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 behavioral 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 recent histories of cocaine use resided on a general inpatient psychiatry unit while they participated. Drug doses were administered in a double-blind fashion under medical supervision, but for safety purposes, they were administered in ascending order. The physiological, subject-rated, and performance effects of oral cocaine HCL were assessed before drug administration and periodically afterwards for 5 h. Oral cocaine HCL increased heart rate and blood pressure as a graded function of dose, but the magnitude of these effects were not clinically significant. Oral cocaine HCL produced positive subject-rated drug effects (e.g. increased ratings of good effects, like drug, and willing to take again), but did not affect performance. Consistent with the pharmacokinetics of oral cocaine HCL, drug effects were generally discernible 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 across a six-fold range of doses oral cocaine HCL is well tolerated by individuals with recent histories of cocaine use and can be safely administered under controlled laboratory and medical conditions.

RCT Entities:   Population Interventions Outcomes