Prometa Protocol for Alcohol Dependence

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

February 29, 2008

Study Completion Date

March 31, 2008

Conditions
Alcohol Dependence
Interventions
DRUG

Flumazenil and Gabapentin

2 mg flumazenil for infusion given slowly over 20 minutes given day 1 and day 2 gabapentin 300 mg increasing to 1200 mg over 4 days and continuing to day 30. Gabapentin 900 mg Day 31 to Day 33 gabapentin 600 mg Day 34 to 36 and gabapentin 300 mg Day 37 to 39.

DRUG

Placebo

20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.

Trial Locations (1)

29425

MUSC-Center for Drug and Alcohol Programs, Charleston

All Listed Sponsors
lead

Medical University of South Carolina

OTHER

NCT00262639 - Prometa Protocol for Alcohol Dependence | Biotech Hunter | Biotech Hunter