NCT02768441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Nov 2016

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

April 26, 2016

Last Update Submit

June 1, 2017

Conditions

Cocaine Addiction

Outcome Measures

Primary Outcomes (3)

  • Area under the Curve (AUC) of dexamphetamine

    Determined on the 5 day bloodsamples taken

  • Maximum plasma concentration (Cmax) of dexamphetamine

    Determined on the 5 day bloodsamples taken

  • Half life (T 1/2) of dexamphetamine

    Determined on the 5 day bloodsamples taken

Study Arms (1)

Study group

EXPERIMENTAL

Participants receiving Dexamphetamine 60 mg SR

Drug: Dexamphetamine

Interventions

DexamphetamineDRUG

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

Study group

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMC

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Wim van den Brink, PhD

    Academic Psychiatric Center AMC-UvA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 11, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

NL(1)