NCT01091363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

March 13, 2019

Completed
Last Updated

March 13, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

March 21, 2010

Results QC Date

November 10, 2014

Last Update Submit

February 20, 2019

Conditions

Tobacco Dependence

Keywords

smoking cessationtobacco dependence treatmentcultural adaptationAsian Americans

Outcome Measures

Primary Outcomes (1)

  • 12-month Abstinence

    The number of participants who had maintained smoking abstinence for the past 12 months

    12 months

Secondary Outcomes (1)

  • Perceived Family Norm Toward Quitting Smoking

    6-month follow-up

Other Outcomes (1)

  • Biochemical Verification of Self-reported Abstinence

    12-month follow-ups

Study Arms (2)

deep cultural arm

EXPERIMENTAL

deep cultural therapy

Behavioral: Deep Cultural

standard arm

ACTIVE COMPARATOR

brief cessation counseling

Behavioral: Standard

Interventions

StandardBEHAVIORAL

10 minute brief cessation counseling

standard arm
Deep CulturalBEHAVIORAL

Deep culturally tailored cognitive behavioral therapy

deep cultural arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Korean-speaking Koreans who:
  • Are ages of 18 and older
  • Have been smoking at least 10 or more cigarettes on average per day for the past 30 days; AND
  • Are willing to quit smoking and receive NRT

You may not qualify if:

  • Inability to speak and understand Korean or English
  • Involvement in behavioral or other pharmacological smoking cessation programs
  • History of serious cardiac diseases and/or presence of skin diseases (see Human Subjects); OR
  • Pregnancy, lactation or plans to become pregnant in the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

Related Publications (3)

  • 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.

    PMID: 21785963RESULT

  • 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/s10903-014-0045-4.

    PMID: 24878686RESULT

  • Kim SS, Fang H, Bernstein K, Zhang Z, DiFranza J, Ziedonis D, Allison J. Acculturation, Depression, and Smoking Cessation: a trajectory pattern recognition approach. Tob Induc Dis. 2017 Jul 24;15:33. doi: 10.1186/s12971-017-0135-x. eCollection 2017.

    PMID: 28747857DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Results Point of Contact

Title
Dr. Sun S Kim
Organization
University of Massachusetts Medical School
sun.kim@umb.edu
201-388-2656

Study Officials

  • Sun S Kim, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principle Investigator

Study Record Dates

First Submitted

March 21, 2010

First Posted

March 24, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

March 13, 2019

Results First Posted

March 13, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

Upon request, the data will be sent.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
October 2009-September 2016
Access Criteria
Researchers at non-profit academic institutions
More information

Locations

US(1)