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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Behavioral: Deep Cultural; Behavioral: Standard

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02125
      • University Massachusetts Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: deep cultural arm; deep cultural therapy	Behavioral: Deep Cultural; Deep culturally tailored cognitive behavioral therapy
Active Comparator: standard arm; brief cessation counseling	Behavioral: Standard; 10 minute brief cessation counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month Abstinence	The number of participants who had maintained smoking abstinence for the past 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12-month follow-ups

Collaborators and Investigators

• Sponsor: University of Massachusetts, Boston
• Investigators: Principal Investigator: Sun S Kim, PhD, University of Massachusetts, Worcester

Publications and helpful links

General Publications

• Kim SS, Kim SH, Ziedonis D. Tobacco dependence treatment for Korean Americans: preliminary findings. J Immigr Minor Health. 2012 Jun;14(3):395-404. doi: 10.1007/s10903-011-9507-0.
• Kim SS, Kim SH, Fang H, Kwon S, Shelley D, Ziedonis D. A Culturally Adapted Smoking Cessation Intervention for Korean Americans: A Mediating Effect of Perceived Family Norm Toward Quitting. J Immigr Minor Health. 2015 Aug;17(4):1120-9. doi: 10.1007/s10903-014-0045-4.
• Kim SS, Fang H, Bernstein K, Zhang Z, DiFranza J, Ziedonis D, Allison J. Acculturation, Depression, and Smoking Cessation: a trajectory pattern recognition approach. Tob Induc Dis. 2017 Jul 24;15:33. doi: 10.1186/s12971-017-0135-x. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 21, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (Estimate): March 24, 2010

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: smoking cessation; tobacco dependence treatment; cultural adaptation; Asian Americans
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 5K23DA021243-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Upon request, the data will be sent.
• IPD Sharing Time Frame: October 2009-September 2016
• IPD Sharing Access Criteria: Researchers at non-profit academic institutions
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)