Clinical Trials Directory

Trials / Completed

CompletedNCT00136786

Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3

Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
25 (actual)
Sponsor
New York State Psychiatric Institute · Academic / Other
Sex
All
Age
21 Years – 45 Years
Healthy volunteers
Accepted

Summary

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 candidate for the treatment of nicotine addiction. The purpose of this study is to evaluate the effectiveness of memantine using a laboratory model of smoking relapse in nicotine dependent volunteers. Investigators will compare the effects of memantine with bupropion, medication currently used to facilitate smoking cessation.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGMemantine

Timeline

Start date
2006-12-01
Primary completion
2009-05-01
Completion
2009-05-01
First posted
2005-08-29
Last updated
2018-05-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00136786. Inclusion in this directory is not an endorsement.