• J Pharm Sci · May 2004

    Randomized Controlled Trial Comparative Study Clinical Trial

    Development and pharmacokinetic characterization of pulmonal and intravenous delta-9-tetrahydrocannabinol (THC) in humans.

    • Myrtha Naef, Stefan Russmann, Steen Petersen-Felix, and Rudolf Brenneisen.
    • Department of Clinical Research, University of Bern, Murtenstrasse 35, CH-3010 Bern, Switzerland.
    • J Pharm Sci. 2004 May 1;93(5):1176-84.

    AbstractThe aim of the present study was to develop a physiologically compatible inhalation solution of delta-9-tetrahydrocannabinol (THC), and to compare the pharmacokinetic and analgesic properties of pulmonal THC versus pulmonal placebo and intravenous (iv) THC, respectively. Eight healthy volunteers were included in this randomized, double-blind, crossover study. The aqueous THC formulations were prepared by using a solubilization technique. iv THC (0.053 mg/kg body weight), pulmonal THC (0.053 mg/kg), or a placebo inhalation solution was administered as single dose. At defined time points, blood samples were collected, and somatic and psychotropic side effects as well as vital functions monitored. An ice water immersion test was performed to measure analgesia. Using a pressure-driven nebulizer, the pulmonal administration of the THC liquid aerosol resulted in high THC peak plasma levels within minutes. The bioavailability of the pulmonal THC was 28.7 +/- 8.2% (mean +/- SEM). The side effects observed after pulmonal THC were coughing and slight irritation of the upper respiratory tract, very mild psychotropic symptoms, and headache. The side effects after iv THC were much more prominent. Neither pulmonal nor iv THC significantly reduced experimentally induced pain.Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 93:1176-1184, 2004

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