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Tobacco Dependence Treatment for Asian Americans

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ClinicalTrials.gov Identifier: NCT01091363
Recruitment Status : Completed
First Posted : March 24, 2010
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sun S Kim, University of Massachusetts, Boston

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 Behavioral: Standard Behavioral: Deep Cultural Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Clinical Trial of a Combination of Pharmacotherapy and Culturally Tailored Cognitive Behavior Therapy With Korean Americans
Study Start Date : October 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: 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




Primary Outcome Measures :
  1. 12-month Abstinence [ Time Frame: 12 months ]
    The number of participants who had maintained smoking abstinence for the past 12 months


Secondary Outcome Measures :
  1. Perceived Family Norm Toward Quitting Smoking [ Time Frame: 6-month follow-up ]
    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.


Other Outcome Measures:
  1. Biochemical Verification of Self-reported Abstinence [ Time Frame: 12-month follow-ups ]
    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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01091363


Locations
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United States, Massachusetts
University Massachusetts Boston
Boston, Massachusetts, United States, 02125
Sponsors and Collaborators
University of Massachusetts, Boston
Investigators
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Principal Investigator: Sun S Kim, PhD University of Massachusetts, Worcester
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sun S Kim, Study Principle Investigator, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT01091363    
Other Study ID Numbers: 5K23DA021243-02 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2010    Key Record Dates
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request, the data will be sent.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: October 2009-September 2016
Access Criteria: Researchers at non-profit academic institutions
URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4250475/pdf/nihms-600738.pdf
Keywords provided by Sun S Kim, University of Massachusetts, Boston:
smoking cessation
tobacco dependence treatment
cultural adaptation
Asian Americans
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders