title: Buprenorphine: a controlled clinical trial in the treatment of opioid dependence.
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.
authors.affiliation: Servizio Tossicodipendenze Azienda USL 8, Cagliari, Italy. pallolo@tin.it
authors.forename: P P
authors.initials: PP
authors.lastname: Pani
authors.forename: I
authors.initials: I
authors.lastname: Maremmani
authors.forename: R
authors.initials: R
authors.lastname: Pirastu
authors.forename: A
authors.initials: A
authors.lastname: Tagliamonte
authors.forename: G L
authors.initials: GL
authors.lastname: Gessa
mesh_terms: D000293:Adolescent; D000328:Adult; D016739:Behavior, Addictive / Q000188:drug therapy* / Q000523:psychology; D002047:Buprenorphine / Q000627:therapeutic use* / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008691:Methadone / Q000627:therapeutic use* / Q000652:urine; D015999:Multivariate Analysis; D009294:Narcotics / Q000627:therapeutic use* / Q000652:urine; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000534:rehabilitation; D013607:Tablets
chemical_list: D009294:Narcotics; D013607:Tablets; D002047:Buprenorphine; D008691:Methadone