Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cocaine Addiction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Participants receiving Dexamphetamine 60 mg SR

Group Type EXPERIMENTAL

Dexamphetamine

Intervention Type DRUG

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

Interventions

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Dexamphetamine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No