Buprenorphine: a controlled clinical trial in the treatment of opioid dependence☆

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Abstract

Clinical trials carried out to compare methadone and buprenorphine in the treatment of opioid dependence have generally employed an alcoholic solution of buprenorphine, which has a bioavailability superior to that of the tablets. Since the product available for large scale use is in tablet form, one intended to verify the efficacy of this formulation. In a multicentre randomised controlled double blind study, 72 opioid dependent patients were assigned to treatment with buprenorphine (8 mg/day) or methadone (60 mg/day) for a period of 6 months. The two compounds did not show any significant difference with regard to urinalyses: the average percentage of analyses proving negative was 60.4% for patients assigned to buprenorphine, and 65.5% for those assigned to methadone. With regard to retention, a non-significant trend in favour of methadone was observed. Patients completing the trial improved significantly in terms of psychosocial adjustment and global functioning, as ascertained by the DSM-IV-GAF and symptom checklist-90 (SCL-90) scales, and this was independent of the treatment group. Finally, in the case of buprenorphine, patients who dropped out differed significantly from those who stayed, in terms of a higher level of psychopathological symptoms, and a lower level of psychosocial functioning. The results of the study further support the utility of buprenorphine for the treatment of opioid dependence.

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    ☆

    Multicentric coordinators: Mauro Cibin, Nicola Gentile (SER.T. Dolo-VE); Maura Tedici, Lucia Carlomagno (SER.T. Empoli-FI); Fernando Fantini (SER.T. Lanciano-CH); Edoardo Polidori (SER.T. Faenza-RA); Augusto Magnone, Roberto Mollica (SER.T. Milano); Giuliano Villani, Tommaso Vannucchi (SER.T. Prato); Carmelo Siragusa (SER.T. Caserta).

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