Back to results

Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Primary Purpose

Cocaine Addiction

Status

Completed

Phase

Early Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

Dexamphetamine

About this trial

This is an interventional treatment trial for Cocaine Addiction

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have completed at least 80% of the previous study (CATCH)
Be able and willing to participate in the study and assessments
Have provided written informed consent.

Exclusion Criteria:

Any intake of dexamphetamine 7 days or less before the start of the proposed study;
Contraindications for dexamphetamine
(desired) pregnancy or continued lactation
Insufficient command of the Dutch language
Current participation in another trial

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Participants receiving Dexamphetamine 60 mg SR

Outcomes

Primary Outcome Measures

Area under the Curve (AUC) of dexamphetamine

Maximum plasma concentration (Cmax) of dexamphetamine

Half life (T 1/2) of dexamphetamine

Secondary Outcome Measures

Full Information

NCT ID

NCT02768441

First Posted

April 26, 2016

Last Updated

June 1, 2017

Sponsor

The Netherlands Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT02768441

Brief Title

Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Official Title

Pharmacokinetics of New Dexamphetamine Sustained Release Tablets and the Clinical Validation of Measuring Dexamphetamine in Dried Blood Spots

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 1, 2016 (Actual)

Primary Completion Date

June 1, 2017 (Actual)

Study Completion Date

June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Netherlands Cancer Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

Participants receiving Dexamphetamine 60 mg SR

Intervention Type

Drug

Intervention Name(s)

Dexamphetamine

Intervention Description

Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days

Primary Outcome Measure Information:

Title

Area under the Curve (AUC) of dexamphetamine

Time Frame

Determined on the 5 day bloodsamples taken

Title

Maximum plasma concentration (Cmax) of dexamphetamine

Time Frame

Determined on the 5 day bloodsamples taken

Title

Half life (T 1/2) of dexamphetamine

Time Frame

Determined on the 5 day bloodsamples taken

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have completed at least 80% of the previous study (CATCH) Be able and willing to participate in the study and assessments Have provided written informed consent. Exclusion Criteria: Any intake of dexamphetamine 7 days or less before the start of the proposed study; Contraindications for dexamphetamine (desired) pregnancy or continued lactation Insufficient command of the Dutch language Current participation in another trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wim van den Brink, PhD

Organizational Affiliation

Academic Psychiatric Center AMC-UvA

Official's Role

Principal Investigator

Facility Information:

Facility Name

AMC

City

Amsterdam

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

We'll reach out to this number within 24 hrs