Quality of life of patients treated with opium tincture or methadone: A randomized controlled trial.

OBJECTIVE: Quality of life (QoL) is an increasingly recognized patient-centered treatment outcome in individuals with opioid use disorder. There is a gap in literature on the impact of opium tincture (OT) on patients' QoL compared to standard treatment options such as methadone. This study aimed to compare the QoL of participants with opioid use disorder receiving OAT using OT or methadone and identify the factors associated with their QoL during treatment. METHODS: The opium trial was a multicenter non-inferiority randomized clinical trial in four private OAT outpatient clinics in Iran. The study assigned patients to either OT (10 mg/ml) or methadone sirup (5 mg/ml) for a follow-up of 85 days. QoL was assessed using the brief version of the World Health Organization Quality of Life instrument (WHOQOL- BREF). RESULTS: A total of 83 participants, 35 (42.2%) in the OT arm and 48 (57.8%) in the methadone arm, completed the WHOQOL-BREF in full and were included in the primary analysis. The mean score of patients' QoL showed improvement compared to baseline, but differences were not statistically significant between OT and methadone arms (p = 0.786). Improvements were mainly observed within the first 30 days of receiving treatment. Being married and lower psychological distress were associated with an improved QoL. Within the social relationships domain, male gender showed significantly higher QoL compared to females. CONCLUSION: OT shows promise as an OAT medication, comparable to methadone in improving patients' QoL. There is a need to incorporate psychosocial interventions to further sustain and improve the QoL in this population. Identifying other social determinants of health which affect QoL and the cultural adaptation of assessments for individuals from various ethnocultural backgrounds are critical areas of inquiry.

Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial.

AIM: To test if opium tincture (OT) was non-inferior to methadone in retaining participants in opioid agonist treatment (OAT). DESIGN: A Phase III, multi-centre, parallel-group, non-inferiority, double-blind randomized controlled trial with an allocation ratio of 1:1. Participants were provided treatment and followed for a period of 85 days. SETTING: Four OAT clinics in Iran. PARTICIPANTS: Two hundred and four participants with opioid use disorder [mean age (standard deviation) = 37.4 (9.3); female 11.3%] recruited between July 2017 and January 2018. INTERVENTIONS: Participants were assigned to either OT (102) or methadone (102) using a patient-centred flexible dosing strategy. MEASUREMENTS: Treatment retention over 85 days was the primary outcome. Self-reported opioid use outside treatment and occurrence of adverse events (AEs) were the secondary outcomes. FINDINGS: Remaining in treatment at the end of the follow-up were 68.6% in the methadone arm and 59.8% in the OT arm. The relative retention rate of methadone to OT was 1.15 (0.97, 1.36) in both intent-to-treat and per-protocol analyses; non-inferiority was not supported statistically, as the upper bound of the confidence interval exceeded our pre-specified non-inferiority margin (1.25). Opioid use outside treatment was reported by 30.3% of OT (n = 152) and 49.4% of methadone (n = 168) patients, a difference in proportions of -19%: 90% confidence interval (-28%, -10%). The total count of AEs in the OT arm (22 among nine individuals) was significantly higher (P = 0.04) than that in the methadone arm (three among two individuals). Nausea was the most common side effect. CONCLUSION: While this study could not conclude the non-inferiority of opium tincture (OT) to methadone for retaining patients in opioid agonist treatment, OT retained 60% of participants to end of follow-up (85 days) and was superior to methadone in reducing self-reported opioid use outside treatment.

Chronic Pain among Individuals Experiencing Homelessness and Its Interdependence with Opioid and Other Substance Use and Mental Illness.

Chronic pain and substance use disorders are serious conditions that are prevalent among homeless populations. The aim of this study was to examine the association between chronic pain and substance use among individuals experiencing homelessness and mental illness. We analyzed cross-sectional data from two sites of the At Home/Chez Soi study (Vancouver and Toronto) using bivariate statistics and multivariate logistic regression. Substance use and chronic pain parameters were assessed with the Maudsley Addiction Profile and purpose-designed short instruments. The sample comprised 828 participants. Mean age was 42.4 years and 54% reported chronic pain. In bivariate analysis, chronic pain was significantly associated with use of opioids and stimulants, daily substance use, polysubstance use and injecting as route of administration. In multivariate analysis, only daily substance use (OR: 1.46, 95% CI: 1.02-2.09) and injecting (OR: 1.81, 95% CI: 1.08-3.05) remained as significant associated factors, whereas neither use of opioids nor use of stimulants specifically were significantly associated with chronic pain. Among participants with chronic pain, daily substance users (50% vs. 22%, p < 0.001) and injectors (66% vs. 24%, p < 0.001) were more likely to use non-prescribed medication for pain. Participants with daily substance use were less likely to receive professional treatment (52% vs. 64%, p = 0.017) and prescribed pain medication (42% vs. 54%, p = 0.023). Our findings suggest an association of chronic pain with patterns related to severity of substance use rather than to specific substance use in homeless persons with mental illness. Interventions aiming at prevention and treatment of chronic pain in this population should consider severity of substance use and associated risk behavior over use of specific substances.

Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial.

OBJECTIVES: This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder. METHODS: In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hypersensitivity to trial medications, pregnancy, and certain serious medical conditions. They were randomized to receive either OT or methadone with an allocation ratio of 1:1 using a patient-centered flexible dosing strategy. Eligible participants were followed for a period of 12 weeks. Primary outcome is the difference in percentage of patients retained in the treatment. Secondary outcomes are craving, withdrawal symptoms, physical health, mental health, quality of life, and severity of substance use problems, cognitive function, safety profile, cost-effectiveness, and participants' satisfaction. Both intention-to-treat and per-protocol analyses will be conducted. The Ethics Board of the University of British Columbia and Tehran University of Medical Sciences approved the study. (clinicaltrials.gov; NCT02502175). RESULTS: To be reported after final analysis. CONCLUSIONS: If shown to be effective, OT will diversify the options for medication-assisted treatment of opioid use disorder.

Hepatitis C prevalence and associated risk factors among individuals who are homeless and diagnosed with mental illness: At Home/Chez Soi Study, Vancouver, BC.

BACKGROUND: There is scarce evidence on prevalence of hepatitis C virus (HCV) infection among individuals who are homeless and diagnosed with severe mental illness. We aimed to investigate the prevalence of HCV infection and associated risk factors in a representative sample of adults from At Home study. METHODS: The Vancouver At Home study is part of the At Home/Chez Soi (AH/CS) project-a pragmatic randomized controlled trial of a Housing First intervention among homeless persons with mental illness in five Canadian cities between 2009 and 2013 with a 2-year follow-up period. RESULTS: Of 497 participants, 28% reported positive HCV serostatus. Educational level equal or less than eighth grade (AOR: 2.3, 95% CI: 1.1, 4.8), history of incarceration (AOR: 2.1, 95% CI: 1.2, 3.5), substance dependence (AOR: 2.0, 95% CI: 1.1, 3.7) and injection drug use during one month prior to the recruitment (AOR: 7.8, 95% CI: 4.0, 15.0) were associated with an increased risk of HCV infection. Having a psychotic disorder (AOR: 0.6, 95% CI: 0.3, 1.0) and age < 25 (AOR: 0.2, 95% CI: 0.0, 0.7) were associated with a lower risk. Blood tests performed on 30 participants agreed with self-report in 97% of cases [Kappa = 0.9 (95% CI: 0.6, 1.3), PABAK = 0.9]. CONCLUSION: The high prevalence of HCV among individuals who were homeless with mental illness underlies the importance of prevention and treatment of HCV in this population, especially those with concurrent substance use disorders. Self-report seems to be a valid tool for evaluation of the HCV status in this population.

Is bipolar disorder associated with tramautic brain injury in the homeless?

INTRODUCTION: Links between Bipolar Disorder (BD) and medical conditions are increasingly reported. Traumatic Brain Injury (TBI) is a prevalent medical condition found in homeless populations. urdens associated with BD in the homeless population. AIM: This paper examines the correlation between the presence of BD and TBI, comparing homeless affected by Bipolar Disorder, Unipolar Depression (UD) and Schizophrenia Spectrum Disorder (SSD), controlled for other TBI risk factors such as age, gender, comorbid alcohol and substance use disorders as the confounding variables. METHODS: From 489 participants of Vancouver arm of the At Home/Chez Soi Study, 416 homeless had psychiatric diagnoses, alcohol and substance dependence, and TBI determined by the MINI Questionnaire and the Comorbid Conditions List. 147 patients with BD were compared with 175 UD and 94 SSD for age, gender, the presence, number and severity of TBI and the presence of alcohol and substance use diagnosis, at a univariate and multivariate level. RESULTS: The homeless with BD had higher percentage of TBI compared to the homeless with SSD. However, the reported severity and frequency of TBI by patients with BD, UD, and SSD were not statistically different. BD diagnosis was associated with TBI at multivariate level. CONCLUSIONS: TBI could be considered one of the physical burdens associated with BD in the homeless population.

