Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence (Vyvance)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01486810
First received: November 30, 2011
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Drug: Lisdexamfetamine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • the maximum total lisdexamfetamine dose achieved [ Time Frame: during 1 week of study participation ] [ Designated as safety issue: Yes ]
    Defined as the highest amount of medication per day maintained for a seven day period during the trial.


Secondary Outcome Measures:
  • Change in Cocaine use [ Time Frame: Baseline compared to 8 weeks of trial or length of study participation ] [ Designated as safety issue: No ]
    Cocaine use as recorded by the number of days of use on the Timeline Follow-Back method and confirmed by urine toxicology results

  • Change in Cocaine craving [ Time Frame: Baseline compared to week 8 or last week of study participation ] [ Designated as safety issue: No ]
    Cocaine craving as measured by the Cocaine Craving Scale (CCS)

  • Change in Cocaine craving [ Time Frame: Baseline compared to week 8 or last week of study participation ] [ Designated as safety issue: No ]
    Cocaine craving as measured by the Cocaine Craving Questionnaire (CCQ)


Estimated Enrollment: 12
Study Start Date: December 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lisdexamfetamine
Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
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
Other Name: Vyvance

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals must be treatment seeking
  • Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence
  • Used cocaine at least four days in the past month
  • Individuals must be in good general health
  • Individuals must be capable of giving informed consent and capable of complying with study procedures
  • Women of child-bearing age must agree to use a method of contraception with proven efficacy, consisting of one of the following: 1) Any form of hormonal contraception; 2) Intra-uterine device; 3) Sterilization; 4) Double-barrier contraception which is a combination of two of the following: condoms, spermicide, diaphragm. Pregnancy tests will be performed monthly and if a woman becomes pregnant, the study medication will be discontinued.

Exclusion Criteria:

  • Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, any psychotic disorder other than transient psychosis due to drug abuse, or current major depressive disorder
  • Individuals with any other current Axis I psychiatric disorder as defined by DSM-IV-TR that in the investigator's judgment are unstable, or would be disrupted by study medication, or are likely to require pharmacotherapy during the study period
  • Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
  • Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
  • Individuals with current suicidal risk
  • Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
  • Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, DBP> 90, or HR > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 1.5x upper limit of normal are acceptable), or uncontrolled diabetes
  • Individuals with a history of seizures, hyperthyroidism and/or glaucoma
  • Individuals with a family history of sudden cardiac death
  • History of allergic reaction to study medication
  • Women who are pregnant or nursing
  • Currently being prescribed psychotropic medication by another physician (other than sleep medication)
  • Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486810

Contacts
Contact: elizabeth Martinez 212 923-3031 martine@nyspi.columbia.edu
Contact: daniel Babb 212-740-3205 brooksd@nyspi.columbia.edu

Locations
United States, New York
STARS Recruiting
New York, New York, United States, 10032
Contact: daniel brooks, ma    212-740-3205    brooksd@nyspi.columbia.edu   
Principal Investigator: john mariani, md         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: John Mariani, M.D. Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01486810     History of Changes
Other Study ID Numbers: #6154, P50DA009236-18
Study First Received: November 30, 2011
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
cocaine
lisdexamfetamine

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Dextroamphetamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on August 19, 2014