Long acting naltrexone for opioid addiction: the importance of mental, physical and societal factors for sustained abstinence and recovery.

Opioid dependence has a number of negative consequences both for the patient, their relatives and to society. This project is exploring how long term abstinence from opioids influence mental or somatic health or health problems, and how such abstinence can promote a personal recovery process.Further we explore the patients perspective on enablers and barriers to continue over time with such opioid receptor blocking treatment. The study utilize the joint resources of the patients, community-and specialist health service providers, and national registries. Abstinence from opioids is induced using monthly injections of extended-release naltrexone (XR-NTX), a novel treatment for opioid addiction that blocks relevant opioid receptors and thereby prevents intoxication or getting high on opioids. The study is divided into 4 work packages, 1) treatment with long-acting naltrexone (XR-NTX) and the collection of data via questionnaire, 2) qualitative interview with patients and relatives, 3) health Economics and 4) behavioral assessments. The study is detailed planned in a protocol approved by regional committees for medical and Health research ethics, the Norwegian Medicine Agency and Data protection officer at each hospital. Until 1.October 2022, five articles have been published or accepted for publication in peer-reviewed international medical journals. A number of study workers have presented data from the study at international congresses.

-

This proposal aims at exploring how voluntarily XR-NTX induced long term abstinence from opioids may improve mental or somatic health problems and recovery with regard to illicit drug use, work-,school- and housing situation in patients with opioid addiction.The project utilizes the joint resources of patients, community-and specialist health service providers and national registries.The project includes a study of XR-NTX used in a clinical setting - a novel treatment not yet approved in the EU. XR-NTX blocks relevant opioid receptors and thereby prevents intoxication or getting high on opioids. All study procedures will be performed in full accordance with Good Clinical Practice (GCP), including GCP courses for all personnel, independent monitoring of data and a GCP-compliant database with complete entry tracking and data verification. We will investigate the following: a)Possible changes in mental and somatic health symptoms and status, related to the continued XR-NTX induced abstinence from opioids, assessed by health workers. b)Assessment of patients recovery process in the treatment period c) A qualitative study on enablers and barriers to agreeing to, and continuing over time with XR-NTX d) Patients conceptualization of possible changes in mental and somatic health symptoms and status before and after long-term abstinence from opioids. e) Self-reported patient needs, met or unmet,during the recovery process. f) A health economic study comparing registry data on estimated costs of three treatment modalities for opioid addiction: The novel 4-weekly XR-NTX injections, conventional opioid maintenance treatment (LAR /OMT) and no medication treatment. This study proposal applies for funding of 3 PhD candidates and 1 postdoctoral candidate, and will require comprehensive collaboration between community based and hospital addiction services and also involve user representatives / co-researchers.