Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals|
- Use of cigarettes [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: Intervention 1
Each participant receives three consecutive interventions.
Placebo Comparator: Intervention 2
Placebo Comparator: Intervention 3
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 helpful in treating nicotine addiction. The goal of this study is to evaluate the effects of memantine, an NMDA receptor antagonist, using the laboratory model of smoking relapse in nicotine dependent volunteers. The effects of memantine used in combination with bupropion, a medication currently used to facilitate smoking cessation, will be compared to a placebo.
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 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. A variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136786
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Adam Bisaga, M.D.||New York State Psychiatric Institute|