Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398918
Status:
COMPLETED
Last Update Posted:
2017-07-14
First Post:
2006-11-13
Brief Title:
Alcohol Self Administration Laboratory
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Alcohol Self Administration Laboratory
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This is a pilot study in which our intent is to establish an alcohol administration laboratory in which we will be able to test the effect of the anticonvulsant medication zonisamide as compared to placebo on alcohol self administration and on cognitive functioning in non treatment seeking heavy users of alcohol Our first goal is to establish the safety of zonisamide when used together with alcohol Our second goal is to test the effect of an acute dose of zonisamide on alcohol consumption and show that it may reduce the consumption of alcohol To achieve this goal we seek subjects with a history of heavy drinking to be tested on the self-administration procedures described below in two sessions with either zonisamide or placebo These procedures will involve first the administration of a challenge dose of ethanol to evaluate the effect of alcohol on performance on neuropsychological tests This initial challenge will be followed by a period of alcohol self-administration in which the research subject can choose to select either ethanol or another reinforcer money
Detailed Description:
In preclinical studies three novel anticonvulsants have been studied The administration of tiagabine did not decrease ethanol consumption in rodents Schmitt et al 2002 Rimondini et al 2002 In a study with alcohol preferring mice topiramate reduced alcohol consumption in a two bottle choice prolonged access model of drinking Gabriel and Cunningham 2005 In a study done at our laboratory both topiramate and zonisamide were found to have similar effects on reducing the consumption of ethanol in Wistar rat Knapp et al 2004 More recently we found that zonisamide administration decreased alcohol consumption in a limited access model in the C57BLB6 mouse These results suggest that zonisamide might be useful as a medication for the treatment of alcohol dependence
Topiramate and zonisamide have some structural similarities with a sulfamate or methane-sulfonamide containing chain respectively attached to cyclic structure These structural similarities may explain some of their pharmacological similarities including blockade of voltage sensitive sodium channels and low potency inhibition of carbonic anhydrase Taverna et al 1999 Dodgson et al 2000 Schaf et al 1987 Masudaet al 1993 Both topiramate and zonisamide promote weight loss McElroy et al 2003 McElroy et al 2004 Gadde et al 2003 This effect may be a result of neuromodulation of the regulation of alcohol and food shared by these drugs
Topiramate and zonisamide have some structural similarities with a sulfamate or methane-sulfonamide containing chain respectively attached to cyclic structure These structural similarities may explain some of their pharmacological similarities including blockade of voltage sensitive sodium channels and low potency inhibition of carbonic anhydrase Taverna et al 1999 Dodgson et al 2000 Schaf et al 1987 Masudaet al 1993 Both topiramate and zonisamide promote weight loss McElroy et al 2003 McElroy et al 2004 Gadde et al 2003 This effect may be a result of neuromodulation of the regulation of alcohol and food shared by these drugs
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