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
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.
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.
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.
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
Current use or recent discontinuation (within last 14-days) of the following medications:
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
Medical Exclusion Criteria
General Exclusion
Threat only message. Participants hear information about the negative health consequences of smoking
Other: Message Prime
Genetic threat + threat. Participants will bear infomration about genetic influences of smoking in additon to the negative health consequences of smoking.
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.
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.
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
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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