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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Gabapentin; gamma-Aminobutyric Acid; Sertraline

Criteria

Inclusion Criteria:

• 18-65 years old

• not currently enrolled in a treatment program

• subjects must have a history of cocaine use, with street cocaine use by history being a minimum of 1 gram during the preceding 3 months

• subjects must meet DSM-IV criteria for cocaine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID and SCID-SAC)

• subjects must have laboratory confirmation of recent cocaine use (positive urine for cocaine or benzoylecgonine) during the month prior to study entry

• subjects must score at least 15 on the Hamilton Depression Scale

• women of childbearing age must have a negative pregnancy test to enroll in this study and must agree to monthly pregnancy testing

Exclusion Criteria:

• current diagnosis of other drug or alcohol physical dependence (other than cocaine or tobacco)

• ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)

• history of schizophrenia, or bipolar type I disorder

• present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested

• medical contraindication to receiving study medications (e.g., for sertraline, use of monoamine oxidase inhibitor within last two weeks; significant history of seizures; significant history of head trauma or serious neurological disorders)

• current suicidality or psychosis

• Liver function tests (i.e., liver enzymes) greater than three times normal levels

• pregnancy