Cocaine Addiction
Conditions
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.
Interventions
DRUGDexamphetamine
Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed