Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans
Condition: Cocaine Dependence; Depressive Symptoms
MeSH terms: Cocaine-Related Disorders; Depression
Intervention: sertraline; Placebo; gabapentin
Intervention description: 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.; 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.
Intervention MeSH terms: Gabapentin; Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cocaine dependence; depressive symptoms; relapse; sertraline; gabapentin

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.
    

Eligibility 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