Recent research on the effects of nicotine on the brain and behavior presents an opportunity
to advance medication development.
The purpose of this study is to develop a laboratory model for early-stage testing of new
and existing treatments for nicotine addiction. Specifically, we will develop a laboratory
model of smoking relapse in nicotine dependent volunteers.
Tobacco use is the leading preventable cause of death in the United States. Recent research
on the effects of nicotine on the brain and behavior presents an opportunity to advance
medication development. The goal of this study is to develop a laboratory model for
early-stage testing of new and existing compounds for the treatment of tobacco and nicotine
addiction. In addition, the objective of this study is to develop a laboratory model of
relapse induced by cigarette exposure that would reproduce the psychological and
physiological processes that are involved when abstinent individuals progress from initial
cigarette smoking (lapse) to a pre-abstinence level of use (relapse). Such a model may be
used to study the mechanisms of relapse and to screen medications that might be effective in
preventing relapse in treatment seekers.
This study will consist of two phases. Each phase will consist of a 5-day inpatient stay.
During the first portion of inpatient stay, participants will not be permitted to smoke.
During the second portion of inpatient stay, smoking reinstatement will be modeled, as
participant will have opportunity to smoke, following the exposure to tobacco-related or
control cues. A variety of behavioral, subjective, physiological, and performance measures
will be assessed throughout the study.
- DSM-IV diagnosis of nicotine dependence with psychological dependence
- Smokes at least 15 cigarettes per day for the three months prior to enrollment
- Currently not seeking treatment for nicotine dependence
- Medically healthy, on the basis of physical examination and medical history, vital
signs, EKG, and laboratory tests
- Females must use an effective method of contraception for the duration of the study
- DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications within
the 3 months prior to enrollment
- History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety
- Currently seeking treatment for nicotine disorders
- On parole or probation
- History of seizures or head trauma with loss of consciousness, brain contusion, or
- History of significant recent violent behavior
- Blood pressure greater than 150/90
- History of eating disorders