An integrated approach for the evaluation of psychotropic drug in man. I. Studies on amphetamine. Relationship between drug levels and psychophysiological measurements.

Following an integrated approach based on the contemporary recording of drug plasma levels, central (CNS) and peripheral responses and performance tests, the effects of two different amphetamine formulations were evaluated in healthy volunteers. Interesting relationships were observed between amphetamine initial rate of entry into the blood stream and both incidence of side effects (S.E.) and rise in arterial blood pressure. Minimal thresholds for CNS (5 ng/ml) and peripheral (20 ng/ml) effects could also be determined. It appeared also that the personality of the subject may have some bearing on both incidence of side effects and performance. The described methodology seems valuable in valuating psychotropic drug effects in man through a comprehensive integrated approach.

RCT Entities:   Population Interventions Outcomes