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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

XR-Naltrexone for opioid addiction: the importance of mental, physical and societal factors for longer term and post treatment recovery

Alternative title: Langtidsvirkende naltrekson i behandling av opioid avhengighet: betydningen av psykososiale faktorer for langtids rusfrihet og recovery.

Awarded: NOK 7.0 mill.

Opioid addiction has several negative consequences, including the risk of overdose deaths, for the users, their families and the society. Treatment is the most effective factor to prevent such negative consequences and to promote recovery processes. Opioid users are a heterogeneous group and the treatment alternatives necessary to facilitate recovery should thus be individually adapted. Long-acting naltrexone (XR-NTX) is a novel treatment for opioid dependence that blocks the euphoric effects of heroin and other opioids and prevents opioid overdoses. Unlike treatment with methadone or buprenorphine used in Opioid Maintenance Treatment, XR-NTX assists the patients in long-term abstinent from opioids. The ongoing NaltRec study explores various experiences and effects of treatment with XR-NTX among opioid dependent individuals, but the main focus is the patients? recovery processes. Besides examining the safety and efficacy of XR-NTX treatment, the study will explore personal and psychological hindrances and enablers for obtaining recovery from opioid addiction with XR-NTX. Further the study will explore post-treatment effects concerning the degree of sustained abstinence and successful recovery after the XR-NTX treatment period, and thus provide a basis for clinical recommendation of treatment duration. The planned extension of the treatment period together with the 12 months post-treatment follow-up period will also provide a basis for a cost- effectiveness analysis of longer term XR-NTX treatment. Both a longer term treatment length and the post-treatment follow-up part of the study will provide new important knowledge on treatment of opioid addiction.

This proposal for an extension of the ongoing NaltRec study will enable us to explore the degree of sustained abstinence and recovery among opioid dependent individuals also after longer term (up to 12 months) XR-NTX treatment. By individually adapted treatment duration, we will be able to investigate how the length of treatment will influence treatment outcomes and propose a treatment period sufficient to enable a recovery process. The study will also identify patient characteristics (matching factors) that may predict individual lengths of treatment necessary for post treatment effectiveness. Identifying these factors may provide a more robust foundation for clinical recommendation of XR-NTX treatment duration. We will further explore possible differences between shorter- and longer term treatment effectiveness with regard to the status 3, 6 and 12 months post treatment. This will include recovery process, degree of post treatment waning and cost effectiveness. Further we will focus on facilitators and hindrances for staying in longer term treatment and post treatment recovery. This is the first study in Europe on individual recovery in patients receiving longer term treatment with XR-NTX and during 12 months post treatment follow-up in a naturalistic clinical setting. This is also the longest follow-up treatment study performed on treatment with XR-NTX. We do not expect all patients to be in need of 12 months treatment, and we assume that a number of patients will be comfortable with a shorter duration of treatment (6-9 months). This makes it possible to study the individual need for XR-NTX treatment with regard to longer term and post treatment abstinence and recovery. This will further allow a first step towards defining a recommendation for duration of treatment with XR-NTX and also to propose individual needs in treatment length and recovery support. Today there is no recommendation available for the duration of XR-NTX treatment.

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering