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 treatment with memantine versus bupropion for nicotine dependency.

Condition	Intervention	Phase
Tobacco Use Disorder	Drug: Memantine	Phase III

Further Study Details: 

Primary Outcomes: Response to cigarette cues, Days 11-13; Smoking behavior, Days 11-13
Expected Total Enrollment:  48

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 assess the effect of memantine, a non-competitive NMDA antagonist, versus bupropion on various physical and psychological aspects related to smoking behaviors.

This double-blind study will consist of three distinct phases for each of three treatments: placebo, bupropion, and memantine. Each phase will include 10 days of outpatient medication, followed by 3 days of inpatient testing. Participants will be randomly assigned to receive placebo, bupropion, or memantine. During the outpatient phase, study visits will occur every 2 to 3 days. At these visits, compliance and side effects of medication will be monitored, smoking diaries will be collected, and medication will be dispensed. During the inpatient period, participants will spend nights at the Biological Studies Unit (BSU), which is where the study procedures will take place. Participants will be allowed to smoke only at designated times. Vital signs and carbon monoxide levels will be monitored. Participants will also be evaluated while performing various smoking behavior tests. For example, their physical and psychological reactions to cigarettes will be measured. Participants will be discharged at the end of the third day of the inpatient period.

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  NCT00136747

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

Study chairs or principal investigators

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

Study ID Numbers:  NIDA-17572-1; R01-17572-1
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136747
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30