One of nicotine''''s effects on the body is at the level of the NMDA receptors in the brain. Memantine is a drug that also affects NMDA receptors, making it a promising candidate for the treatment of nicotine addiction. The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. In order to do so, the study will evaluate the effectiveness of memantine versus bupropion for altering smoking relapse.

Condition	Intervention	Phase
Tobacco Use Disorder	Drug: Memantine	Phase III

Further Study Details: 

Primary Outcomes: Smoking Relapse, Day 15
Expected Total Enrollment:  24

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. Neurotransmission at NMDA receptors in the brain is associated with learning and memory and has been linked to many of nicotine''''s effects on humans. It is possible that altering NMDA neurotransmission may be a way to effectively treat nicotine addiction. 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 determine the effect of memantine, an NMDA antagonist, versus bupropion in altering smoking relapse.

This double-blind study will consist of three phases (placebo, bupropion, and memantine). Each phase will include 10 days of outpatient medication maintenance, followed by 5 days of inpatient testing. During the outpatient phase, study visits will occur every 2 to 3 days. During the inpatient phase, participants will be randomly assigned to either a neutral or active cue. 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 participant''''s preferred brand of cigarette, a lighter, matches, and an ashtray. These cues will be presented at various times. After initial screening, participants will receive a single cigarette, which 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. During the last 2 days of inpatient stay, smoking reinstatement will occur. At this time, participants will choose between money and the option to smoke. Smoking behavior and pysiological measures will be evaluated.

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

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 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

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 three 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
• History of allergic reaction to any of the study medications
• Pregnant

Please refer to this study by ClinicalTrials.gov identifier  NCT00136786

New York
      New York State Psychiatric Institute, New York,  New York,  10032,  United States

Study chairs or principal investigators

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

Study ID Numbers:  NIDA-17572-3; R01-17572-3
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136786
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30