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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Racemic mixture of dextroamphetamine and lisdexamfetamine; Drug: Lisdexamfetamine Dimesylate

• Registration Number: NCT00776555
• Lead Sponsor: Shire

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

Detailed Description

Not required

Study Timeline

• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Study Start: 2008-11-21
• Primary Completion: 2009-03-31
• Study Completion: 2009-03-31
• Results First Submitted: 2010-05-05
• Results First Submitted QC: 2010-06-04
• Results First Posted: 2010-07-07
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ADDERALL XR®	Racemic mixture of dextroamphetamine and lisdexamfetamine	20mg capsule that has been emptied, crushed, and made into solution
Vyvanse™	Lisdexamfetamine Dimesylate	50mg capsule that has been emptied and made into solution

Primary Outcome Measures

Name	Time	Method
Drug Rating Questionnaire-Subject (DRQ-S), Question 2	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

Name	Time	Method
DRQ-S, Question 3	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.
DRQ-S, Question 1	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States