Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2

Not Applicable

Completed

Brief Summary: 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, the investigators will develop a laboratory model of relapse to cigarette use in nicotine dependent volunteers.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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 disorders
Currently seeking treatment for nicotine disorders
On parole or probation
History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
History of significant recent violent behavior
Blood pressure greater than 150/90
History of eating disorders
Pregnant

Arm && Interventions

Group	Intervention	Description
Neutral Cue first, then Active Cue	Neutral or active cigarette cues	Each participant receives two consecutive interventions. 1. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue 2. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
Active Cue first, then Neutral Cue	Neutral or active cigarette cues	Each participant receives two consecutive interventions. 1. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue. 2. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue

Primary Outcome Measures

Name	Time	Method
Cigarette Choice After 3 Day Abstinence	During Day 4 experimental session	Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices

Secondary Outcome Measures