Levetiracetam (Keppra) Tolerability in Cocaine Abusing Methadone-maintained Patients.

NCT00593125 | Completed Phase 2

• 3 other identifiers: Yale-0508000534UBC,IncVA HSS GG 0004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine Dependence; Opioid Dependence

Keywords

cocaine; opioids; heroin; levetiracetam

Outcome Measures

Primary Outcomes (1)

• Medication emergent side-effects

  12-weeks

Secondary Outcomes (2)

• Thrice weekly urine toxicology

  12 weeks

• Weekly self-report of cocaine and opioid use

  12-weeks

Study Arms (1)

1

EXPERIMENTAL

levetiracetam

Drug: levetiracetam

Interventions

levetiracetam DRUG

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

Also known as: Keppra

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA CT Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Opioid-Related Disorders

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gerardo Gonzalez, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 14, 2008
• Study Start: January 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2008
• Last Updated: January 12, 2017

Record last verified: 2016-09

Locations

US (1)