A 4-period study to investigate the effects of d-amphetamine on psychomotor function in relation to dopamine release capacity in healthy male subjects

Completed

Conditions: method development for further drug research
method development

Registration Number: NL-OMON38881

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ventral striatum dopamine release ([11]C raclopride displacement)<br /><br><br /><br>Saccadic eye movements<br /><br><br /><br>Smooth pursuit eye movements<br /><br><br /><br>EEG<br /><br><br /><br>Adaptive tracking<br /><br><br /><br>Profile of mood states (POMS) (bipolar)<br /><br><br /><br>Bond and Lader and Bowdle visual analogue scales<br /><br><br /><br>Addiction research centre inventory (ARCI) amphetamine<br /><br><br /><br>Choice Reaction Time<br /><br><br /><br>Finger tapping<br /><br><br /><br>Body sway<br /><br><br /><br>Prolactin, growth hormone and cortisol levels</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics:<br /><br>Serum PK profile of amphetamine following oral dose administration<br /><br><br /><br>Safety:<br /><br>Safety and tolerability, descriptive</p><br>