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Individuals with physical comorbidities and polypharmacy may be at higher risk of depression relapse, however, they are not included in the ‘high risk of relapse’ group for whom longer antidepressant treatment durations are recommended.
Aims
In individuals with comorbid depression and type 2 diabetes (T2DM), we aimed to investigate the association and interaction between depression relapse and (a) polypharmacy, (b) previous duration of antidepressant treatment.
Method
This was a cohort study using primary care data from the UK Clinical Practice Research Datalink (CPRD) from years 2000 to 2018. We used Cox regression models with penalised B-splines to describe the association between restarting antidepressants and our two exposures.
Results
We identified 48 001 individuals with comorbid depression and T2DM, who started and discontinued antidepressant treatment during follow-up. Within 1 year of antidepressant discontinuation, 35% of participants restarted treatment indicating depression relapse. As polypharmacy increased, the rate of restarting antidepressants increased until a maximum of 18 concurrent medications, where individuals were more than twice as likely to restart antidepressants (hazard ratio (HR) = 2.15, 95% CI 1.32–3.51). As the duration of previous antidepressant treatment increased, the rate of restarting antidepressants increased – individuals with a previous duration of ≥25 months were more than twice as likely to restart antidepressants than those who previously discontinued in <7 months (HR = 2.36, 95% CI 2.25–2.48). We found no interaction between polypharmacy and previous antidepressant duration.
Conclusions
Polypharmacy and longer durations of previous antidepressant treatment may be associated with depression relapse following the discontinuation of antidepressant treatment.
We present the Widefield ASKAP L-band Legacy All-sky Blind surveY (WALLABY) Pilot Phase I Hi kinematic models. This first data release consists of Hi observations of three fields in the direction of the Hydra and Norma clusters, and the NGC 4636 galaxy group. In this paper, we describe how we generate and publicly release flat-disk tilted-ring kinematic models for 109/592 unique Hi detections in these fields. The modelling method adopted here—which we call the WALLABY Kinematic Analysis Proto-Pipeline (WKAPP) and for which the corresponding scripts are also publicly available—consists of combining results from the homogeneous application of the FAT and 3DBarolo algorithms to the subset of 209 detections with sufficient resolution and
$S/N$
in order to generate optimised model parameters and uncertainties. The 109 models presented here tend to be gas rich detections resolved by at least 3–4 synthesised beams across their major axes, but there is no obvious environmental bias in the modelling. The data release described here is the first step towards the derivation of similar products for thousands of spatially resolved WALLABY detections via a dedicated kinematic pipeline. Such a large publicly available and homogeneously analysed dataset will be a powerful legacy product that that will enable a wide range of scientific studies.
We present WALLABY pilot data release 1, the first public release of H i pilot survey data from the Wide-field ASKAP L-band Legacy All-sky Blind Survey (WALLABY) on the Australian Square Kilometre Array Pathfinder. Phase 1 of the WALLABY pilot survey targeted three
$60\,\mathrm{deg}^{2}$
regions on the sky in the direction of the Hydra and Norma galaxy clusters and the NGC 4636 galaxy group, covering the redshift range of
$z \lesssim 0.08$
. The source catalogue, images and spectra of nearly 600 extragalactic H i detections and kinematic models for 109 spatially resolved galaxies are available. As the pilot survey targeted regions containing nearby group and cluster environments, the median redshift of the sample of
$z \approx 0.014$
is relatively low compared to the full WALLABY survey. The median galaxy H i mass is
$2.3 \times 10^{9}\,{\rm M}_{{\odot}}$
. The target noise level of
$1.6\,\mathrm{mJy}$
per 30′′ beam and
$18.5\,\mathrm{kHz}$
channel translates into a
$5 \sigma$
H i mass sensitivity for point sources of about
$5.2 \times 10^{8} \, (D_{\rm L} / \mathrm{100\,Mpc})^{2} \, {\rm M}_{{\odot}}$
across 50 spectral channels (
${\approx} 200\,\mathrm{km \, s}^{-1}$
) and a
$5 \sigma$
H i column density sensitivity of about
$8.6 \times 10^{19} \, (1 + z)^{4}\,\mathrm{cm}^{-2}$
across 5 channels (
${\approx} 20\,\mathrm{km \, s}^{-1}$
) for emission filling the 30′′ beam. As expected for a pilot survey, several technical issues and artefacts are still affecting the data quality. Most notably, there are systematic flux errors of up to several 10% caused by uncertainties about the exact size and shape of each of the primary beams as well as the presence of sidelobes due to the finite deconvolution threshold. In addition, artefacts such as residual continuum emission and bandpass ripples have affected some of the data. The pilot survey has been highly successful in uncovering such technical problems, most of which are expected to be addressed and rectified before the start of the full WALLABY survey.
