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| Sponsor: | New York State Psychiatric Institute |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00136786 |
Purpose
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. We will compare the effects of memantine with bupropion, medication currently used to facilitate smoking cessation.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Use Disorder |
Drug: Memantine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals |
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2006 |
| 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 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.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | New York State Psychiatric Institute ( Adam Bisaga, MD, Principal Investigator ) |
| Study ID Numbers: | NIDA-17572-3, R01DA017572, DPMC |
| Study First Received: | August 25, 2005 |
| Last Updated: | December 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00136786 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Tobacco Use Disorder Physiological Effects of Drugs Disorders of Environmental Origin Antiparkinson Agents Excitatory Amino Acid Agents |
Pharmacologic Actions Mental Disorders Therapeutic Uses Substance-Related Disorders Memantine Dopamine Agents Central Nervous System Agents Excitatory Amino Acid Antagonists |