Levetiracetam (Keppra) Tolerability in Cocaine Abusing Methadone-maintained Patients. (Keppra)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Levetiracetam (Keppra) Tolerability and Efficacy in Cocaine Abusing Methadone-maintained Patients.|
- Medication emergent side-effects [ Time Frame: 12-weeks ] [ Designated as safety issue: Yes ]
- Thrice weekly urine toxicology [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Weekly self-report of cocaine and opioid use [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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 not be blind to the subject's medication administration. The medication will be discontinued over a two-week period
Other Name: Keppra
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593125
|United States, Connecticut|
|VA CT Healthcare System|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Gerardo Gonzalez, MD||Yale University|