NCT00577005: Keppra-DB

Levetiracetam (Keppra) Treatment for Cocaine Dependence in Methadone-Maintained Patients

Completed Phase 2 Results posted Last updated 12 January 2018

What this trial tests

Phase 2 trial testing levetiracetam in Cocaine Dependence in 28 participants. Completed in 1 October 2008.

Timeline

1 July 2007

Primary endpoint
1 June 2008

1 October 2008

Quick facts

Lead sponsor	Yale University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	28
Start date	1 July 2007
Primary completion	1 June 2008
Estimated completion	1 October 2008
Sites	1 location across United States

Drugs / interventions tested

• levetiracetam (levetiracetam) — full drug profile →
• Placebo

Conditions studied

• Cocaine Dependence — all drugs for Cocaine Dependence →
• Opioid Dependency — all drugs for Opioid Dependency →

Sponsor

Yale University

Who can join

Adults 18 to 65, any sex, with Cocaine Dependence or Opioid Dependency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change of Thrice Weekly Cocaine Free Urine Toxicology From Week 1 to 13
  Time frame: Weekly from baseline to week 12
  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 t

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Anticonvulsants for cocaine dependence.
   Minozzi S, Cinquini M, Amato L, Davoli M, et al · · 2015 · cited 22× · PMID 25882271 · DOI 10.1002/14651858.cd006754.pub4