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Study Summary
No. 2004-0806:.......Psychosocial......Jennifer Irvin Vidrine......Health Disparities Research
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Study Summary Title
Study Summary
Number:
2004-0806
Study Title:Health Communications and Risk Processing Among Smokers
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Physician New Patient Referral
Name:Jennifer Irvin VidrinePatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Health Disparities ResearchReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-2383
Contact us about clinical trials
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General Information
Disease Group:PsychosocialSupported By:N/A
Phase of Study:Phase IReturn
Visit:
After the initial baseline study visit, participants will return to MDACC for
four additional visits.
Treatment
Agents:
NoneHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this behavioral research study is to put together and study a
treatment for nicotine dependence that looks at how your thoughts and feelings
about smoking may be related to how successfully you quit smoking.
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Study Objectives / Outcomes
To the best of our knowledge, this study will be the first to 1) examine changes in risk perceptions over time in the natural environment, and 2) to evaluate potential mechanisms underlying changes in risk perceptions using palmtop computer-administered EMA procedures and two implicit cognition tasks. Participants will be community smokers (N=200) recruited from the greater Houston area and will be tracked from one week prior to their quit date through three weeks after their quit date using state-of-the-science ecological momentary assessment (EMA) procedures (Stone & Shiffman, 1994). All participants will receive smoking cessation treatment consisting of nicotine patch therapy, minimal contact smoking cessation counseling, and self-help materials. Smoking-relevant health risk perceptions will be assessed using behavioral/psychological assessment technologies - EMA and "implicit" cognition psychological measures – as well as computer-administered questionnaires. The specific aims are to:

1. Compare real-time changes in smoking-relevant risk perceptions over time among smokers who successfully abstain from smoking and those who relapse during a minimal contact cessation intervention.
2. Examine the relationship between contextual factors including affective state, craving, smoking, and levels of perceived smoking-relevant risk over time utilizing real-time assessments.
3. Examine the relationship between risk perceptions assessed in the natural environment over time, a standard questionnaire measure of risk perception, and implicit associations in memory between smoking, disease, and fear using implicit cognition task data, and to compare the relative strength of these associations among abstainers and relapsers.
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Study Status Information
Study Activation / Registration Date:02/10/2006
IRB Review and Approval Date:12/15/2004
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Age 18 to 65 years.

2) Current smoker with a history of at least 5 cigarettes/day for the last year

3) Motivated to quit within the next week.

4) Home address and a functioning home telephone number.

5) Can speak, read, and write in English at a sixth-grade literacy level.

Exclusion Criteria:1) Contraindication for nicotine patch use.

2) Active substance abuse or dependence.

3) Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless).

4) Use of bupropion or nicotine products other than the nicotine patches supplied by the study.

5) Pregnancy or lactation.

6) Another household member enrolled in the study.

7) Participation in a smoking cessation program or study during the past 90 days.

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Links
Registration Number: NCT00384696
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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