Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262639
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2005-12-05
Brief Title:
Prometa Protocol for Alcohol Dependence
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Double Blind Evaluation of Flumazenil and Gabapentin for the Treatment of Alcohol Withdrawal and Relapse Prevention
Status:
COMPLETED
Status Verified Date:
2019-02
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:
This is a placebo controlled trial some people receive active and some people receive inactive medication to evaluate the effectiveness of a new protocol to treat alcohol dependence Two main medications plus ancillary non-placebo controlled medications and their placebos inactive drugs will be utilized to treat both alcohol withdrawal promote abstinence and reduce drinking over approximately a six-week treatment period All participants will meet criteria for Alcohol Dependence and be drinking heavily up until 72 hours prior to receiving the first study drug They will be injected one drug flumazenil or placebo over a two day period and receive the second one gabapentin or placebo by mouth for 39 days The main hypothesis is that this protocol will reduce early alcohol withdrawal symptoms and will reduce relapse to drinking and promote abstinence compared to the placebo inactive drug group Secondary outcomes that will be evaluated include reduction in craving improvement in sleep brain activity and mood
Detailed Description:
Approximately 60 alcohol dependent individuals who are drinking heavily up until 72 hours or less prior to study participation will be randomized to receive either flumazenil intravenouslyon two successive days and gabapentin orallyfor 39 days or their matching placebos They also will receive hydroxyzine and vitamins Individuals will be evaluated for alcohol withdrawal their response to acoustic startle cognitive ability craving mood sleep and drinking during the first week They will then be seen weekly for about 6 weeks during which they take gabapentin or placebo and are provided with Combined Behavioral Intervention Therapy counseling once a week or more as required Over this period they will be evaluated weekly for alcohol consumption craving sleep mood and biological markers of alcohol consumption percent carbohydrate deficient transferrin and gamma-glutamyl transferase Blood will be obtained on week 3 and 6 for general health liver blood count etc screening After the end of treatment subjects will be followed-up at 4 weeks and again at 8 weeks after treatment to evaluate alcohol consumption craving sleep mood
Subjects will undergo a functional magnetic resonance imaging MRI procedure sometime during the second or third week of study medication to assess cue induced regional brain activation to investigate the effect of medication on brain response to alcohol visual cues
Subjects will undergo a functional magnetic resonance imaging MRI procedure sometime during the second or third week of study medication to assess cue induced regional brain activation to investigate the effect of medication on brain response to alcohol visual cues
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