Efficacy of Levetiracetam in Cocaine-Abusing Methadone Maintained Patients
Condition: Cocaine Dependence; Opioid Dependency
MeSH terms: Cocaine-Related Disorders
Intervention: levetiracetam; Placebo
Intervention description: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period.
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: GABAergic; levetiracetam

Summary:

      Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent
      patients in spite of methadone maintenance treatment being highly effective for opiate
      dependence and having excellent treatment retention. Cocaine dependence has remained largely
      unresponsive to medications both in and outside of these methadone programs. We have initial
      data from our open-label study with levetiracetam showing that this medication is well
      tolerated and may reduce cocaine use in this cocaine-abusing methadone treated population.

      The specific aim of this study is to evaluate the efficacy of levetiracetam 3 grams/day in
      modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's
      reinforcing effect among methadone-maintained patients. The primary outcomes will be
      reduction in cocaine use as assessed by self-report and thrice-weekly urinalyses. Secondary
      outcomes will include weeks in treatment (retention) and change in measures of cocaine
      craving, anxiety symptoms and opiate withdrawal symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 18-65 years.

          -  Participants must demonstrate current opioid dependence as determined by study
             physician or APRN, self-reported history of opioid dependence for one year and a
             positive urine of opiates. Participants may be transferred from other methadone
             maintenance programs, including the WHVA methadone program.

          -  Participants also must be current users of cocaine with self-reported use of cocaine >
             1 time/week in at least one month preceding study entry, cocaine-positive urine screen
             and score over 3 as assessed with the Severity Dependence Scale.

          -  Women of childbearing age are eligible to be included in the study if they have a
             negative pregnancy test at screening, agree to adequate contraception to prevent
             pregnancy, to have monthly pregnancy tests, and they understand the risk of fetal
             toxicity due to medication and cocaine.

        Exclusion Criteria:

          -  Current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or
             tobacco).

          -  Patients with serious medical illness (e.g., major cardiovascular, renal, endocrine,
             hepatic, and serious neurological disorders including any history of seizures).

          -  Patients with current serious psychiatric illness or history of psychosis,
             schizophrenia, bipolar type I disorder and subjects with suicidal or homicidal
             thoughts or taking psychotropic medications.

          -  Women who are pregnant, nursing or refuse to use a reliable form of birth control or
             refuse monthly testing.

          -  Screening liver function tests (SGOT or SGPT) greater than 3 times normal and renal
             function test (creatinine) greater than 1.5 mg/dl.