Francesca Melis

• Melis, Francesca; Castel, Charlotte Jocelyne Yvonne; Eide, Desiree & Clausen, Thomas (2025). Health-related quality of life trajectories of patients in heroin-assisted treatment. Drug and Alcohol Dependence. ISSN 0376-8716. 275. doi: 10.1016/j.drugalcdep.2025.112839. Full text in Research Archive Show summary

  Background This study investigates health-related quality of life (HRQoL) in individuals with opioid use disorder enrolled in heroin-assisted treatment (HAT). While HRQoL in opioid maintenance treatment has been studied, less is known while in HAT. This study aim is to describe HRQoL in HAT, identify different HRQoL trajectories, and examine factors associated with class memberships. Methods This longitudinal cohort study is based on the multi-center Norwegian HAT project. The sample includes all consenting individuals enrolled in treatment from January 2022 to October 2024 (n = 108). HRQoL was assessed using the EuroQol EQ-5D-5L, and demographics were collected at baseline and multiple time points. Latent class linear mixed models were employed to identify HRQoL trajectory classes and explore differences in class memberships. Results At admission, participants demonstrated significant HRQoL difficulties across all dimensions, with severity levels higher than those of the general Norwegian population, particularly in Pain/Discomfort and Anxiety/Depression. Latent class analysis identified three distinct groups: the largest group (82 %) had a stable HRQoL trajectory, while smaller groups (8 % and 10 %) showed decline and improvement, respectively. Social support, clinic location, parental origin and at least one chronic symptoms were significant predictors of class membership. Conclusion The diverse, lower HRQoL profiles emphasize the need for personalized healthcare and support, making the HAT setting potentially valuable for such tailored care. Treatment participation helps most maintain fairly high HRQoL. The findings confirm the critical role of supportive relationships and effective chronic condition management in HRQoL outcomes.

• Myklebust, Lars Henrik; Eide, Desiree; Wüsthoff, Linda Elise Couessurel; Melis, Francesca; Oldervoll, Ann & Pirro, Silvana De [Show all 7 contributors for this article] (2025). Changes in self-reported mental health, anxiety and depression among patients in heroin-assisted treatment: Findings from a Norwegian trial project. European Addiction Research. ISSN 1022-6877. 31, p. 286–296. doi: 10.1159/000547375. Full text in Research Archive Show summary

  Introduction: Norway’s heroin-assisted treatment (HAT) project started in 2022, aimed at targeting individuals with severe opioid use disorder (OUD) who did not benefit from first-line, conventional opioid agonist treatment. The use of pharmaceutical diacetylmorphine in HAT may particularly benefit patients with comorbid psychiatric disorders due to its structured nature, which includes daily contact with outpatient clinics. However, previous findings on mental health outcomes in HAT have been inconclusive. The main aim of this study was to explore changes in patients’ self-rated mental health and anxiety and depression over the first 12 months of HAT in Norway. Methods: We used data from 2 questions about patients’ self-rated mental health and anxiety and depression collected from 79 patients at the start of treatment (baseline) and at 3, 6, and 12 months into treatment. Ordinal logistic regression models were used to examine the changes in the responses over the observational period and to explore the potential effects of predictors such as gender and age, self-reported substance use, and clinic site. Results: We found a gradual improvement in self-rated mental health from baseline over the observational period, with a statistically significant shift in response distribution at the 12-month mark (p = 0.017). The distribution of responses indicating “good” mental health increased with a 35% improvement at 12 months, with a corresponding decline of 48% in “bad” mental health. For self-rated anxiety and depression, we found no change in severity of self-rated symptoms. A decline of 48% in the proportion of responses reporting severe symptoms at 12 months was aligned with a simultaneous increase of 17% reporting moderate symptoms. Age and previous suicide attempts were significant predictors of both outcomes; gender influenced anxiety and depression only, whereas clinic site influenced only mental health ratings. Conclusion: HAT appears to gradually improve patients’ self-rated mental health over time, possibly by enhancing overall psychological well-being. Self-rated symptoms of anxiety and depression may not be affected by this treatment, indicating that psychiatric conditions can persist in HAT for those struggling with them. This highlights the importance of specific psychiatric assessments and targeted interventions for at least a subset of patients, underscoring the need for integrated treatment approaches within HAT programs that address both substance use and co-occurring psychiatric disorders.

