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 study will develop a cigarette smoking relapse model in order to determine the effect of smoking exposure on smoking relapse followed by brief abstinence.

Condition	Intervention	Phase
Tobacco Use Disorder	Behavior: Neutral or active cigarette cues	Phase II

Further Study Details: 

Primary Outcomes: Smoking Relapse, Day 5
Expected Total Enrollment:  12

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. Specifically, the study will develop a cigarette smoking relapse model in order to determine the effect of smoking exposure on smoking relapse following brief abstinence.

This study will consist of two phases. Each phase will consist of a 5-day inpatient stay. Participants will be randomly assigned to receive either neutral or active cues. The neutral cue will consist of a glass and a bottle of spring water. The active (cigarette) cue will consist of an unopened pack of the participants'''' preferred brand of cigarette, a lighter, matches, and an ashtray.

After initial screening, participants will receive a single cigarette. This will be followed by a baseline assessment to determine the effects of a cigarette in the non-deprived state. During the first 3 days of inpatient stay, participants will no longer be permitted to smoke. Abstinence will be verified using carbon monoxide measurements. Three laboratory sessions per day will be conducted during Days 1 through 3. Signs and symptoms of nicotine withdrawl will be assessed. On Days 4 and 5, smoking reinstatement will occur. At this time, participants will choose between acquiring money and purchasing cigarette puffs with money earned during Days 1 through 3. Smoking behavior and physiological measures associated with smoking relapse will be evaluated.

Ages Eligible for Study:  21 Years   -   45 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• DSM-IV diagnosis of nicotine dependence with psychological dependence
• Smokes at least 15 cigrattes 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:

• 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 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00136838

New York
      Columbia University, New York,  New York,  10023,  United States; Recruiting

Study chairs or principal investigators

Adam Bisaga, M.D.,  Principal Investigator,  New York State Psychiatric Institute   

Study ID Numbers:  NIDA-17572-2; R01-17572-2
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136838
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30