Health workforce development is essential for achieving the goals of an effective health system, as well as establishing national Health Emergency and Disaster Risk Management (Health EDRM).
Study Objective:
The objective of this Delphi consensus study was to identify strategic recommendations for strengthening the workforce for Health EDRM in low- and middle-income countries (LMIC) and high-income countries (HIC).
Methods:
A total of 31 international experts were asked to rate the level of importance (one being strongly unimportant to seven being strongly important) for 46 statements that contain recommendations for strengthening the workforce for Health EDRM. The experts were divided into a LMIC group and an HIC group. There were three rounds of rating, and statements that did not reach consensus (SD ≥ 1.0) proceeded to the next round for further ranking.
Results:
In total, 44 statements from the LMIC group and 34 statements from the HIC group attained consensus and achieved high mean scores for importance (higher than five out of seven). The components of the World Health Organization (WHO) Health EDRM Framework with the highest number of recommendations were “Human Resources” (n = 15), “Planning and Coordination” (n = 7), and “Community Capacities for Health EDRM” (n = 6) in the LMIC group. “Policies, Strategies, and Legislation” (n = 7) and “Human Resources” (n = 7) were the components with the most recommendations for the HIC group.
Conclusion:
The expert panel provided a comprehensive list of important and actionable strategic recommendations on workforce development for Health EDRM.
Long-acting injectable (LAI) antipsychotics and community treatment orders (CTOs) are used in patients with schizophrenia to improve treatment effectiveness through adherence.
Objectives
Understanding healthcare resource utilization (HRU) and associated costs, and medication adherence in patients with schizophrenia overall and by CTO status before and after second generation antipsychotic (SGA) LAI initiation may guide strategies to optimize health.
Methods
A retrospective observational single-arm study using administrative data from Alberta was performed. Adults with schizophrenia who initiated SGA-LAI (index date) were included. Medication possession ratio (MPR) was determined; paired t-tests were used to examine differences in HRU and costs ($CDN) between the 2-year pre-index period and 2-year post-index period. Stratified analysis by presence or absence of an active CTO during the pre-post periods was performed.
Results
Among 1,211 patients who initiated SGA-LAIs, MPR was greater post-index (0.84) compared with pre-index (0.45; 95% confidence interval [CI] 0.36, 0.41). All-cause and mental health-related HRU and costs were lower post-index versus pre-index (p<0.001); total all-cause HRU costs were $33,788 lower post- versus pre-index ($40,343 [standard deviation, SD $68,887] versus $74,131 [SD $75,941], 95% CI [-$38,993, -$28,583]), and total mental health-related HRU costs were $34,198 lower post- versus pre-index ($34,205 [SD $63,428] CDN versus $68,403 [SD $72,088] CDN, 95%CI [-$39,098, -$29,297]). Forty-three percent had ≥1 active CTO during the study period; HRU and costs varied according to CTO status.
Conclusions
SGA-LAIs are associated with improved adherence, and lower HRU and costs however the latter vary according to CTO status.
Disclosure
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this abstract: SD and MS have no competing interest to declare. LR, SK, KW, and KM are members of the Real-World Evidence
Mental health and psychosocial support (MHPSS) staff in humanitarian settings have limited access to clinical supervision and are at high risk of experiencing burnout. We previously piloted an online, peer-supervision program for MHPSS professionals working with displaced Rohingya (Bangladesh) and Syrian (Turkey and Northwest Syria) communities. Pilot evaluations demonstrated that online, peer-supervision is feasible, low-cost, and acceptable to MHPSS practitioners in humanitarian settings.
Objectives
This project will determine the impact of online supervision on i) the wellbeing and burnout levels of local MHPSS practitioners, and ii) practitioner technical skills to improve beneficiary perceived service satisfaction, acceptability, and appropriateness.
Methods
MHPSS practitioners in two contexts (Bangladesh and Turkey/Northwest Syria) will participate in 90-minute group-based online supervision, fortnightly for six months. Sessions will be run on zoom and will be co-facilitated by MHPSS practitioners and in-country research assistants. A quasi-experimental multiple-baseline design will enable a quantitative comparison of practitioner and beneficiary outcomes between control periods (12-months) and the intervention. Outcomes to be assessed include the Kessler-6, Harvard Trauma Questionnaire and Copenhagen Burnout Inventory and Client Satisfaction Questionnaire-8.
