CClinicalTrials.gg
CompletedNCT00596882Updated Dec 2, 2009

Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study

A Phase 4 interventional study of Message Prime and Message Prime in Smoking Cessation, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-02.

Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Smoking Cessation

Keywords

  • smoking cessation
  • nicotine dependence
  • message prime
  • recruitment
03

In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    1

    Threat only message. Participants hear information about the negative health consequences of smoking

    Other: Message Prime

  • Other
    2

    Genetic threat + threat. Participants will bear infomration about genetic influences of smoking in additon to the negative health consequences of smoking.

    Other: Message Prime

Interventions

  • OtherMessage 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.

  • OtherMessage 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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Transdisciplinary Tobacco Use Research Center
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00596882
Lead sponsor
University of Pennsylvania
Collaborators
Pennsylvania Department of Health, Pfizer
First posted
Jan 17, 2008
Start date
Feb 2008
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Dec 2, 2009

Study contacts

Robert Schnoll, Ph.D.
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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