• Melis, Francesca; Kvamme, Timo L.; Tjagvad, Christian; Eide, Desiree; Thylstrup, Birgitte & Clausen, Thomas [Show all 7 contributors for this article] (2025). Health-related quality of life measures as predictors for recurrent hospitalization and mortality among patients in heroin-assisted treatment. Quality of Life Research. ISSN 0962-9343. 34, p. 3365–3376. doi: 10.1007/s11136-025-04019-5. Full text in Research Archive Show summary

  Purpose Individuals with opioid use disorder face complex health needs often necessitating hospital-based care, and many reported low health-related quality of life (HRQoL). This study assessed HRQoL factors as predictors of recurrent hospital-based care and mortality among heroin-assisted treatment (HAT) patients, identified patient groups with distinct HRQoL trajectories, and compared their hospital contact hours and mortality rates with the general population. Methods A longitudinal cohort study was conducted, involving 541 HAT patients in Denmark from 2010 to 2018, along with a matched sample from the general Danish population. Using recurrent event regression and latent class growth analysis, we analyzed predictors of recurrent hospitalization and established trajectory groups. HRQoL was assessed using the 36-Item Short Form Health Survey (SF-36) and linked to multiple national registry data which provided demographic variables, hospital utilization, and mortality data. Results “General health” emerged as the largest and only significant predictor of recurrent hospitalization. Mortality was predicted by age and ‘role limitations due to emotional problems’. We identified four trajectory groups based on “general health ”, showing either a decreasing or stable trajectory. Groups differed significantly in terms of average hospital contact hours and mortality and all groups had lower ‘general health’ scores and greater mortality than the representative Danish sample. The most severe group had four times higher usage of hospitalization hours. Conclusion SF-36 ‘general health’ is a key risk stratification tool for HAT patients predicting outcomes like hospitalization and mortality. Identifying high-risk individuals can help clinicians implement timely (somatic) care, particularly for long-term patients.

• Melis, Francesca; Clausen, Thomas; Castel, Charlotte Jocelyne Yvonne; Dadras, Omid; Pirro, Silvana De & Myklebust, Lars Henrik Ryther [Show all 9 contributors for this article] (2024). Patient Characteristics From Norway’s First Heroin-Assisted Treatment Clinics. Substance use & addiction journal. 46(1), p. 13–24. doi: 10.1177/29767342241271991. Full text in Research Archive Show summary

  Background: Heroin-assisted treatment (HAT) is an evidence-based treatment option for opioid use disorder (OUD), available in a limited number of countries. Norway implemented a 5-year HAT project in 2022, aiming to assess its effectiveness and its potential integration into the country’s OUD treatment system. This study describes and compares patients’ baseline characteristics from the Oslo and Bergen HAT clinics, providing a comprehensive picture of the unique population and the real-world application of HAT. Methods: This cross-sectional study examines the baseline characteristics of consenting HAT patients within the first 2 years of operation (n = 86). Self-reported questionnaires gathered sociodemographics, previous treatment experiences, self-reported crime, and substance use, as well as motivations and expectations for treatment. Comparisons between the clinics were carried out using t-tests, Mann–Whitney U tests, Chi-square, and Fisher’s exact test. Results: The majority of the patients were enrolled at the Oslo clinic (76%) and were male (80%). At admission, the average age was 45.9, with a significantly younger group in Bergen (42.5 vs 47.3, P < .05). While no patients reported being unhoused, 17% noted unstable housing within the preceding month. Unemployment was prevalent (91%) alongside previous treatment experiences (95%), with a median of 2 prior medication types. In the 3 months preceding HAT initiation, 78% of patients reported being victims of crime, and 44% committed at least one crime. Over their lifetime, 2 in 5 participants (41%) had experienced an unwanted overdose and 43% had shared syringes and equipment. Conclusion: This study reveals a cohort experiencing societal marginalization, including unstable housing, unsatisfactory prior OUD treatment, high-risk behaviors, and frequent interactions with criminal activities, predominantly as victims. While the Oslo and Bergen clinics serve a similar patient profile, notable differences emerged in the reasons for discontinuing past OUD treatment and crime-related factors.