Results
A total of 80 MHPSS practitioners will complete 24 monthly online assessments from May 2022. Concurrently, 1920 people receiving MHPSS services will be randomly selected for post-session interviews (24 per practitioner).
Conclusions
This study will determine the impact of an online, peer-supervision program for MHPSS practitioners in humanitarian settings. Results from the baseline assessments, pilot evaluation, and theory of change model will be presented.
Patients with bipolar disorder (BPD) are prone to engage in risk-taking behaviours and self-harm, contributing to higher risk of traumatic injuries requiring medical attention at the emergency room (ER).We hypothesize that pharmacological treatment of BPD could reduce the risk of traumatic injuries by alleviating symptoms but evidence remains unclear. This study aimed to examine the association between pharmacological treatment and the risk of ER admissions due to traumatic injuries.
Methods
Individuals with BPD who received mood stabilizers and/or antipsychotics were identified using a population-based electronic healthcare records database in Hong Kong (2001–2019). A self-controlled case series design was applied to control for time-invariant confounders.
Results
A total of 5040 out of 14 021 adults with BPD who received pharmacological treatment and had incident ER admissions due to traumatic injuries from 2001 to 2019 were included. An increased risk of traumatic injuries was found 30 days before treatment [incidence rate ratio (IRR) 4.44 (3.71–5.31), p < 0.0001]. After treatment initiation, the risk remained increased with a smaller magnitude, before returning to baseline [IRR 0.97 (0.88–1.06), p = 0.50] during maintenance treatment. The direct comparison of the risk during treatment to that before and after treatment showed a significant decrease. After treatment cessation, the risk was increased [IRR 1.34 (1.09–1.66), p = 0.006].
Conclusions
This study supports the hypothesis that pharmacological treatment of BPD was associated with a lower risk of ER admissions due to traumatic injuries but an increased risk after treatment cessation. Close monitoring of symptoms relapse is recommended to clinicians and patients if treatment cessation is warranted.
Background: New-onset refractory status epilepticus (NORSE) is a rare clinical presentation affecting previously healthy individuals. Febrile infection-related epilepsy syndrome (FIRES) is a subcategory of NORSE and applies when a preceding fever occurs. The NORSE/FIRES Family Registry has been developed to gain insight into risk factors and to assess the spectrum of clinical outcomes amongst survivors. Methods: Survivors, surrogates, and physicians can enter patient data into the REDCap-based registry: https://www.norseinstitute.org/norse-registry-2. Information collected includes medical history, clinical presentation, and quality of life, among others. Participants are invited to complete follow-up surveys for up to two years following presentation of seizures. Enrollment is ongoing in multiple languages. Results: 56 participants are enrolled from 12 countries (2-78 years, median: 12.5, IQR: 20.5, 31 survivors). At ≥6 months after onset, survivors experience a mean of ≥12 seizures per month and remain on a median of 4 (IQR: 3) anti-seizure medications. The median quality of life amongst all survivors was rated 4/10 (IQR: 3.5). Conclusions: Preliminary data suggests that survivors of NORSE/FIRES have a high seizure burden and poor quality of life. This international multi-lingual family registry will help develop hypotheses for future studies and provides an opportunity for families to contribute to the scientific understanding of this disease.
Young people are most vulnerable to suicidal behaviours but least likely to seek help. A more elaborate study of the intrinsic and extrinsic correlates of suicidal ideation and behaviours particularly amid ongoing population-level stressors and the identification of less stigmatising markers in representative youth populations is essential.
Methods
Participants (n = 2540, aged 15–25) were consecutively recruited from an ongoing large-scale household-based epidemiological youth mental health study in Hong Kong between September 2019 and 2021. Lifetime and 12-month prevalence of suicidal ideation, plan, and attempt were assessed, alongside suicide-related rumination, hopelessness and neuroticism, personal and population-level stressors, family functioning, cognitive ability, lifetime non-suicidal self-harm, 12-month major depressive disorder (MDD), and alcohol use.
