Efficacy of Levetiracetam in Cocaine-Abusing Methadone Maintained Patients

NCT00577005 | Completed Phase 2 Results DMC

• 5 other identifiers: 07070028325R01DA017782-04NIDA-5R01DA017782-04Yale-0508000534VA-gg0006
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Dependence; Opioid Dependency

Keywords

GABAergic; levetiracetam

Outcome Measures

Primary Outcomes (1)

• Change of Thrice Weekly Cocaine Free Urine Toxicology From Week 1 to 13

  The primary outcome variable was the change from baseline to week 13 of the thrice weekly cocaine-free urine scores. In this repeated ordinal variable, 0 represented all 3 urine samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urine samples submitted by the subjects were negative for cocaine. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data is summarized as number of participant that were cocaine free urine (score 2) per week by group.

  Weekly from baseline to week 12

Secondary Outcomes (3)

• Change of Thrice Weekly Opioid Free Urine Toxicology From Week 1 to 13

  Weekly from baseline to week 12

• Treatment Retention

  Week 13

• Cocaine Craving

  Weekly from baseline to week 12

Study Arms (2)

1

EXPERIMENTAL

Levetiracetam tablets

Drug: levetiracetam

2

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

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 be blind to the subject's medication administration. The medication will be discontinued over a two-week period.

1

Placebo DRUG

2

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 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.

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
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

VA CT Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gerardo Gonzalez, MD
• Organization: University of Massachusetts Medical School

gerardo.gonzalez@umassmed.edu

508 856 6480

Study Officials

• Gerardo Gonzalez, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 17, 2018
• Results First Posted: April 24, 2017

Record last verified: 2018-01

Locations

US (1)