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

NCT ID: NCT00596882

Last Updated: 2009-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Smoking Cessation

Keywords

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smoking cessation nicotine dependence message prime recruitment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

Message Prime

Intervention Type OTHER

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.

Message Prime

Intervention Type OTHER

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.

2

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

Group Type OTHER

Message Prime

Intervention Type OTHER

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.

Message Prime

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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


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


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennsylvania Department of Health

OTHER_GOV

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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University of Pennsylvania

Principal Investigators

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Robert Schnoll, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Transdisciplinary Tobacco Use Research Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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806910

Identifier Type: -

Identifier Source: org_study_id