Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study
NCT00596882
ABOUT THIS STUDY
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1. Women who are pregnant, planning a pregnancy, or lactating.
2. History or current diagnosis of psychosis, major depression or bipolar disorder,
schizophrenia, or any Axis 1 disorder.
3. Serious/unstable disease within the past 6 months (e.g., cancer [but melanoma], heart
disease, HIV).
4. History of epilepsy or a seizure disorder.
5. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia
(>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease
(stroke, angina, coronary heart disease), heart attack in the last 6 months,
uncontrolled hypertension (SBP>150 or DBP>90).
6. History of kidney and/or liver failure (including transplant).
General Exclusion
1. Any medical condition or concomitant medication that could compromise participant
safety or treatment, as determined by the Principal Investigator and/or Study
Physician.
2. Inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator and/or Study Physician.
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Descriptive Information | ||||
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Brief Title ICMJE | Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study | |||
Official Title ICMJE | Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study | |||
Brief Summary | The proposed study has been designed to examine the effect of a message that primes genetic susceptibility on actual enrollment in a smoking cessation program, actual response to smoking cessation treatment, and potential moderators and mediators of this effect. | |||
Detailed Description | Despite available behavioral and pharmacological interventions to treat nicotine dependence, most smokers do not utilize these interventions. As such, the vast majority of smokers do not capitalize on potentially effective nicotine dependence treatments. The way in which health risk information is presented may influence interest in a smoking cessation program. In a series of preliminary studies, individuals provided with messages that primed the role of genetic variation in susceptibility to addiction to smoking exhibited positive consequences on intentions to quit (Cappella, Lerman, Romantan, & Baruh, 2005). The proposed study has been designed to examine the effect of a message that primes genetic susceptibility on actual enrollment in a smoking cessation program, actual response to smoking cessation treatment, and potential moderators and mediators of this effect. The results of this pilot study may provide preliminary data for a larger trial and have implications for designing interventions to promote utilization of effective treatments for nicotine dependence among smokers. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Smoking Cessation | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 100 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2009 | |||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Eligible participants will be 100 male & female smokers aged 18-65, who smoke ? 10 cigarettes/day & who plan to live in the area for the next 6-months. Key Exclusion Criteria Smoking Behavior 1.Use of chewing tobacco or snuff 2.Current enrollment or plans to enroll in another smoking cessation program in the next 6 months 3.Plan to use other nicotine substitutes or smoking cessation treatments in the next 6 months Alcohol/Drug Exclusion Criteria
Medication Exclusion Criteria
Medical Exclusion Criteria
General Exclusion
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00596882 | |||
Other Study ID Numbers ICMJE | 806910 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Robert Schnoll, Ph.D., University of Pennsylvania | |||
Study Sponsor ICMJE | University of Pennsylvania | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Pennsylvania | |||
Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |