Clinical investigation on the development of dependence during oral therapy with tramadol.
In a multicenter study 153 in- and outpatients suffering from severe pain were treated for three weeks with capsules containing 50 mg 1-(m-methoxyphenyl)-2-(dimethylaminomethyl)-cyclohexan-1-ol (tramadol, Tramal). The daily dosage was limited to 400 mg. At the end of the third week the patients received in a randomized double-blind manner 1.6 mg naloxone or saline (both i.m.) to evaluate the risk of developing dependence during the 3-week tramadol treatment (precipitation test). A total of 109 patients completed the trial. Development of tolerance was not observed as was evident from a constant daily tramadol dose associated with constant analgesia. The median net withdrawal scores for the naloxone treated group (mean = 0, Xmin = 0, Xmax = 13) and for the saline treated group (mean = 0, Xmin = 0, Xmax = 5) indicate absence of dependence. The outcome of the study thus suggests that tramadol under the conditions described does not induce dependence.
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000494:pharmacology; D010146:Pain / Q000188:drug therapy*; D011233:Precipitin Tests; D011897:Random Allocation; D013375:Substance Withdrawal Syndrome / Q000139:chemically induced; D019966:Substance-Related Disorders / Q000175:diagnosis / Q000209:etiology*; D014147:Tramadol / Q000009:adverse effects / Q000627:therapeutic use
D003511:Cyclohexanols; D009270:Naloxone; D014147:Tramadol