Official Title: “Sertraline Augmented With GABA Agents for Cocaine Dependence”

To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with the 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-gabapent will show a longer period of abstinence than those on sertraline alone or placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2009

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 severity to receive one of the following: sertraline alone (200 mg/day), sertraline (200 mg/day) plus gabapentin (1200 mg/day), or placebo. Subjects are expected to participate in the Substance Abuse Day Treatment Program while residing on the RCA-NLR and being inducted onto the maintenance dose of study medication (weeks 1-2). When participants transfer to the Outpatient Treatment Research Unit (TRU) at the start of their third week, they will continue to receive study medications or placebo (weeks 3-12) and they will be expected to participate in weekly individual cognitive behavioral therapy. Compliance with study requirements during weeks 3-12 will be facilitated through the use of contingency management procedures (see below), whereby subjects are given monetary compensation for attendance and for returning blister packs. Supervised urines and vital signs will be obtained thrice weekly; self-reported adverse effects, mood and drug use self-reports will be obtained once weekly. At the end of 12 weeks, participants will be tapered off the study medication over a five-day period, discharged from the study, and referred to an appropriate treatment or treatment/research program in the community if they are interested.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo capsules
• Experimental: 2
  • sertraline (200 mg/day)
• Experimental: 3
  • sertraline (200 mg/day) plus gabapentin (1,200 mg/day)

Primary Measures

• Urine toxicology results for cocaine/metabolite or other illicit drugs
  • Time Frame: thrice-weekly for 12 weeks
    Safety Issue?: No

Secondary Measures

• scores on Ham-D
  • Time Frame: weekly for 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Overall Contact: Letha McGarity, BS (501) 526-7911 LGMcgarity@uams.edu

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654953

Study ID Number: P50-DA018197

ClinicalTrials.gov Identifier: NCT00654953

Health Authority: United States: Federal Government