Status:
COMPLETED
Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Depressive Symptoms
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 c...
Detailed Description
Subjects enrolled in this 12-wk, double blind, randomized, placebo-controlled, clinical trial are admitted to a residential facility in North Little Rock (RCA-NLR) and randomized by depressive symptom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00654953
Start Date
January 1 2006
End Date
May 1 2009
Last Update
April 25 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205 7911