NCT01486810

Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In an eight-week open label outpatient pilot trial, we will evaluate the safety, tolerability, and potential utility of LDX in the treatment of cocaine dependence. Patients will receive a flexible-fixed dosing schedule under open-label conditions. 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, followed by a two week run-down period. 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. The primary outcome measures will be 1) the maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period 2) lisdexamfetamine tolerability as measured by adverse effects reported on the Systematic Assessment for Treatment and Emergent Events (SAFTEE). Secondary outcome measures will be 1) cocaine use as recorded by the number of days of use on the Timeline Follow-Back method (Sobell \& Sobell, 1992) and confirmed by urine toxicology, 2) cocaine craving as measured by the Cocaine Craving Scale (CCS) and Cocaine Craving Questionnaire (CCQ) and 3) alternate measures of cocaine use, such as the dollar value of cocaine used per day, as measured by the Timeline Follow-Back method, and the proportion of urine toxicology samples negative for cocaine.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine	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
BEHAVIORAL	medication management	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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-12-07
• Last updated: 2019-04-24
• Results posted: 2018-07-11

Locations

1 site across 1 country: United States