Clinical Drug Investigation

, Volume 30, Supplement 1, pp 33–39

Clinical Experience with Fortnightly Buprenorphine/Naloxone versus Buprenorphine in Italy

Preliminary Observational Data in an Office-Based Setting
Original Research Article


Background and objective: Buprenorphine/naloxone is a new option for the management of opioid dependence. It has a reduced potential for abuse or misuse compared with methadone and buprenorphine alone, and has a long half-life allowing less frequent dosing. Buprenorphine/naloxone appears to be well suited for the management of opioid dependence in an office-based setting. The aim of this study was to evaluate the efficacy and safety of a buprenorphine/naloxone combination treatment in an office-based setting. Therefore, we evaluated the effect on misuse/diversion, quality of care, quality of life and service delivery.

Study design: Seventy-eight patients were switched to buprenorphine/naloxone from either methadone or buprenorphine alone; the median duration of previous buprenorphine or methadone treatment was 10 years. Patients received buprenorphine/naloxone and were evaluated throughout a 1-year follow-up period. Treatment was self-administered by the patients every 2 weeks and the mean buprenorphine dosage at 1 year was 8 mg/day. Comparisons were made before and after the switch for patients who switched from buprenorphine alone to buprenorphine/naloxone.

Results: Switching to buprenorphine/naloxone was not associated with clinically relevant problems in 50% of patients studied. Buprenorphine/naloxone provided satisfactory coverage of withdrawal symptoms in 78.1% of patients, and 50% of patients were satisfied with buprenorphine/naloxone therapy. Seventy-eight per cent of patients reported improved psychosocial functioning. The majority of patients (approximately 85%) were negative for opioids during toxicological testing. A significantly higher proportion of treatment recipients were highly satisfied during buprenorphine/naloxone administration (p< 0.001 compared with buprenorphine given before the switch). Other outcomes were similar during buprenorphine and buprenorphine/naloxone administration. Fortnightly self-administration of buprenorphine/naloxone appeared to be cost saving for the clinic.

Conclusion: Buprenorphine/naloxone is an effective and safe treatment option for the outpatient management of opioid dependence.


