Status:
COMPLETED
A Multi-Modal Investigation of the Smoking Cessation Medication Varenicline: Dopaminergic Modulation of Reward Processing and Cognitive Control
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Nicotine Dependence
Eligibility:
All Genders
18-55 years
Brief Summary
Background: * Chronic nicotine exposure through cigarette smoking affects the level of the brain chemical dopamine. Smokers who attempt to quit experience lower levels of dopamine, which increases an...
Detailed Description
Objective. Chronic nicotine exposure is thought to lead to alterations in the dopamine (DA) system that leaves smokers in a hypo-dopaminergic state during periods of abstinence. Varenicline (Chantix),...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- between the ages of 18-55.
- right-handed.
- in good health.
- free of active DSM-IV dependence, or dependence in partial remission, on alcohol or any drug except nicotine. Past active dependence is acceptable provided it is at least five years in the past and total time of active dependence did not exceed 4 years. Those with past dependence may not have any current use (past 6 months) of the substance on which they were dependent.
- able to abstain from alcohol 24hrs before each of the imaging sessions and able to moderate their caffeine intake 12hrs before each session.
- In addition, smokers must:
- smoke 10 or more cigarettes per day and have smoked for more than 2 years.
- be able to refrain from smoking for up to 12hrs (at 6 different time points) during the study.
- be able to tolerate the nicotine patch.
- In addition, non-smokers must:
- (1) Not have a history of daily cigarette smoking lasting more than a month and no smoking within the past 2 years.
- EXCLUSION CRITERIA:
- are not suitable to undergo an fMRI experiment due to certain implanted devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology, or claustrophobia.
- have coagulopathies, history of, current superficial, or deep vein thrombosis, musculoskeletal abnormalities restricting an individual s ability to lie flat for extended periods of time.
- have HIV or Syphilis.
- regularly use any prescription, over-the-counter or herbal medication that may alter CNS function, cardiovascular function, or neuronal-vascular coupling.
- have any current, or a history of, neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, history of significant head trauma, or CNS tumor.
- have any current, or a history of, major psychiatric disorders, substance-induced psychiatric disorders, suicidal ideations and/or suicide attempts, or currently under antidepressant or antipsychotic medication treatment.
- are cognitively impaired or learning disabled.
- have significant cardiovascular or cerebrovascular conditions.
- have moderate to severe renal impairment.
- are diabetic.
- have any other major medical condition that in the view of the investigators would compromise the safety of an individual during participation.
- pregnant, planning to become pregnant, or breastfeeding.
Exclusion
Key Trial Info
Start Date :
November 25 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 26 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00830739
Start Date
November 25 2008
End Date
February 26 2013
Last Update
July 5 2018
Active Locations (1)
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1
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, United States, 21224