Clinical Trials Logo
  1. Home
  2. Cocaine Dependence
  3. NCT01486810

Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence — Vyvance  

Cocaine Dependence Clinical Trial

Official title:
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01486810
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2011
Completion date December 2013
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04994821 - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study Phase 2
Completed NCT01402492 - Cocaine Use Reduction With Buprenorphine Phase 2/Phase 3
Completed NCT01601743 - Exercise as a Behavioral Treatment for Cocaine Dependence N/A
Completed NCT01176591 - HBPL Study of the Impact of the NK1 Antagonist Aprepitant Phase 2
Completed NCT00880997 - The Efficacy of Doxazosin for Cocaine Users Phase 1
Completed NCT00566969 - Cocaine Withdrawal and Pharmacotherapy Response N/A
Completed NCT00585520 - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues Phase 1
Completed NCT00368290 - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior Phase 2
Completed NCT00385801 - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence Phase 2
Completed NCT00322309 - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects Phase 2
Completed NCT00842517 - Long Term Maintenance of Drug Abstinence Phase 1
Completed NCT00167245 - Topiramate for Alcohol and Cocaine Dependence Phase 2
Not yet recruiting NCT05974202 - rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder Phase 2
Completed NCT04411914 - Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid Phase 1
Active, not recruiting NCT03266939 - Rebalancing the Serotonergic System in Cocaine Dependence Phase 1
Completed NCT02563769 - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study Phase 1
Recruiting NCT06159387 - Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts Phase 4
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Completed NCT02018263 - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans Phase 1
Withdrawn NCT01406522 - Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics Phase 2