Status:
COMPLETED
Human Laboratory Study Of Varenicline in Smokers
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Pfizer
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this study is to test the ways that a drug called varenicline helps smokers to quit smoking. Varenicline is also called Chantix® and is approved by the United States Food and Drug Admin...
Detailed Description
The purpose of this study is to understand the therapeutic mechanisms of varenicline, a novel nicotinic analogue, through focused measures of potential psychological and physiological mediators. Varen...
Eligibility Criteria
Inclusion
- 1. Who. Subjects will be women and men between the ages of 18 and 40 who have smoked at least 10 cigarettes per day for at least 1 year. They will respond to requests in the public media for individuals who are interested in quitting smoking.
- 2. Total sample/Number per group. The total randomized sample size will equal 20 subjects, equally distributed across the two medication groups.
- 3. Inclusion Criteria.
- 18 years to 60 years.
- Smoke Marlboro Lights (This criterion was selected to reduce inter-subject variation in response variables as has been done in many human laboratory studies of smoking behavior. Over 40% of all smokers smoke some type of the Marlboro brand of cigarette (Substance Abuse and Mental Health Services Administration, 2005). Based on telephone screen data for 767 subjects collected at TURC, Marlboro Light cigarettes are the most common type of Marlboro smoked in our sampling population (158/252 Marlboro users \[63%\]). Therefore, we have decided to only enroll those smoking Marlboro Light cigarettes, non-menthol).
- Smoked at least 10 cigarettes/day for at least 1 year.
- English speaking and reading.
- Females who are of childbearing potential must practice effective contraception and meet the following criteria:
- Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
- Have a negative urine pregnancy test at baseline.
- Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.
- Willingness to not use illicit drugs during study period including marijuana.
Exclusion
- Concurrent use of tobacco products (other than cigarettes) or nicotine products.
- Medications that might affect the outcome measures of nicotine reward, cognition, anxiety, and stress will also be a basis for exclusion. These medications include psychotropic drugs (i.e., anti-psychotic, anti-depressant, anti-anxiety, or stimulant), anti- hypertensive agents (e.g., beta-blockers), and other drugs that can influence the outcome domains.
- History of kidney disease or renal impairment since varenicline is primarily excreted by the kidney and thus such patients are vulnerable to increased and potentially toxic levels of varenicline.
- Treatment for drug or alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol.
- Suicidal or homicidal ideation.
- History of bipolar disorder, schizophrenia, schizoaffective disorder, attention deficit disorder, or attention deficit hyperactivity disorder.
- Current major depression or anxiety disorder.
- Pregnant or lactating or planning pregnancy during treatment period.
- Having plans to leave the immediate geographical area within 2 months.
- Unwillingness or inability to give written informed consent.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00709696
Start Date
April 1 2008
End Date
December 1 2009
Last Update
December 27 2017
Active Locations (1)
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1
Tobacco Use Research Center
Minneapolis, Minnesota, United States, 55414