Evaluation of heroin-assisted treatment in Norway: protocol for a mixed methods study.

BACKGROUND: Opioid agonist treatment (OAT) for patients with opioid use disorder (OUD) has a convincing evidence base, although variable retention rates suggest that it may not be beneficial for all. One of the options to include more patients is the introduction of heroin-assisted treatment (HAT), which involves the prescribing of pharmaceutical heroin in a clinical supervised setting. Clinical trials suggest that HAT positively affects illicit drug use, criminal behavior, quality of life, and health. The results are less clear for longer-term outcomes such as mortality, level of function and social integration. This protocol describes a longitudinal evaluation of the introduction of HAT into the OAT services in Norway over a 5-year period. The main aim of the project is to study the individual, organizational and societal effects of implementing HAT in the specialized healthcare services for OUD. METHODS: The project adopts a multidisciplinary approach, where the primary cohort for analysis will consist of approximately 250 patients in Norway, observed during the period of 2022-2026. Cohorts for comparative analysis will include all HAT-patients in Denmark from 2010 to 2022 (N = 500) and all Norwegian patients in conventional OAT (N = 8300). Data comes from individual in-depth and semi-structured interviews, self-report questionnaires, clinical records, and national registries, collected at several time points throughout patients' courses of treatment. Qualitative analyses will use a flexible inductive thematic approach. Quantitative analyses will employ a wide array of methods including bi-variate parametric and non-parametric tests, and various forms of multivariate modeling. DISCUSSION: The project's primary strength lies in its comprehensive and longitudinal approach. It has the potential to reveal new insights on whether pharmaceutical heroin should be an integral part of integrated conventional OAT services to individually tailor treatments for patients with OUD. This could affect considerations about drug treatment even beyond HAT-specific topics, where an expanded understanding of why some do not succeed with conventional OAT will strengthen the knowledge base for drug treatment in general. Results will be disseminated to the scientific community, clinicians, and policy makers. TRIAL REGISTRATION: The study was approved by the Norwegian Regional Committee for Medical and Health Research Ethics (REK), ref.nr.:195733.

Patients' satisfaction with heroin-assisted treatment: a qualitative study.

BACKGROUND: Heroin-assisted treatment (HAT) involves supervised dispensing of medical heroin (diacetylmorphine) for people with opioid use disorder. Clinical evidence has demonstrated the effectiveness of HAT, but little is known about the self-reported satisfaction among the patients who receive this treatment. This study presents the first empirical findings about the patients' experiences of, and satisfaction with, HAT in the Norwegian context. METHODS: Qualitative in-depth interviews with 26 patients in HAT were carried out one to two months after their enrollment. Analysis sought to identify the main benefits and challenges that the research participants experienced with this treatment. An inductive thematic analysis was conducted to identify the main areas of benefits and challenges. The benefits were weighed against the challenges in order to assess the participants' overall level of treatment satisfaction. RESULTS: Analysis identified three different areas of experienced benefits and three areas of challenges of being in this treatment. It outlines how the participants' everyday lives are impacted by being in the treatment and how this, respectively, results from the treatment's medical, relational, or configurational dimensions. We found an overall high level of treatment satisfaction among the participants. The identification of experienced challenges reveals factors that reduce satisfaction and thus may hinder treatment retention and positive treatment outcomes. CONCLUSIONS: The study demonstrates a novel approach to qualitatively investigate patients' treatment satisfaction across different treatment dimensions. The findings have implications for clinical practice by pointing out key factors that inhibit and facilitate patients' satisfaction with HAT. The identified importance of the socio-environmental factors and relational aspect of the treatment has further implications for the provision of opioid agonist treatment in general.