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Tobacco Dependence Treatment for Asian Americans

U

University of Massachusetts, Worcester

Status

Completed

Conditions

Tobacco Dependence

Treatments

Behavioral: Standard
Behavioral: Deep Cultural

Study type

Interventional

Funder types

Other

Identifiers

NCT01091363
5K23DA021243-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

109 participants in 2 patient groups

deep cultural arm
Experimental group
Description:
deep cultural therapy
Treatment:
Behavioral: Deep Cultural
standard arm
Active Comparator group
Description:
brief cessation counseling
Treatment:
Behavioral: Standard

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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