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Characterizing the subjective, psychomotor, and physiological effects of a hydrocodone combination product (Hycodan) in non-drug-abusing volunteers.

Author(s): Zacny JP

Affiliation(s): Department of Anesthesia and Critical Care/MC4028, Pritzker School of Medicine, University of Chicago, 5841 South Maryland Avenue, Chicago, IL 60637, USA. jzacny@airway.uchicago.edu

Publication date & source: 2003-01, Psychopharmacology (Berl)., 165(2):146-56. Epub 2002 Oct 29.

Publication type: Clinical Trial; Randomized Controlled Trial

RATIONALE: The subjective, psychomotor, and physiological effects of prescription compounds containing the opioid hydrocodone have not been studied in a population of non-drug-abusing people who might be prescribed these compounds for cough or pain relief. OBJECTIVES: To characterize the effects of a hydrocodone combination product, Hycodan, which contains hydrocodone and a peripherally-acting anticholinergic, homatropine, in non-drug-abusing volunteers. METHODS: Eighteen volunteers participated in a crossover, double-blind study in which they received placebo; 5 mg hydrocodone/1.5 mg homatropine, 10 mg hydrocodone/3 mg homatropine, 20 mg hydrocodone/6 mg homatropine (all PO); 40 mg morphine (PO); and 2 mg lorazepam (PO). Measures were assessed before and for 300 min after drug administration. End-of-session and 24-h measures were taken to assess residual drug effects and overall subjects' assessment of the drug effects. RESULTS. Subjective effects of the hydrocodone/homatropine combination were dose-related, although the majority of statistically significant effects were limited to the highest dose combination tested. A combination of 20 mg hydrocodone/6 mg homatropine and morphine had a similar profile of subjective effects, which included both pleasant and unpleasant effects. Peak liking ratings were increased by 20 mg hydrocodone/6 mg homatropine and morphine, and trough ratings of liking (dislike) were lower in the 20 mg hydrocodone/6 mg homatropine condition, relative to the placebo condition. Post-session ratings of overall liking were not significant, either at the end of the session or 24 h later. Cognitive and psychomotor impairment were more marked with lorazepam than with hydrocodone/homatropine and morphine. Miosis and exophoria were increased in a dose-related manner by hydrocodone/homatropine. CONCLUSIONS: Hycodan at the highest dose tested had effects similar to that of a prototypic mu agonist, morphine. Both drugs produced pleasant (including drug liking) as well as unpleasant subjective effects. Post-session ratings of overall liking and "want to take drug again" were not significant.

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