Acute physiological and behavioral effects of oral cocaine in humans: a dose-response analysis

The present study was designed to assess the acute physiological and behavi oral effects of a wide range of doses of oral cocaine HCL (placebo, 50, 100 , 200, and 300 mg). Nine volunteers (eight males and one female) with recen t histories of cocaine use resided on a general inpatient psychiatry unit w hile they participated. Drug doses were administered in a double-blind fash ion under medical supervision, but for safety purposes, they were administe red in ascending order. The physiological, subject-rated, and performance e ffects of oral cocaine HCL were assessed before drug administration and per iodically afterwards for 5 h. Oral cocaine HCL increased heart rate and blo od pressure as a graded function of dose, but the magnitude of these effect s were not clinically significant. Oral cocaine HCL produced positive subje ct-rated drug effects (e.g. increased ratings of good effects, like drug, a nd willing to take again), but did not affect performance. Consistent with the pharmacokinetics of oral cocaine HCL, drug effects were generally disce rnible from placebo 0.5-1 h after administration, peaked approximately 1 h after administration, and progressively abated during the remainder of the experimental session. The results of this experiment demonstrate that acros s a six-fold range of doses oral cocaine HCL is well tolerated by individua ls with recent histories of cocaine use and can be safely administered unde r controlled laboratory and medical conditions. (C) 1999 Elsevier Science I reland Ltd. All rights reserved.