Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136786
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2005-08-25
Brief Title:
Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
One of nicotines 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 nicotines 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | OTHER | NIDA | httpsreporternihgovquickSearchR01DA017572 |
| R01DA017572 | NIH | None | None |