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Trial record 1 of 1 for:    NCT00596882
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Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00596882
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : December 2, 2009
Sponsor:
Collaborators:
Pennsylvania Department of Health
Pfizer
Information provided by:
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE January 8, 2008
First Posted Date  ICMJE January 17, 2008
Last Update Posted Date December 2, 2009
Study Start Date  ICMJE February 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2008)
The primary outcome variables are:(1)Attendance to the intake evaluation & enrollment in the smoking cessation program; (2)7-day point prevalence abstinence(3)Self-reported cigarette consumption [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Other: Message Prime
    Participants will be randomized to genetic prime messages or threat only message at the time of the intial telephone screen. Following phone screen, all eligibleparticipants will receive 13 weeks of Chantix with smoking cessation counseling.
  • Other: Message Prime
    Particpants will be randomized into 1 of 2 groups. 1 group will recieve a message detailing the negative helaht consequenes of smoking and the other group will receive this information along with information about the genetic incluences on smoking behavior.
Study Arms  ICMJE
  • 1
    Threat only message. Participants hear information about the negative health consequences of smoking
    Interventions:
    • Other: Message Prime
    • Other: Message Prime
  • 2
    Genetic threat + threat. Participants will bear infomration about genetic influences of smoking in additon to the negative health consequences of smoking.
    Interventions:
    • Other: Message Prime
    • Other: Message Prime
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
 (submitted: January 16, 2008)
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

  1. History of substance abuse and/or currently receiving treatment for substance abuse
  2. Current alcohol consumption that exceeds >25 standard drinks/week

Medication Exclusion Criteria

  1. Current use or recent discontinuation (within last 14-days) of the following medications:

    1. Any form of smoking cessation medication
    2. Any form of anti-psychotic medications that includes:

      •antipsychotics,

      •atypical antipsychotics,

      •mood-stabilizers,

      •anti-depressants (tricyclics, SSRI's, MAOI's),

      •anti-panic agents,

      •anti-obsessive agents,

      •anti-anxiety agents, and

      • stimulants (e.g., Provigil, Ritalin).
    3. Medication for chronic pain
    4. Anti-coagulants
    5. Any heart medications
    6. Daily medication for asthma

Medical Exclusion Criteria

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
  • Pennsylvania Department of Health
  • Pfizer
Investigators  ICMJE
Principal Investigator: Robert Schnoll, Ph.D. University of Pennsylvania
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