Cocaine Dependence Clinical Trial
Official title:
Levetiracetam (Keppra) Tolerability and Efficacy in Cocaine Abusing Methadone-maintained Patients.
The proposed investigation will use methadone maintained patients who have concurrent cocaine dependence in order to take advantage of the excellent (over 80%) treatment retention in this patient group and to maximize treatment compliance by daily observed medication with both methadone and levetiracetam. In the initial patients we will explore the tolerability of escalating doses of levetiracetam as well as its potential role in reducing cocaine use, as monitored by self-report and verified by three-times weekly urine toxicology testing in methadone treated patients.The specific aim of this study is to evaluate the tolerability and efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients
This 12-week open-label clinical trial will provide treatment for 15 cocaine-dependent
opioid dependent patients. Participants, aged 18-65 years, will receive levetiracetam 3000
mg/day while concurrently receiving treatment with methadone. Baseline cocaine use will be
determined during the first week of treatment participation.
The study design will have three overlapping phases that are summarized below: 1) A one week
methadone fixed induction (week 1) and flexible stabilization phase (weeks 2-9); 2) an
8-week "treatment" phase (weeks 2-9), consisting of slow titration and stabilization on
study medication; and 3) a four week "taper, detoxification or transfer" phase (weeks 9-12).
During the first week of induction onto methadone, participants will be administered fixed
increasing doses of methadone starting at 30 mg daily and increased to 60 mg daily by the
end of the first week. This methadone dose will be adjusted for stabilization of opiate
withdrawal symptoms using a flexible dosing from 40 mg up to 150 mg. This range has been
found to be adequate for the vast majority of patients receiving methadone in our program
and is designed to accommodate participants who may not be able to tolerate the higher
maintenance doses or may still experience withdrawal symptoms, respectively. We may increase
or decrease this amount on a case-by-case basis based on physician assessment of
self-reported and observed symptoms.
Starting on week 2 subjects will receive levetiracetam 500mg/day and this dose will be
slowly titrated to a total of 3000mg/day or maximum tolerated dose (MTD). Subjects will
remain on their full dosage through week 8.
At the end of week 8, participants will undergo detoxification from methadone over a 4-week
period (weeks 8-12) and discontinuation from levetiracetam over a concurrent 2-week period.
All participants will receive weekly 1-hour of individual psychotherapy (Cognitive
Behavioral Treatment) with experienced clinicians specifically trained to deliver the
therapy and who will receive ongoing supervision. The primary outcomes will be reported
medication side effects (medication tolerability), and 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. This study will occur at the Outpatient Treatment Research
Program in Building 36 at the VA CT Healthcare System.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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