Results
The 12-month prevalence of suicidal ideation, ideation-only (no plan or attempt), plan, and attempt was 20.0, 15.4, 4.6, and 1.3%, respectively. Importantly, multivariable logistic regression findings revealed that suicide-related rumination was the only factor associated with all four suicidal outcomes (all p < 0.01). Among those with suicidal ideation (two-stage approach), intrinsic factors, including suicide-related rumination, poorer cognitive ability, and 12-month MDE, were specifically associated with suicide plan, while extrinsic factors, including coronavirus disease 2019 (COVID-19) stressors, poorer family functioning, and personal life stressors, as well as non-suicidal self-harm, were specifically associated with suicide attempt.
Conclusions
Suicide-related rumination, population-level COVID-19 stressors, and poorer family functioning may be important less-stigmatising markers for youth suicidal risks. The respective roles played by not only intrinsic but also extrinsic factors in suicide plan and attempt using a two-stage approach should be considered in future preventative intervention work.
The surge in critically ill patients has pressured hospitals to expand their intensive care unit capacities and critical care staff. This was difficult given the country’s shortage of intensivists. This paper describes the implementation of a multidisciplinary central line placement team and its impact in reducing the vascular access workload of ICU physicians during the height of the COVID-19 pandemic.
Methods:
Vascular surgeons, interventionalists, and anesthesiologists, were redeployed to the ICU Access team to place central and arterial lines. Nurses with expertise in vascular access were recruited to the team to streamline consultation and assist with line placement.
Results:
While 51 central and arterial lines were placed per 100 ICU patients in 2019, there were 87 central and arterial lines placed per 100 COVID-19 ICU patients in the sole month of April, 2020. The ICU Access Team placed 107 of the 226 vascular access devices in April 2020, reducing the procedure-related workload of ICU treating teams by 46%.
Conclusions:
The ICU Access Team was able to complete a large proportion of vascular access insertions without reported complications. Given another mass casualty event, this ICU Access Team could be reassembled to rapidly meet the increased vascular access needs of patients.
Influenza virus infections can lead to a number of secondary complications, including sepsis. We applied linear regression models to mortality and hospital admission data coded for septicaemia from 1998 to 2019 in Hong Kong, and estimated that septicaemia was associated with an annual average excess mortality rate of 0.23 (95% CI 0.04–0.40) per 100 000 persons per year and an excess septicaemia hospitalisation rate of 1.73 (95% CI 0.94–2.50) per 100 000 persons per year. The highest excess morbidity and mortality was found in older adults and young children, and during influenza A(H3N2) epidemics.
We describe the scientific goals and survey design of the First Large Absorption Survey in H i (FLASH), a wide field survey for 21-cm line absorption in neutral atomic hydrogen (H i) at intermediate cosmological redshifts. FLASH will be carried out with the Australian Square Kilometre Array Pathfinder (ASKAP) radio telescope and is planned to cover the sky south of
$\delta \approx +40\,\deg$
at frequencies between 711.5 and 999.5 MHz. At redshifts between
$z = 0.4$
and
$1.0$
(look-back times of 4 – 8 Gyr), the H i content of the Universe has been poorly explored due to the difficulty of carrying out radio surveys for faint 21-cm line emission and, at ultra-violet wavelengths, space-borne searches for Damped Lyman-
$\alpha$
absorption in quasar spectra. The ASKAP wide field of view and large spectral bandwidth, in combination with a radio-quiet site, will enable a search for absorption lines in the radio spectra of bright continuum sources over 80% of the sky. This survey is expected to detect at least several hundred intervening 21-cm absorbers and will produce an H i-absorption-selected catalogue of galaxies rich in cool, star-forming gas, some of which may be concealed from optical surveys. Likewise, at least several hundred associated 21-cm absorbers are expected to be detected within the host galaxies of radio sources at
$0.4 < z < 1.0$
, providing valuable kinematical information for models of gas accretion and jet-driven feedback in radio-loud active galactic nuclei. FLASH will also detect OH 18-cm absorbers in diffuse molecular gas, megamaser OH emission, radio recombination lines, and stacked H i emission.
Multisystem inflammatory syndrome in adults (MIS-A) is a hyperinflammatory illness related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The characteristics of patients with this syndrome and the frequency with which it occurs among patients hospitalised after SARS-CoV-2 infection are unclear. Using the Centers for Disease Control and Prevention case definition for MIS-A, we created ICD-10-CM code and laboratory criteria to identify potential MIS-A patients in the Premier Healthcare Database Special COVID-19 Release, a database containing patient-level information on hospital discharges across the United States. Modified MIS-A criteria were applied to hospitalisations with discharge from March to December 2020. The proportion of hospitalisations meeting electronic health record criteria for MIS-A and descriptive statistics for patients in the potential MIS-A cohort were calculated. Of 34 515 SARS-CoV-2-related hospitalisations with complete clinical and laboratory data, 53 met modified criteria for MIS-A (0.15%). The median age was 62 years (IQR 52–74). Most patients met the severe cardiac illness criterion through either myocarditis (66.0%) or new-onset heart failure (35.8%). A total of 79.2% of patients required ICU admission, while 43.4% of patients in the cohort died. MIS-A appears to be a rare but severe outcome of SARS-CoV-2 infection. Additional studies are needed to investigate how this syndrome differs from severe coronavirus disease 2019 (COVID-19) in adults.
Background: Spinal cord compression from degenerative cervical myelopathy is characterized by progressive loss of hand dexterity, alongside changes in the metabolite profiles in the brain and spinal cord. Correlating the changing metabolite profile with measures of dexterity following decompression surgery may assist in identifying which patients may benefit most from surgery. Methods: Thirty operative myelopathy patients consented to receive spectroscopy and GRASSP-M dexterity assessments both preoperatively and 6-weeks postoperatively. Magnetic resonance spectroscopy (TE=135) was performed in the motor cortex using a 3 Tesla Siemens MRI scanner at Robarts Research Institute. Spearman correlations were used to evaluate associations between metabolite levels and dexterity (p<0.05 was considered significant). Paired two-tailed Student t-tests were used to assess for postoperative changes in metabolite levels. Results: Postoperatively, we observed a statistically significant (p<0.05) negative correlation (r=-0.44) between the N-acetylaspartate-to-creatine ratio (NAA/Cr) and GRASSP-M dexterity scores. There was no significant difference in NAA, Cr, or NAA/Cr postoperatively. Conclusions: These findings demonstrate that patients with lower postoperative NAA/Cr usually have better recovery of dexterity. This link between the myelopathic metabolite profile and clinically meaningful dexterity values requires further investigation to understand the role of both NAA and Cr in mechanisms of postoperative recovery from myelopathy.
In this chapter, we provide a historical and a contemporary overview of the hearing brain. We will review how various brain-imaging methods are employed to study how sounds and meanings are represented in the brain. These studies have provided the foundation from which network models of the brain are built. We will conclude with a discussion of the practical aspects of the neuroscience of language, such as how it will further our understanding of the brain and lead to clinical applications.
The risk of antipsychotic-associated cardiovascular and metabolic events may differ among countries, and limited real-world evidence has been available comparing the corresponding risks among children and young adults. We, therefore, evaluated the risks of cardiovascular and metabolic events in children and young adults receiving antipsychotics.
Methods
We conducted a multinational self-controlled case series (SCCS) study and included patients aged 6–30 years old who had both exposure to antipsychotics and study outcomes from four nationwide databases of Taiwan (2004–2012), Korea (2010–2016), Hong Kong (2001–2014) and the UK (1997–2016) that covers a total of approximately 100 million individuals. We investigated three antipsychotics exposure windows (i.e., 90 days pre-exposure, 1–30 days, 30–90 days and 90 + days of exposure). The outcomes were cardiovascular events (stroke, ischaemic heart disease and acute myocardial infarction), or metabolic events (hypertension, type 2 diabetes mellitus and dyslipidaemia).
Results
We included a total of 48 515 individuals in the SCCS analysis. We found an increased risk of metabolic events only in the risk window with more than 90-day exposure, with a pooled IRR of 1.29 (95% CI 1.20–1.38). The pooled IRR was 0.98 (0.90–1.06) for 1–30 days and 0.88 (0.76–1.02) for 31–90 days. We found no association in any exposure window for cardiovascular events. The pooled IRR was 1.86 (0.74–4.64) for 1–30 days, 1.35 (0.74–2.47) for 31–90 days and 1.29 (0.98–1.70) for 90 + days.
Conclusions
Long-term exposure to antipsychotics was associated with an increased risk of metabolic events but did not trigger cardiovascular events in children and young adults.
Brief measurements of the subjective experience of stress with good predictive capability are important in a range of community mental health and research settings. The potential for large-scale implementation of such a measure for screening may facilitate early risk detection and intervention opportunities. Few such measures however have been developed and validated in epidemiological and longitudinal community samples. We designed a new single-item measure of the subjective level of stress (SLS-1) and tested its validity and ability to predict long-term mental health outcomes of up to 12 months through two separate studies.
