Tobacco Dependence Treatment for Asian Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091363
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : May 30, 2014
Information provided by (Responsible Party):
Sun Kim, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: nicotine patch Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of a Combination of Pharmacotherapy and Culturally Tailored Cognitive Behavior Therapy With Korean Americans
Study Start Date : September 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: cultural tailoring
eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT
Drug: nicotine patch
8-week nicotine patch therapy

Active Comparator: brief cessation counseling
This arm receives eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture.
Drug: nicotine patch
8-week nicotine patch therapy

Primary Outcome Measures :
  1. Prolonged Abstinence [ Time Frame: 09/2009-5/2013 ]
    Of the 109 participants, 77 were due for the 1-year follow-up assessment that is the endpoint of this study. Those who were not available were treated as smoking. Using an intent-to-treat analysis, 35.9% of participants in the cultural intervention arm and 13.2% of participants in the brief counseling arm (odds ratio = 3.7, 95% confidence interval = 1.2-11.6, p = 0.03) had 12-month prolonged abstinence.

Secondary Outcome Measures :
  1. predictors of cessation outcome and gender difference in baseline data [ Time Frame: 09/2009-05/2013 ]
    Controlling for self-efficacy and treatment condition, baseline nicotine dependence was also a strong predictor of the 12-month prolonged abstinence (OR = 1.7, 95% CI = 1.2-2.5, p = 0.004). However, unlike our expectation, individuals with higher dependence were more likely to have the abstinence than their counterparts. This finding remained significant even after controlling for gender. The overall survival of subjects who had prolonged abstinence was significantly higher in the treatment arm than in the control arm (log rank test, p = 0.003). Combining Stage I-a and I-b Studies, women were more likely to be single or divorced (χ2 =17.6, p < 0.00l) and smoke at home (χ2 =6.0, p = 0.02), and live with other smokers (χ2 =14.1, p = 0.00l) than men. Women reported more severe symptoms of nicotine withdrawal (t = 2.46, p = 0.03) after quitting than did men.

Other Outcome Measures:
  1. Biochemical verification of self-reported abstinence [ Time Frame: 09/01/2009-05/01/2013 ]
    The primary outcome of the study, prolonged abstinence, was biochemically verified prolonged abstinence at 12-month follow-up. The CO level was measured by Micro+ Smokelyzer CO Monitor (Bedfont Scientific, NJ) and its cutoff level is 6 parts per million (ppm). The salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091363

United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01652
Sponsors and Collaborators
University of Massachusetts, Worcester
Principal Investigator: Sun S. Kim, PhD University of Massachusetts, Worcester

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sun Kim, Study Principle Investigator, University of Massachusetts, Worcester Identifier: NCT01091363     History of Changes
Other Study ID Numbers: 5K23DA021243-02 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by Sun Kim, University of Massachusetts, Worcester:
smoking cessation
tobacco dependence treatment
cultural adaptation
Asian Americans

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action