Trial intelligence / Profile preview

Keppra in Cocaine Abusing Methadone-maintained Patients

NCT00593125Phase 2

Key facts

Status: Completed
Start: Jan 2007
Primary completion: Aug 2007
Countries: 1
Sponsor: Yale University
Modality: Small Molecules

Drugs: levetiracetam
Conditions: cocaine dependence

Overview

Phase 2, open-label, single-arm trial of levetiracetam in cocaine dependence, sponsored by Yale University. Primary endpoint: Medication emergent side-effects at 12 weeks. Started Jan 2007; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

levetiracetam
Participants receive levetiracetam up to 3000 mg/day concurrently with methadone maintenance.

Who it enrols

Adults aged 18-65 with concurrent opioid and cocaine dependence, willing to undergo methadone maintenance and use contraception if female. Excludes those with other substance dependencies, serious medical or psychiatric illnesses, or abnormal liver/renal function.

Endpoints

Primary

Medication emergent side-effects12 weeks

Secondary

Thrice weekly urine toxicology12 weeks
Weekly self-report of cocaine and opioid use12 weeks
Weeks in treatment12 weeks
Change in cocaine craving12 weeks
Change in anxiety symptoms12 weeks
Change in opiate withdrawal symptoms12 weeks

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