CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Lisdexamfetamine +1 moredrug
Likely dose
Lisdexamfetamine 140mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01486810
NCT01486810Phase 2Completed
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Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

New York State Psychiatric Institute·interventional·Posted Dec 7, 2011·Updated Apr 24, 2019

In Brief

A Phase 2 clinical trial evaluating Lisdexamfetamine and medication management for Cocaine Dependence. Completed, enrolled 17 participants across 1 site.

Detailed Summary

The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence and to determine an effective dosage range.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 7, 2011
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.6 years ago

Interventions

Lisdexamfetaminedrug

Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks

medication managementbehavioral

All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.