method development for further drug research method development
Conditions
Interventions
Administration of amphetamine 20 mg (four times)
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age between 25 and 45 (inclusive);Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive);Naïve to drugs containing amphetamine, cocaine or MDMA (ecstacy). This includes medically prescribed amphetamines or methylphenidate. Past (but not current) recreational use of THC, or use of nicotine is allowed.;Signed informed consent prior to any study-mandated procedure.;Ability to communicate well with the investigator in the Dutch language
Exclusion criteria
Exclusion criteria: Clinically significant (history of) disease as determined by medical history, physical examination, ECG or routine blood chemistry, hematology or virology tests;Clinically significant (history of) psychiatric illnesses (including substance abuse) or (history of) psychotic symptoms;Family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree);Smokes more than 10 cigarettes a day and unwilling/unable to refrain from smoking during study occasions;Positive urine drug screen for recreational drugs (i.e. cocaine, opioids, benzodiazepines, amphetamines, metamphetamines, MDMA and/or THC);Blood loss or donation outside the limits of the Dutch blood bank (Sanquin) ;Participation in a clinical study within the past three months, or participation in four or more clinical studies in the past twelve months;Exposure to procedures involving radiation in the year prior to study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventral striatum dopamine release ([11]C raclopride displacement) Saccadic eye movements Smooth pursuit eye movements EEG Adaptive tracking Profile of mood states (POMS) (bipolar) Bond and Lader and Bowdle visual analogue scales Addiction research centre inventory (ARCI) amphetamine Choice Reaction Time Finger tapping Body sway Prolactin, growth hormone and cortisol levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Serum PK profile of amphetamine following oral dose administration Safety: Safety and tolerability, descriptive | — |
Countries
Netherlands
Outcome results
None listed