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Clinical Experience with Fortnightly Buprenorphine/Naloxone versus Buprenorphine in Italy

Preliminary Observational Data in an Office-Based Setting

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Abstract

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.

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Acknowledgements

Funding for this study was provided by Ser.T, Cava dei Tirreni ASL, Salerno and no external funds were provided in design and conduct of study, the collection, the management, analysis or interpretation of data and preparation, review and approval of the manuscript. English language assistance and medical writing expertise for the preparation of this manuscript were provided by Nicola Ryan of inScience Communications. This assistance was funded by Schering Plough, Essex Italy.

Dr Amato thanks the following professionals: Nurses: C. Croce, L. D’Acunzi, R. Ferrara, S. Palumbo, Psychologists: A. Napoletano, L. Pagano, L. Cutolo, Social Worker: M.R. Sorrentino, Director Sert Cava dei Tirreni: C. Armenante for their assistance with data collection and administering psychological tests. Dr Amato declares no conflicts of interest.

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  1. Ser.T, Cava dei Tirreni ASL, Salerno, Italy

    Patrizia Amato

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Amato, P. Clinical Experience with Fortnightly Buprenorphine/Naloxone versus Buprenorphine in Italy. Clin. Drug Investig. 30 (Suppl 1), 33–39 (2010). https://doi.org/10.2165/11536060-000000000-00000

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