Clinical Drug Investigation

, Volume 30, Supplement 1, pp 21–26

Safety and Efficacy of Buprenorphine/Naloxone in Opioid-Dependent Patients

An Italian Observational Study
  • Fernanda Magnelli
  • Lorita Biondi
  • Roberto Calabria
  • Angelo Fiore
  • Eugenio Peluso
  • Domenico Vonella
  • Amerigo Giuseppe Rota
Original Research Article


Background: Opioid dependence is a growing problem. Methadone is an established agent for the treatment of opioid dependence, but there is a risk of this agent being abused, a potential for interaction with antiretroviral agents and a risk of cardiac toxicity. Another option is the partial μ-opioid receptor opioid agonist buprenorphine, which has been used successfully to manage opioid dependence. While the risk of abuse is lower than that for methadone, there is still a risk. The sublingual combination formulation of buprenorphine and the opioid receptor antagonist naloxone (buprenorphine/naxolone) is a newer agent with reduced abuse potential, and has been shown to have promising efficacy for opioid dependence.

Objectives: We describe the results of an observational study investigating the safety and efficacy of buprenorphine/naloxone in opioid-dependent patients.

Methods: A total of 77 patients were included and were switched from buprenorphine to sublingual tables of buprenorphine/naloxone; the buprenorphine dosage was titrated to achieve good control of withdrawal symptoms. The prevalence of withdrawal symptoms, craving, constipation, cramps, insomnia, sexual activity, depression, sweating, distress, bone/joint pain and drowsiness were compared over the first 30 days of treatment (period 1) and the total 120-day study duration (period 2).

Results: The average buprenorphine/naloxone dose in period 1 was 7.3 mg/day and 12.7 mg/day in period 2. Most patients did not experience any withdrawal symptoms in either period 1 or period 2. Fewer than 20% of patients experienced any cravings over the 120-day study period. Importantly, the adverse effects observed were usually mild, with very few patients experiencing significant adverse effects.

Conclusions: This study shows that buprenorphine/naloxone is an effective and well tolerated treatment for opioid withdrawal when the dosage is titrated to achieve good control of withdrawal symptoms. Switching from buprenorphine alone to buprenorphine/naloxone was possible with very little discomfort for the patient and effective retained patients in treatment.


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Copyright information

© Adis Data Information BV 2010

Authors and Affiliations

  • Fernanda Magnelli
    • 1
  • Lorita Biondi
    • 1
  • Roberto Calabria
    • 1
  • Angelo Fiore
    • 1
  • Eugenio Peluso
    • 1
  • Domenico Vonella
    • 1
  • Amerigo Giuseppe Rota
    • 1
  1. 1.U.O.C Ser.T Cosenza Provincial Health AgencyCosenzaItaly

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