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

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ClinicalTrials.gov Identifier: NCT01486810
Recruitment Status : Completed
First Posted : December 7, 2011
Results First Posted : July 11, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE November 30, 2011
First Posted Date  ICMJE December 7, 2011
Results First Submitted Date  ICMJE June 8, 2018
Results First Posted Date  ICMJE July 11, 2018
Last Update Posted Date April 24, 2019
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose. [ Time Frame: during 1 week of study participation ]
    Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..
  • Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial. [ Time Frame: during 8 weeks of trial or length of participation ]
    The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
the Maximum Total Lisdexamfetamine Dose Achieved [ Time Frame: during 1 week of study participation ]
Defined as the highest amount of medication per day maintained for a seven day period during the trial.
Change History Complete list of historical versions of study NCT01486810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
  • Change in Cocaine use [ Time Frame: Baseline compared to 8 weeks of trial or length of study participation ]
    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 ]
    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 ]
    Cocaine craving as measured by the Cocaine Craving Questionnaire (CCQ)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Official Title  ICMJE Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE Experimental: Lisdexamfetamine and medication management
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. 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.
Interventions:
  • Drug: Lisdexamfetamine
  • Behavioral: medication management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2016)
17
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2011)
12
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01486810
Other Study ID Numbers  ICMJE #6154
P50DA009236-18 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John Mariani MD, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: John Mariani, M.D. Columbia University
PRS Account New York State Psychiatric Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP