives eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture. nicotine patch: 8-week nicotine patch therapy	Total n=109 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	52 Participants n=7 Participants	105 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	50.69 years STANDARD_DEVIATION 8.41 • n=5 Participants	48.76 years STANDARD_DEVIATION 10.08 • n=7 Participants	49.73 years STANDARD_DEVIATION 9.28 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	45 Participants n=7 Participants	91 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	54 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Korean Americans

The number of participants who had maintained smoking abstinence for the past 12 months

Outcome measures

Measure	Cultural Tailoring n=55 Participants The 12-month prolonged abstinence was defined as being continuously abstinent from the quit day except for the first 2-week grace period. Self-reported abstinence was biochemically verified with expired-air CO (\< 6 parts ppm) and saliva cotinine (≤ 30ng/ml) tests. We used a Micro+ Smokerlyzer CO Monitor (Bedfont Scientific, NJ) and NicAlert® test strips.	Brief Cessation Counseling n=54 Participants The 12-month prolonged abstinence was defined as being continuously abstinent from the quit day except for the first 2-week grace period. Self-reported abstinence was biochemically verified with expired-air CO (\< 6 parts ppm) and saliva cotinine (≤ 30ng/ml) tests. We used a Micro+ Smokerlyzer CO Monitor (Bedfont Scientific, NJ) and NicAlert® test strips.
12-month Abstinence	21 Participants	6 Participants

SECONDARY outcome

Timeframe: 6-month follow-up

Population: Korean Americans

Perceived family norm toward quitting smoking was assessed using the Perceived Family Norm Index consisting of two items assessing normative beliefs (i.e., "I believe that my family [my friends] wants me to quit smoking") and motivation to comply with the belief (i.e., "I am willing to comply with the belief"). Score for each item can range from -3 "strongly disagree" to +3 "strongly agree". The total score is the sum of the scores of the two items and can range from -6 to +6.

Outcome measures

Measure	Cultural Tailoring n=55 Participants The 12-month prolonged abstinence was defined as being continuously abstinent from the quit day except for the first 2-week grace period. Self-reported abstinence was biochemically verified with expired-air CO (\< 6 parts ppm) and saliva cotinine (≤ 30ng/ml) tests. We used a Micro+ Smokerlyzer CO Monitor (Bedfont Scientific, NJ) and NicAlert® test strips.	Brief Cessation Counseling n=54 Participants The 12-month prolonged abstinence was defined as being continuously abstinent from the quit day except for the first 2-week grace period. Self-reported abstinence was biochemically verified with expired-air CO (\< 6 parts ppm) and saliva cotinine (≤ 30ng/ml) tests. We used a Micro+ Smokerlyzer CO Monitor (Bedfont Scientific, NJ) and NicAlert® test strips.
Perceived Family Norm Toward Quitting Smoking	5.14 score on a scale Interval 3.0 to 6.0	4.81 score on a scale Interval 2.0 to 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-month follow-ups

Population: Korean Americans who had smoked at least 10 cigarettes a day for the past 6 months before study enrollment.

The salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml).

Outcome measures

Measure	Cultural Tailoring n=55 Participants The 12-month prolonged abstinence was defined as being continuously abstinent from the quit day except for the first 2-week grace period. Self-reported abstinence was biochemically verified with expired-air CO (\< 6 parts ppm) and saliva cotinine (≤ 30ng/ml) tests. We used a Micro+ Smokerlyzer CO Monitor (Bedfont Scientific, NJ) and NicAlert® test strips.	Brief Cessation Counseling n=54 Participants The 12-month prolonged abstinence was defined as being continuously abstinent from the quit day except for the first 2-week grace period. Self-reported abstinence was biochemically verified with expired-air CO (\< 6 parts ppm) and saliva cotinine (≤ 30ng/ml) tests. We used a Micro+ Smokerlyzer CO Monitor (Bedfont Scientific, NJ) and NicAlert® test strips.
Biochemical Verification of Self-reported Abstinence	21 Participants	6 Participants

Adverse Events

Cultural Tailoring

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Brief Cessation Counseling

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cultural Tailoring n=55 participants at risk The group who received a deep Korean-culture tailored smoking cessation intervention.	Brief Cessation Counseling n=54 participants at risk The group who received a standard non-culture tailored smoking cessation intervention.
Skin and subcutaneous tissue disorders skin reaction	100.0% 3/3 • Number of events 3 • 1 year There was no case of participants at risk for other adverse events.	100.0% 2/2 • Number of events 2 • 1 year There was no case of participants at risk for other adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sun S Kim

University of Massachusetts Medical School

Phone: 201-388-2656

Email: sun.kim@umb.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place