- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00596882
Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Transdisciplinary Tobacco Use Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- History of substance abuse and/or currently receiving treatment for substance abuse
- Current alcohol consumption that exceeds >25 standard drinks/week
Medication Exclusion Criteria
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
- Any heart medications
- Daily medication for asthma
Medical Exclusion Criteria
- Women who are pregnant, planning a pregnancy, or lactating.
- History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder.
- Serious/unstable disease within the past 6 months (e.g., cancer [but melanoma], heart disease, HIV).
- History of epilepsy or a seizure disorder.
- 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).
- History of kidney and/or liver failure (including transplant).
General Exclusion
- Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 1
Threat only message.
Participants hear information about the negative health consequences of smoking
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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.
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Other: 2
Genetic threat + threat.
Participants will bear infomration about genetic influences of smoking in additon to the negative health consequences of smoking.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Schnoll, Ph.D., University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 806910
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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