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Tobacco Dependence Treatment for Asian Americans

A Randomized Controlled Clinical Trial of a Combination of Pharmacotherapy and Culturally Tailored Cognitive Behavior Therapy With Korean Americans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01091363
Enrollment
109
Registered
2010-03-24
Start date
2009-10-31
Completion date
2014-01-31
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Dependence

Keywords

smoking cessation, tobacco dependence treatment, cultural adaptation, Asian Americans

Brief summary

Nicotine dependence is very common among Asian Americans; yet, research on understanding and treating nicotine dependence in this group is almost nonexistent. The proposed study is a first attempt to develop a smoking cessation program that is tailored to Korean-culture specific aspects. It is proposed that Korean Americans who receive a culturally tailored smoking cessation program will be more likely to have prolonged abstinence at 12-month follow-up than their counterparts who receive brief cessation counseling. Subjects in both arms receive nicotine patches for 8 weeks. Self-reported abstinence is validated with exhaled carbon monoxide and salivary cotinine tests.

Detailed description

Korean men have been known for very high smoking rates and the highest cancer death smoking-attributable fraction. In contrast, Korean women reportedly smoke at low rates compared to the general U.S. population. However, recent population-based survey data indicate steady increases in smoking prevalence of Korean American women. Particularly, it has been found that they tend to initiate smoking as they acculturate into social norms of American women. Preliminary data of the applicant and others suggests interventions must be culturally adapted and a motivation-based and family-involved approach is most promising. The training plan will help the applicant develop an independent program of drug abuse research that focuses on better understanding and treating tobacco dependence among Asian Americans, including evaluating culturally competent and gender-specific interventions. The research plan will examine the impact of culture and gender on nicotine dependence and utilize National Institute on Drug Abuse behavioral therapy development methods. The proposed research plan has two-phases and evaluates tobacco dependence treatment with Korean Americans (N = 164, 50% women). Phase 1 is a no-control group study (Stage Ia) that is aimed at developing an intervention manual of Group-based Motivational Interviewing (GMI) intervention, therapists' adherence and competence scales, training program, and small feasibility intervention study with 20 Korean-American (offered separately for men and women). Phase 2 is a randomized controlled trial (Stage Ib) with 144 Korean Americans that is conducted to assess feasibility and relative effectiveness of the GMI behavioral intervention in conjunction with Nicotine Replacement Therapy (NRT) in comparison with a brief group medication management of NRT. Gender-interaction effects of psychosocial variables on treatment outcomes will be assessed, including acculturation and depression. This award will help prepare the applicant for an independent research career focusing on Asian Americans and Nicotine Dependence, including adapting and testing new interventions for different populations.

Interventions

BEHAVIORALStandard

10 minute brief cessation counseling

BEHAVIORALDeep Cultural

Deep culturally tailored cognitive behavioral therapy

Sponsors

University of Massachusetts, Boston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Korean-speaking Koreans who: 1. Are ages of 18 and older 2. Have been smoking at least 10 or more cigarettes on average per day for the past 30 days; AND 3. Are willing to quit smoking and receive NRT

Exclusion criteria

1. Inability to speak and understand Korean or English 2. Involvement in behavioral or other pharmacological smoking cessation programs 3. History of serious cardiac diseases and/or presence of skin diseases (see Human Subjects); OR 4. Pregnancy, lactation or plans to become pregnant in the next 12 months

Design outcomes

Primary

MeasureTime frameDescription
12-month Abstinence12 monthsThe number of participants who had maintained smoking abstinence for the past 12 months

Secondary

MeasureTime frameDescription
Perceived Family Norm Toward Quitting Smoking6-month follow-upPerceived 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.

Other

MeasureTime frameDescription
Biochemical Verification of Self-reported Abstinence12-month follow-upsThe salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml).

Countries

United States

Participant flow

Recruitment details

2010-2013.

Pre-assignment details

232 people were screened and 123 were excluded before randomization.

Participants by arm

ArmCount
Deep Cultural
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
55
Standard
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
54
Total109

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22
Overall StudyWithdrawal by Subject1115

Baseline characteristics

CharacteristicTotalDeep CulturalStandard
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants2 Participants2 Participants
Age, Categorical
Between 18 and 65 years
105 Participants53 Participants52 Participants
Age, Continuous49.73 years
STANDARD_DEVIATION 9.28
50.69 years
STANDARD_DEVIATION 8.41
48.76 years
STANDARD_DEVIATION 10.08
Region of Enrollment
United States
109 participants55 participants54 participants
Sex: Female, Male
Female
18 Participants9 Participants9 Participants
Sex: Female, Male
Male
91 Participants46 Participants45 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 550 / 54
serious
Total, serious adverse events
3 / 552 / 54

Outcome results

Primary

12-month Abstinence

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

Time frame: 12 months

Population: Korean Americans

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cultural Tailoring12-month Abstinence21 Participants
Brief Cessation Counseling12-month Abstinence6 Participants
p-value: <0.0195% CI: [1.67, 12.99]Regression, Logistic
Secondary

Perceived Family Norm Toward Quitting Smoking

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.

Time frame: 6-month follow-up

Population: Korean Americans

ArmMeasureValue (MEAN)
Cultural TailoringPerceived Family Norm Toward Quitting Smoking5.14 score on a scale
Brief Cessation CounselingPerceived Family Norm Toward Quitting Smoking4.81 score on a scale
Comparison: Mediation analyses were performed to examine the effect of the intervention on abstinence via the three theoretic variables (attitudes, perceived family norms, and self-efficacy), using the Hayes' PROCESS computation tool for a serial multiple mediator model with a binary outcome variable (quitting vs. smoking).p-value: 0.0295% CI: [0.34, 6.32]Mediation Analysis
Other Pre-specified

Biochemical Verification of Self-reported Abstinence

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

Time frame: 12-month follow-ups

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cultural TailoringBiochemical Verification of Self-reported Abstinence21 Participants
Brief Cessation CounselingBiochemical Verification of Self-reported Abstinence6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026