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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01188018
Other study ID # 00023726
Secondary ID 1R01CA133068-01A
Status Completed
Phase Phase 3
First received August 24, 2010
Last updated July 3, 2012
Start date October 2010
Est. completion date June 2012

Study information

Verified date July 2012
Source University of Missouri, Kansas City
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine, among a sample of general adult smokers, the effectiveness of three different counseling interventions for motivating quit attempts among smokers not yet ready to quit.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years and older

- Smoke at least once a day for the past 30 days

- Are willing to participate in all study components

- Sufficient language skills in English for counseling and assessments

- Has a home address

- Has a working phone number

Exclusion Criteria:

- Pregnant or planning to become pregnant in the next 6 months

- Currently using a smoking cessation medication

- Currently participating in smoking cessation program

- Motivated to quit smoking

- Planning to quit smoking in the next 2 weeks

- Lives in a home with someone currently enrolled in the study

- Minor

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Intervention

Behavioral:
Brief Advice (BA)
Participants in this arm will receive a single session of brief advice. A counselor will briefly discuss the risks associated with smoking.
Motivational Interviewing (MI)
Subjects will receive 4 counseling sessions (over 18 weeks) in which their thoughts about their smoking will be discussed. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone(weeks 6 and 18).
Health Education (HE)
Subjects will receive 4 counseling sessions (over 18 weeks)in which they will receive educational information about the risks of smoking and the benefits of quitting. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone (weeks 6 and 18).

Locations

Country Name City State
United States University of Missouri-Kansas City Kansas City Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of Missouri, Kansas City National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. — View Citation

Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. Review. — View Citation

Soria R, Legido A, Escolano C, López Yeste A, Montoya J. A randomised controlled trial of motivational interviewing for smoking cessation. Br J Gen Pract. 2006 Oct;56(531):768-74. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Quit Attempt(s) Any time within 26 weeks No
Secondary Smoking Cessation 7 days No
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