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

Drug Alcohol Depend. 2000 Jul 1;60(1):39-50. doi: 10.1016/s0376-8716(99)00140-4.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Behavior, Addictive / drug therapy*
  • Behavior, Addictive / psychology
  • Buprenorphine / therapeutic use*
  • Buprenorphine / urine
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Methadone / therapeutic use*
  • Methadone / urine
  • Multivariate Analysis
  • Narcotics / therapeutic use*
  • Narcotics / urine
  • Opioid-Related Disorders / drug therapy*
  • Opioid-Related Disorders / rehabilitation
  • Tablets


  • Narcotics
  • Tablets
  • Buprenorphine
  • Methadone