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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Tobacco Dependence

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prolonged Abstinence

Outcome Description:

Seventy-seven Korean immigrants participated in a Stage 1-b study (a pilot clinical trial). At 6-month follow-up (based on currently available data), 46.2% and 15.8% of participants in intervention and control condition, respectively (odds ratio = 4.57, 95% confidence interval = 1.56-13.40, P = 0.004) had prolonged abstinence (having not smoked even a puff after the first two-week grace period from the quit day). Participants' self-reported abstinence is biochemically verified with exhaled carbon monoxide and salivary cotinine levels.

Outcome Time Frame:

09/2009-04/2012

Safety Issue:

No

Principal Investigator

Sun S. Kim, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Massachusetts, Worcester

Authority:

United States: Institutional Review Board

Study ID:

5K23DA021243-02

NCT ID:

NCT01091363

Start Date:

September 2009

Completion Date:

March 2014

Related Keywords:

  • Tobacco Dependence
  • smoking cessation
  • nicotine patch
  • Tobacco Use Disorder

Name

Location

University of Massachusetts Medical SchoolWorcester, Massachusetts  01605