Status:
COMPLETED
Effects of Chantix on Relapse Prevention for Smoking Cessation
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
AstraZeneca
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed...
Detailed Description
The proposed human experiment will test the validity of a novel paradigm that may provide a method for distinguishing compounds that are likely to have efficacy from those that are not, before they ar...
Eligibility Criteria
Inclusion
- Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.
Exclusion
- Smoking Behavior
- Use of chewing tobacco or snuff
- Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
- Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
- Provide a baseline CO reading \< 10 ppm
- Alcohol/Drug Exclusion Criteria
- History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
- 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:
- Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)
- 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 as identified by the SCID.
- Serious or unstable disease within the past 6 months (e.g., cancer \[except melanoma\], 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).
- Wears a device to aid in hearing (hearing aid, cochlear implant, etc.).
- Hearing threshold \< 40 dB SPL at 1000 Hz.
- Color blindness.
- 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.
- Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00948649
Start Date
September 1 2006
End Date
September 1 2007
Last Update
August 17 2010
Active Locations (1)
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1
Tobacco Use Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104