NCT00654953|CompletedPhase 2ResultsDMC
Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans
Sertraline Augmented With GABA Agents for Cocaine Dependence
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Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
102
1 country
1
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertraline alone or combined with gabapentin delays time to relapse relative to placebo in recently abstinent cocaine-dependent volunteers who are also depressed. In addition, whether depressive symptoms or genetic factors influence treatment response to the study medications will be examined. Our hypothesis is that those on combined sertraline-gabapentin will show a longer period of abstinence than those on sertraline alone or placebo.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 4, 2008
Actual (reported)April 9, 2008
Actual (reported)May 2009
Actual (reported)May 2009
Actual (reported)April 25, 2011
Actual (reported)Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites
Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine.
70 days
Placebo capsules
sertraline (200 mg/day)
sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
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.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205 7911, United States
Alison Oliveto, PhD
University of Arkansas
102 participants (actual enrollment reported by the registry).
First Submitted
April 4, 2008
First Posted
April 9, 2008
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Effects of Vigabatrin on Cocaine Self-Administration
Placebo (cellulose or lactose) administered twice per day for 12 weeks.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
April 25, 2011
Results First Posted
April 25, 2011
Record last verified: 2011-03
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Source: ClinicalTrials.gov.
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