Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Cocaine DependenceDepressive Symptoms
Interventions
DRUG

sertraline

Sertraline hydrochloride (200 mg/day) will be administered once daily. While subjects are at RCA-NLR they initially receive 50 mg/day of sertraline. This dose is gradually increased over a 3-week period until subjects receive 200 mg. When subjects are transferred to the outpatient program, they will be administered capsules once weekly, with take-home doses given in blister packs to take once a day for the rest of the week.

DRUG

Placebo

Placebo (cellulose or lactose) administered twice per day for 12 weeks.

DRUG

gabapentin

Gabapentin (Neurontin; Parke-Davis; 1200 mg/day) will be administered twice daily. Initially, patients will receive 200 mg twice daily on days 1-5, 400 mg twice daily on days 6-10, then 600 mg twice daily on days 11 on. Subjects are then maintained on this dose for the duration of the trial, unless side-effects are too severe, in which case the dose of gabapentin is decreased to no less 800 mg/day. If symptoms persist, subjects' participation would then be terminated.

Trial Locations (1)

72205 7911

University of Arkansas for Medical Sciences, Little Rock

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of Arkansas

OTHER

NCT00654953 - Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans | Biotech Hunter | Biotech Hunter