  1. 1.
    Bickel WK, Stitzer ML, Bigelow GE, et al. Buprenorphine: dose-related blockade of opioid challenge effects in opioid dependent humans. J Pharmacol Exp Ther 1988 Oct; 247(1): 47–53PubMedGoogle Scholar
  2. 2.
    Johnson RE, Strain EC, Amass L. Buprenorphine: how to use it right. Drug Alcohol Depend 2003 May 21; 70(2 Suppl.): S59–77PubMedCrossRefGoogle Scholar
  3. 3.
    Prescribing Information — Methadone (Italy). [cited 2009 14 Nov]; Available from: cont/020ser/050pro/default.asp?method=Mostra_Contenuto &id_cont=61641Google Scholar
  4. 4.
    Wedam EF, Bigelow GE, Johnson RE, et al. QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial. Arch Intern Med 2007 Dec 10; 167(22): 2469–75PubMedCrossRefGoogle Scholar
  5. 5.
    Alho H, Sinclair D, Vuori E, et al. Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. Drug Alcohol Depend 2007 Apr 17; 88(1): 75–8PubMedCrossRefGoogle Scholar
  6. 6.
    Best SE, Oliveto AH, Kosten TR. Opioid addiction: recent advances in detoxification and maintenance therapy. CNS Drugs 1996; 6(4): 301–14CrossRefGoogle Scholar
  7. 7.
    Chapleo CB, Walter DS. The buprenorphine-naloxone combination product. Res Clin Forums 1997; 19(2): 55–8Google Scholar
  8. 8.
    Robinson SE. Buprenorphine-containing treatments: place in the management of opioid addiction. CNS Drugs 2006; 20(9): 697–712PubMedCrossRefGoogle Scholar
  9. 9.
    Fudala PJ, Bridge TP, Herbert S, et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med 2003 Sep 4; 349(10): 949–58PubMedCrossRefGoogle Scholar
  10. 10.
    Drug Addiction Treatment Act. 42 U§Cy3502a; 2000Google Scholar
  11. 11.
    Amass L, Ling W, Freese TE, et al. Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. Am J Addict 2004; 13(Suppl. 1): S42–66PubMedCrossRefGoogle Scholar
  12. 12.
    Gunderson EW, Fiellin DA. Office-based maintenance treatment of opioid dependence: how does it compare with traditional approaches? CNS Drugs 2008; 22(2): 99–111PubMedCrossRefGoogle Scholar
  13. 13.
    Helm S, Trescot AM, Colson J, et al. Opioid antagonists, partial agonists, and agonists/antagonists: the role of office-based detoxification. Pain Physician 2008 Mar–Apr; 11(2): 225–35PubMedGoogle Scholar
  14. 14.
    Bridge TP, Fudala PJ, Herbert S, et al. Safety and health policy considerations related to the use of buprenorphine/ naloxone as an office-based treatment for opiate dependence. Drug Alcohol Depend 2003 May 21; 70(2 Suppl.): S79–85PubMedCrossRefGoogle Scholar
  15. 15.
    Zung WWK. A rating instrument for anxiety disorders. Psychosomatics 1971; 12: 371–9PubMedGoogle Scholar
  16. 16.
    Zung WWK. A self-rating depression scale. Arch Gen Psychiatry 1965; 12: 63–70PubMedCrossRefGoogle Scholar
  17. 17.
    Simojoki K, Vorma H, Alho H. A retrospective evaluation of patients switched from buprenorphine (Subutex) to the buprenorphine/naloxone combination (Suboxone). Subst Abuse Treat Prev Policy 2008; 3: 16PubMedCrossRefGoogle Scholar
  18. 18.
    Fiellin DA, Pantalon MV, Pakes JP, et al. Treatment of heroin dependence with buprenorphine in primary care. Am J Drug Alcohol Abuse 2002; 28(2): 231–41PubMedCrossRefGoogle Scholar
  19. 19.
    Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med 2006 Jul 27; 355(4): 365–74PubMedCrossRefGoogle Scholar
  20. 20.
    O’Connor PG, Oliveto AH, Shi JM, et al. A pilot study of primary-care-based buprenorphine maintenance for heroin dependence. Am J Drug Alcohol Abuse 1996 Nov; 22(4): 523–31PubMedCrossRefGoogle Scholar
  21. 21.
    Resnick RB, Galanter M, Resnick E, et al. Buprenorphine treatment of heroin dependence (detoxification and maintenance) in a private practice setting. J Addict Dis 2001; 20(2): 75–83PubMedCrossRefGoogle Scholar
  22. 22.
    Stein MD, Cioe P, Friedmann PD. Buprenorphine retention in primary care. J Gen Intern Med 2005 Nov; 20(11): 1038–41PubMedCrossRefGoogle Scholar
  23. 23.
    Bell J, Byron G, Gibson A, et al. A pilot study of buprenorphine-naloxone combination tablet (Suboxone) in treatment of opioid dependence. Drug Alcohol Rev 2004 Sep; 23(3): 311–17PubMedCrossRefGoogle Scholar
  24. 24.
    O’Connor PG, Oliveto AH, Shi JM, et al. A randomized trial of buprenorphine maintenance for heroin dependence in a primary care clinic for substance users versus a methadone clinic. Am J Med 1998 Aug; 105(2): 100–5PubMedCrossRefGoogle Scholar
  25. 25.
    Ortner R, Jagsch R, Schindler SD, et al. Buprenorphine maintenance: office-based treatment with addiction clinic support. Eur Addict Res 2004; 10(3): 105–11PubMedCrossRefGoogle Scholar
  26. 26.
    Bell J, Shanahan M, Mutch C, et al. A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence. Addiction 2007 Dec; 102(12): 1899–907PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2010

Authors and Affiliations

  1. 1.Ser.T, Cava dei Tirreni ASLSalernoItaly

Personalised recommendations