Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223639
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2005-09-19
Brief Title:
New Medications to Treat Alcohol Dependence
Sponsor:
Bankole Johnson
Organization:
University of Virginia
Study Overview
Official Title:
New Medications to Treat Alcohol Dependence
Status:
COMPLETED
Status Verified Date:
2012-02
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:
In the last decade there has been an explosion of new knowledge of the neuroscientific basis of alcohol-seeking behavior Briefly medications that modulate mesolimbic dopamine pathways by facilitating gamma amino butyric function and inhibiting the action of excitatory amino acids should reliably diminish alcohols rewarding effects Topiramate a sulfamate-substituted fructo-pyranose derivative has these characteristics In support of this concept we have shown in a phase-II-type medications clinical trial that topiramate is significantly superior to placebo at improving drinking outcomes and decreasing craving among N 150 alcohol-dependent individuals Using the carefully controlled environment of the human laboratory we are submitting a revised application containing a set of systematic studies to assess directly the mechanistic neuropharmacological processes that are associated with topiramates anti-drinking effects This will provide a more comprehensive understanding of the neurobiology of alcohol-seeking behavior and aid in the development of even more effective compounds for the treatment of alcohol dependence Thus the specific aims of the project are to 1 determine the dose-relationship of acute effects of topiramate to reduce alcohol effects related to its abuse and addiction potential We hypothesize that topiramate will reduce alcohol-induced craving reward and euphoria 2 determine whether chronic treatment with an acutely effective dose of topiramate produces substantial reductions in alcohol-related cue-induced craving thereby decreasing the potential for treatment relapse We hypothesize that chronic topiramate administration will desensitize reduce alcohol craving produced by alcohol-related sensory cues and 3 determine whether topiramate interactions with and without alcohol are associated with neurocognitive impairment Clinical studies including ours have suggested that topiramate use may be associated with neurocognitive effects such as loss of concentration and memory impairment In our own study these effects were mild and not associated with reduced treatment compliance Since alcohols ability to produce neurocognitive impairment may be mediated through similar ionic mechanisms to that of topiramate the proposed human laboratory setting affords us the unique opportunity to more clearly delineate topiramates neurocognitive effects in both the presence and absence of alcohol This study supports NIAAAs goal to develop effective medications for treating alcoholism and to understand the basic underpinnings of the disease
Detailed Description:
None
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 |
|---|---|---|---|
| 5R01AA014628-02 | NIH | None | httpsreporternihgovquickSearch5R01AA014628-02 |