Viewing Study NCT00249691



Ignite Creation Date: 2024-05-05 @ 12:06 PM
Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00249691
Status: UNKNOWN
Last Update Posted: 2012-03-08
First Post: 2005-11-03

Brief Title: Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1
Sponsor: Bankole Johnson
Organization: University of Virginia

Study Overview

Official Title: Medication Development for Cocaine Dependence
Status: UNKNOWN
Status Verified Date: 2012-03
Last Known Status: ACTIVE_NOT_RECRUITING
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: Although a great amount of research has been conducted to resolve cocaine dependence an effective treatment has yet to be discovered Topiramate is a drug that was found to be useful in treating alcohol dependence The purpose of this study is to determine the effectiveness of topiramate in treating cocaine dependent individuals
Detailed Description: Despite considerable scientific effort in the last two decades to develop treatment for cocaine dependent individuals no medication has proven to be effective for treating cocaine dependence Cocaines rewarding effects are primarily a result of altering nerve pathways involving dopamine a naturally-occurring chemical in the brain Past research has focused on developing medications that either block dopamine or inhibit its release However these medications have not proven effective in treating cocaine dependence This study will evaluate a new strategy of treating cocaine dependence by altering dopamines functional expression Dopamine-associated expression may be mediated through inhibition of gamma-aminobutyric acid GABA another brain chemical Topiramate is a GABA inhibitor that has proven effective in treating alcohol dependent individuals The purpose of this study is to determine the efficacy of topiramate in treating cocaine dependent individuals

Participants will be randomly assigned to receive either 300 mg per day of topiramate or placebo In addition participants will receive weekly cognitive behavioral therapy for 12 weeks Follow-up visits will occur at 2 weeks and 1 2 and 3 months following completion of treatment and will include evaluations of cocaine use and psychosocial functioning

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 httpsreporternihgovquickSearchR01DA017296
R01DA017296 NIH None None