Methods
We first examined the content and face validity of the SLS-1 with a panel consisting of mental health experts and laypersons. Two studies were conducted to examine its validity and predictive utility. In study 1, we tested the convergent and divergent validity as well as incremental validity of the SLS-1 in a large epidemiological sample of young people in Hong Kong (n = 1445). In study 2, in a consecutively recruited longitudinal community sample of young people (n = 258), we first performed the same procedures as in study 1 to ensure replicability of the findings. We then examined in this longitudinal sample the utility of the SLS-1 in predicting long-term depressive, anxiety and stress outcomes assessed at 3 months and 6 months (n = 182) and at 12 months (n = 84).
Results
The SLS-1 demonstrated good content and face validity. Findings from the two studies showed that SLS-1 was moderately to strongly correlated with a range of mental health outcomes, including depressive, anxiety, stress and distress symptoms. We also demonstrated its ability to explain the variance explained in symptoms beyond other known personal and psychological factors. Using the longitudinal sample in study 2, we further showed the significant predictive capability of the SLS-1 for long-term symptom outcomes for up to 12 months even when accounting for demographic characteristics.
Conclusions
The findings altogether support the validity and predictive utility of the SLS-1 as a brief measure of stress with strong indications of both concurrent and long-term mental health outcomes. Given the value of brief measures of mental health risks at a population level, the SLS-1 may have potential for use as an early screening tool to inform early preventative intervention work.
Despite its efficacy in treating comorbid insomnia and depression, cognitive behavioral therapy for insomnia (CBT-I) is limited in its accessibility and, in many countries, cultural compatibility. Smartphone-based treatment is a low-cost, convenient alternative modality. This study evaluated a self-help smartphone-based CBT-I in alleviating major depression and insomnia.
Methods
A parallel-group randomized, waitlist-controlled trial was conducted with 320 adults with major depression and insomnia. Participants were randomized to receive either a 6-week CBT-I via a smartphone application, proACT-S, or waitlist condition. The primary outcomes included depression severity, insomnia severity, and sleep quality. The secondary outcomes included anxiety severity, subjective health, and acceptability of treatment. Assessments were administered at baseline, post-intervention (week 6) follow-up, and week 12 follow-up. The waitlist group received treatment after the week 6 follow-up.
Results
Intention to treat analysis was conducted with multilevel modeling. In all but one model, the interaction between treatment condition and time at week 6 follow-up was significant. Compared with the waitlist group, the treatment group had lower levels of depression [Center for Epidemiologic Studies Depression Scale (CES-D): Cohen's d = 0.86, 95% CI (−10.11 to −5.37)], insomnia [Insomnia Severity Index (ISI): Cohen's d = 1.00, 95% CI (−5.93 to −3.53)], and anxiety [Hospital Anxiety and Depression Scale – Anxiety subscale (HADS-A): Cohen's d = 0.83, 95% CI (−3.75 to −1.96)]. They also had better sleep quality [Pittsburgh Sleep Quality Index (PSQI): Cohen's d = 0.91, 95% CI (−3.34 to −1.83)]. No differences across any measures were found at week 12, after the waitlist control group received the treatment.
Conclusion
proACT-S is an efficacious sleep-focused self-help treatment for major depression and insomnia.
Opium tincture (OT) is widely used for opioid substitution treatment (OST) in Iran.
Objectives
To determine if OT is a safe and effective medication for OST.
Methods
Opium Trial was a multicenter, double‐blind, noninferiority randomized controlled trial, with 204 participants with opioid dependence in Iran. Participants were then randomized to OT or methadone arms with an allocation ratio of 1:1 and were followed for 12 weeks. The primary outcome was retention in treatment, compared between the two groups using both intention-To-Treat (ITT) and Per-Protocol (PP) analyses.
Results
A total of 70 participants (IT: 68.6%, PP: 69.3%) in methadone arm and 61 participants (ITT: 59.8%, PP: 60.4%) in OT arm remained in the treatment. The relative retention rate was 1.15 (0.97, 1.36) in both analyses in favour of methadone. A total of 46 out of 152 (30.3%) participants in OT arm and 83 out of 168 (49.4%) participants in methadone arm reported opioid use outside the treatment. The difference in these two proportions (OT - methadone) was 19%: (10%, 28%) in favour of OT. The proportion of patients with adverse events were not different between the two arms (P = 0.06). There was no serious AE in OT arm.
Conclusions
Opium tincture is a clinically effective and safe medication, but this study could not conclude if it was as equally effective as methadone in retaining participants in treatment, but it showed that OT was superior to methadone in reducing opioid use outside the treatment.