Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2008
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedDecember 2, 2009
December 1, 2009
1.3 years
January 8, 2008
December 1, 2009
Conditions
Keywords
Outcome Measures
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
1 year
Study Arms (2)
1
OTHERThreat only message. Participants hear information about the negative health consequences of smoking
2
OTHERGenetic threat + threat. Participants will bear infomration about genetic influences of smoking in additon to the negative health consequences of smoking.
Interventions
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.
Eligibility Criteria
You may not qualify if:
- History of substance abuse and/or currently receiving treatment for substance abuse
- Current alcohol consumption that exceeds \>25 standard drinks/week
- Current use or recent discontinuation (within last 14-days) of the following medications:
- Any form of smoking cessation medication
- 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).
- Medication for chronic pain
- Anti-coagulants
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Pennsylvania Department of Healthcollaborator
- Pfizercollaborator
Study Sites (1)
Transdisciplinary Tobacco Use Research Center
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Schnoll, Ph.D.
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 8, 2008
First Posted
January 17, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
December 2, 2009
Record last verified: 2009-12