• Brummer, Julie Elizabeth; Thylstrup, Birgitte; Melis, Francesca & Hesse, Morten (2024). Predictors of retention in heroin-assisted treatment in Denmark 2010–2018 – A record-linkage study. Journal of Substance Use and Addiction Treatment. ISSN 2949-8767. 165. doi: 10.1016/j.josat.2024.209449. Full text in Research Archive Show summary

  Introduction While randomized-controlled trials have shown that heroin-assisted treatment (HAT) is superior to methadone maintenance alone in treatment of refractory clients, little is known about client factors associated with retention in HAT in routine care. Methods This retrospective cohort study assessed predictors of retention in first treatment episode among a consecutive cohort of clients admitted to HAT in Denmark from 2010 to 2018, who could be matched to the Danish population register and for whom a Short Form Health Survey (SF-36) was available at admission (N = 432). The study derived predictors from client self-reports at intake and administrative data available in national registers. Cox proportional hazards regression modelled retention in treatment. Results The one-year retention rate was 69.63 % (95 % CI 65.06 %–73.74 %), and the median time in treatment was 2.45 years (95 % CI, 1.83–3.12). Bivariate analyses showed that retention was lower for clients who had recent cocaine or benzodiazepine use and among those who had experienced an overdose in the year prior to enrollment in HAT. Age below 40, recent illegal activity, poorer emotional wellbeing, previous residential treatment experience, and previous intensive outpatient treatment were also predictors of dropout from HAT. Conclusions This observational study found that retention in HAT in routine care was similar to rates observed in randomized-controlled trials conducted in other countries. The results suggest that addressing polysubstance use as part of the HAT program may promote long-term retention, as may directing resources to certain subgroups identified at intake, including clients under 40 years and those who report recent criminal activity, emotional problems, or overdoses. The findings that previous residential treatment and intensive outpatient treatment were associated with dropout were unexpected.

• Biagioni, Silvia; Baroni, Marina; Melis, Francesca; Baldini, Federica; Menicucci, Danilo & Potente, Roberta [Show all 7 contributors for this article] (2023). Cyberbullying Roles and the Use of Psychoactive Substances: A Systematic Review. Adolescent Research Review. ISSN 2363-8346. doi: 10.1007/s40894-023-00205-z. Full text in Research Archive
• Melis, Francesca; Hesse, Morten; Eide, Desiree; Thylstrup, Birgitte; Tjagvad, Christian & Brummer, Julie Elizabeth [Show all 7 contributors for this article] (2023). Who receives heroin-assisted treatment? A comparison of patients receiving opioid maintenance treatment in Denmark. Drug and Alcohol Dependence. ISSN 0376-8716. 254. doi: 10.1016/j.drugalcdep.2023.111051. Full text in Research Archive Show summary

  Background Since 2010, heroin-assisted treatment (HAT) has been one of the treatment options available to people with opioid use disorder (OUD) in Denmark. This study aimed to characterize HAT patients at treatment start and compare their individual characteristics to those of patients entering traditional opioid maintenance treatment (OMT) with methadone or buprenorphine during the same period. Methods Patients who initiated HAT or OMT with methadone or buprenorphine in Denmark from 2010 to 2018 were included (n=6798). Multiple national registers were linked to compare treatment groups in terms of socio-demographic variables, previous OUD treatment episodes, hospital-based care, and criminal conviction history. Results Nearly all HAT patients had a history of methadone treatment (91%) and half had residential treatment experience (48%). In the year previous to admission, HAT patients recorded the highest percentages of non-fatal overdoses (12%) and chronic hepatitis C diagnoses (16%), and the lowest percentages of psychiatric disorders (11%) compared to traditional OMT patients. Criminal convictions were also common: 39% of the HAT group had committed a property crime and 18% a drug-related crime the year before HAT entry. During the study period, an overall reduction in OMT enrollments for each year was recorded. The HAT proportion to the total remained fairly stable (4%−10%), while the buprenorphine proportion increased. Conclusions In Denmark, OMT patients exhibited numerous vulnerabilities at treatment start, and among the patient groups, HAT patients were the most burdened. HAT seems to reach the target group and adhere to formulated eligibility criteria.

