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Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution

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ClinicalTrials.gov Identifier: NCT00776555
Recruitment Status : Terminated (The study was stopped by the sponsor based on a non-safety related business priority decision.)
First Posted : October 21, 2008
Results First Posted : July 7, 2010
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to compare subjective drug liking using the Drug Rating Questionnaire, subject version (DRQ-S), question 2 and pharmacokinetics of Vyvanse™ and ADDERALL XR® when administered as an oral solution.

Hypothesis: DRQ-S, question 2 will show no difference between the two drugs


Condition or disease Intervention/treatment Phase
Healthy Drug: Lisdexamfetamine Dimesylate Drug: Racemic mixture of dextroamphetamine and lisdexamfetamine Phase 1

Detailed Description:
Not required

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: A Single-Blind, Randomized Study of the Comparative Drug Likeability and Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as a Solution
Study Start Date : November 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vyvanse™
50mg capsule that has been emptied and made into solution
Drug: Lisdexamfetamine Dimesylate
Study is a two-period cross-over design where subjects will have 2 Screening visits, a Baseline visit, and then be enrolled into the study for 2 Periods. Each Period has 2-3 visits and lasts from 2-6 weeks. At each Period visit subjects will be given one of the two treatment arm drugs that have been solubilized and then have blood drawn for pharmacokinetic analysis and the Drug Rating Questionnaire administered. At the end of Period 1 subjects will be crossed-over to the alternative treatment drug for the Period 2. The Vyvanse™ capsule contents will emptied into water to make a solution and given to subjects to drink at the beginning of each Period visit.
Experimental: ADDERALL XR®
20mg capsule that has been emptied, crushed, and made into solution
Drug: Racemic mixture of dextroamphetamine and lisdexamfetamine
Same visits as described for Vyvanse™. The ADDERALL XR® capsule contents will be crushed, solubilized with water, and given to subjects to drink prior to pharmacokinetic blood draws and DRQ-S administration over the course of two periods.


Outcome Measures

Primary Outcome Measures :
  1. Drug Rating Questionnaire-Subject (DRQ-S), Question 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose ]
    Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.


Secondary Outcome Measures :
  1. DRQ-S, Question 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose ]
    Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.

  2. DRQ-S, Question 3 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose ]
    Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Healthy young adults, male or female (non-pregnant and non-lactating), age 18-25 years at time of consent
  • Have a body mass index (BMI) between 20.0 and 29.0kg/m2
  • Satisfactory medical assessment with no clinically significant or relevant
  • Subject must demonstrate a positive response to amphetamine at Screening

Exclusion Criteria

  • A history of current or recurrent disease that could have an effect on the study
  • Subject has a history of seizures, any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder
  • Subject has a concurrent chronic or acute illness or other condition that might confound the results of safety assessments or that might increase risk to the subject
  • Subject has any clinically significant ECG and/or laboratory abnormalities
  • Subject has a documented allergy, hypersensitivity or intolerance to amphetamines
  • Subject has been prescribed or has taken amphetamine products in the past, including childhood; recreational use may not be exclusionary per the Investigator's discretion
  • Subject has a known family history of sudden cardiac death or ventricular arrhythmia
  • Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine)
  • Subject has participated in any investigational clinical or vaccine trial within 30 days prior to the first dose of study drug
  • Subjects is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776555


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Thomas Spencer, M.D. Massachusetts General Hospital
More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00776555     History of Changes
Other Study ID Numbers: SPD489-112
First Posted: October 21, 2008    Key Record Dates
Results First Posted: July 7, 2010
Last Update Posted: March 23, 2015
Last Verified: June 2010

Keywords provided by Shire:
Not required

Additional relevant MeSH terms:
Pharmaceutical Solutions
Lisdexamfetamine Dimesylate
Adderall
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents