The Effects of Memantine and Bupropion on Acute, Reinforcing, and Conditioned Effects of Cigarettes - 1
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Developing Medication For Tobacco Addiction: NMDA Agents|
- Response to cigarette cues [ Time Frame: Days 11-13 ] [ Designated as safety issue: No ]
- Smoking behavior [ Time Frame: Days 11-13 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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 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, a medication currently used to facilitate smoking cessation, on various behavioral aspects related to smoking behavior, including reinforcement and cue-reactivity.
This double-blind, randomized assignment study will consist of three distinct phases (placebo, bupropion, and memantine). Each phase will include 10 days of outpatient medication maintenance, followed by 3 days of inpatient testing. 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 be allowed to smoke only at designated times. A variety of assessment will be conducted, including abstinence symptoms, acute effects of cigarettes, responses to cigarette cues, and cigarette self-administration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136747
|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|