Tobacco Dependence Treatment for Asian Americans

Tobacco Dependence Clinical Trial

Official title:

A Randomized Controlled Clinical Trial of a Combination of Pharmacotherapy and Culturally Tailored Cognitive Behavior Therapy With Korean Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091363
• Other study ID #: 5K23DA021243-02
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: January 2014

Study information

• Verified date: February 2019
• Source: University of Massachusetts, Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Standard
10 minute brief cessation counseling
• Deep Cultural
Deep culturally tailored cognitive behavioral therapy

Locations

Country	Name	City	State
United States	University Massachusetts Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	12-month Abstinence	The number of participants who had maintained smoking abstinence for the past 12 months	12 months
Secondary	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