• Biagioni, Silvia; Baldini, Federica; Baroni, Marina; Cerrai, Sonia; Melis, Francesca & Potente, Roberta [Show all 8 contributors for this article] (2022). Adolescents’ Psychoactive Substance Use During the First COVID-19 Lockdown: A Cross Sectional Study in Italy. Child and Youth Care Forum. ISSN 1053-1890. doi: 10.1007/s10566-022-09701-0. Full text in Research Archive

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• Melis, Francesca (2025). Quality of life in heroin-assisted treatment. Full text in Research Archive Show summary

  10 minutes presentation about my PhD topic and process

• Melis, Francesca (2025). Beyond health: quality of life in heroin-assisted treatment. Full text in Research Archive
• Melis, Francesca (2024). QoL preliminary results (livskvalitet). Full text in Research Archive
• Melis, Francesca (2024). Health-related quality of life trajectories of patients in heroin-assisted treatment. Full text in Research Archive
• Myklebust, Lars Henrik Ryther; Eide, Desiree; Arnevik, Espen Ajo; Dadras, Omid; Pirro, Silvana De & Ellefsen, Rune [Show all 14 contributors for this article] (2024). Evaluation of heroin-assisted treatment in Norway: protocol for a mixed methods study. BMC Health Services Research. 24(1). doi: 10.1186/s12913-024-10767-w. Full text in Research Archive Show summary

  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.

• Eide, Desiree; Pirro, Silvana De; Myklebust, Lars Henrik Ryther; Melis, Francesca; Oldervoll, Ann & Clausen, Thomas (2024). Norway's first heroin-assisted treatment clinics: initial impact of the intervention. Full text in Research Archive
• Melis, Francesca (2023). What becomes of the research done in the clinic? Some preliminary results. Full text in Research Archive
• Melis, Francesca; Clausen, Thomas; Thylstrup, Birgitte; Tjagvad, Christian & Eide, Desiree (2025). Evaluering af behandling med lægeordineret heroin i Danmark. University of Oslo (UiO). doi: https:/www.med.uio.no/klinmed/forskning/sentre/seraf/aktuelt/aktuelle-saker/2025/seraf-rapport-2025.pdf. Full text in Research Archive Show summary

  The purpose of the report is to conduct an evaluation of the Danish HAT program. The report includes how the program has evolved since its implementation in 2010, program challenges from different perspectives and potential areas for improvement, particularly as it relates to patient dignity. The evaluation offers insights into patient outcomes while in treatment, staff and patient impressions on treatment, staff opinions on the treatment guidelines, and operational differences between the five clinics. This evaluation did not conduct a cost-benefit analysis, nor does it offer recommendations for how to update clinical practices guidelines. Such evaluations are outside the scope of this report.

• Eide, Desiree; Bjørnestad, Ronny; Brummer, Julie Elizabeth; Dadras, Omid; Pirro, Silvana De & Ellefsen, Rune [Show all 17 contributors for this article] (2024). Midtveisrapport om heroinassistert behandling fra 2022-2023 (SERAF rapport 4/2024). Senter for rus- og avhengighetsforskning. Full text in Research Archive Show summary

  Denne midtveisrapporten tar for seg de to første årene av Norges første heroinassisterte behandlingsprogram (HAB) som er planlagt å vare ut 2026 som et tidsavgrenset klinisk forsøksprosjekt. Forsøksprosjektet HAB ble etablert som del av legemiddelassistert rehabilitering (LAR) i Oslo og Bergen. Fra 1. januar 2022 til 31. desember 2023 ble 92 av totalt 97 pasienter inkludert i forskningsprosjektet som skal evaluere de to nyetablerte HABklinikkene. Denne rapporten beskriver etableringen av klinikkene, pasienterfaringer og pasientrapporterte resultater mens de var i heroinassistert behandling. Denne rapporten gir en midtveisevaluering av forsøksprosjektet. En endelig og utvidet evalueringsrapport vil bli levert i løpet av første halvdel av 2026.

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