Three cases of illness during a drug trial in healthy volunteers

Abstract

At the invitation of a drug company we undertook a trial to investigate the effect of an orally administered respiratory stimulant on respiratory depression caused by parenteral morphine in healthy volunteers. The drug has long been used safely intravenously, and tablets are already marketed in France. The ethical committee approved the trial, with the drug company accepting full liability. Twelve paid volunteers consented to enter the trial. Satisfactory health was determined by history, examination, and blood profiles. Each volunteer attended four times to receive the trial drug or placebo, and morphine 0.12 mg/kg or placebo, in double blind and fully randomised fashion. Sedation, ventilation, pain threshold, and plasma drug concentrations were then assessed for eight hours. The trial proceeded uneventfully for five weeks, and seven volunteers began treatment. © 1987, British Medical Journal Publishing Group. All rights reserved.