- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593125
Levetiracetam (Keppra) Tolerability in Cocaine Abusing Methadone-maintained Patients. (Keppra)
Levetiracetam (Keppra) Tolerability and Efficacy in Cocaine Abusing Methadone-maintained Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516
- VA CT Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between the ages of 18-65 years.
- Participants must demonstrate current opioid dependence as determined by study physician, 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 (Kaye & Darke 2002).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
levetiracetam
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medication emergent side-effects
Time Frame: 12-weeks
|
12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Thrice weekly urine toxicology
Time Frame: 12 weeks
|
12 weeks
|
Weekly self-report of cocaine and opioid use
Time Frame: 12-weeks
|
12-weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerardo Gonzalez, MD, Yale University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yale-0508000534
- UBC,Inc
- VA HSS GG 0004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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