Tobacco Dependence Treatment for Asian Americans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Kim, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01091363
First received: March 21, 2010
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Tobacco Dependence
Drug: nicotine patch
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Prolonged Abstinence [ Time Frame: 09/2009-5/2013 ] [ Designated as safety issue: No ]
    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:
  • predictors of cessation outcome and gender difference in baseline data [ Time Frame: 09/2009-05/2013 ] [ Designated as safety issue: No ]
    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:
  • Biochemical verification of self-reported abstinence [ Time Frame: 09/01/2009-05/01/2013 ] [ Designated as safety issue: No ]
    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).


Enrollment: 131
Study Start Date: September 2009
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01091363

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

Publications:
Responsible Party: Sun Kim, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01091363     History of Changes
Other Study ID Numbers: 5K23DA021243-02
Study First Received: March 21, 2010
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014