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

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lisdexamfetamine
medication management
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine, lisdexamfetamine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • STARS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lisdexamfetamine and medication management

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.
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.
The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2011
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01486810
Brief Title
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Acronym
Vyvance
Official Title
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine, lisdexamfetamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lisdexamfetamine and medication management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine
Other Intervention Name(s)
Vyvance
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
medication management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.
Description
Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..
Time Frame
during 1 week of study participation
Title
Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.
Description
The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.
Time Frame
during 8 weeks of trial or length of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Mariani, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
STARS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

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