Chronic Pain Among Homeless Persons with Mental Illness.

OBJECTIVE: Chronic pain is an important public health issue. However, characteristics and needs of marginalized populations have received limited attention. Studies on prevalence and correlates of chronic pain among homeless persons are lacking. We assessed chronic pain among homeless persons with mental illness in the At Home/Chez Soi study. DESIGN: Cross-sectional data from a randomized controlled trial on homelessness and mental health. SETTING: Data collected between 2009 and 2013 in three Canadian cities. SUBJECTS: One thousand two hundred eighty-seven homeless persons with mental illness. METHODS: Data on chronic pain and utilization of prescribed and nonprescribed interventions was assessed using a chronic pain screening instrument. Mental illness was diagnosed with the Mini-International Neuropsychiatric Interview. RESULTS: Forty-three percent reported moderate to severe chronic pain, interfering with general daily activities (80%), sleep (78%), and social interactions (61%). Multivariate analysis indicated that increasing age and diagnoses of major depressive disorder, mood disorder with psychotic features, panic disorder, and post-traumatic stress disorder (PTSD) were independent predictors of chronic pain. Chronic pain was further associated with increased suicidality. Among participants reporting chronic pain, 64% had sought medical treatment and 56% treated pain with prescribed drugs, while 38% used illicit drugs for pain relief. CONCLUSIONS: Chronic pain is very common among homeless persons with mental illness and affects activities of daily living. Clinicians treating this population should be aware of the common connections between chronic pain, depression, panic disorder, PTSD, and substance use. While the data indicate the contribution of chronic pain to complex treatment needs, they also indicate a clear treatment gap.

Tincture of opium for treating opioid dependence: a systematic review of safety and efficacy.

BACKGROUND AND AIMS: Recently, there has been a growing interest in using opium tincture (OT) for treating opioid dependence in certain regions. We aimed to assess the evidence on its safety and efficacy for this indication. METHODS: We searched several databases (CENTRAL, Medline, EMBASE, Web of Science, PsychINFO, ProQuest Dissertation and Theses Database, Iran Medex, clinicaltrials.gov and who.int/trialsearch) with no language or publication date limitations. Two reviewers selected randomized controlled trials (RCT), cohort/case-control/cross-sectional studies and case-series on safety or efficacy of OT for treating opioid dependence and then extracted reported measures of mentioned outcomes from selected studies. We used the Effective Public Health Practice Project (EPHPP) Quality Assessment tool for appraisal. RESULTS: From nine selected studies; in three RCTs and one cohort analytical analysis on detoxification, 110 patients were treated with 15-140 morphine equivalents/day (mEq/d) of OT; in four prospective and one retrospective uncontrolled case-series on long-term/maintenance treatment, 570 patients were treated with 100-400 mEq/d of OT. Only two studies on detoxification included a comparison: one concluded equal efficacy of OT and methadone in suppressing withdrawal symptoms (P = 0.32) and the other concluded OT to be less efficacious than buprenorphine/naloxone in suppressing withdrawal [OT = 12.20, 95% confidence interval (CI) = 11.00, 13.40]; control: 5.20 (95% CI = 4.69, 5.71) and craving (OT = 303.0, 95% CI = -144.664, 750.664; control: 0.0) but not significantly different (P = 0.26) in retaining participants in treatment. No major adverse events were reported. CONCLUSIONS: Conclusive recommendations about the safety and efficacy of opium tincture for treating opioid dependence are not possible at this time.

Biofeedback for nonneuropathic daytime voiding disorders in children: a systematic review and meta-analysis of randomized controlled trials.

PURPOSE: Biofeedback has been used to treat children with symptoms of bladder dysfunction not responding to standard therapy alone. However, evidence of the effectiveness of biofeedback is scarce and is based on small studies. We conducted a systematic review of the literature to assess the effects of biofeedback as adjunctive therapy for symptoms of nonneuropathic voiding disorders in children up to age 18 years. MATERIALS AND METHODS: We searched MEDLINE(®), Embase(®) and CENTRAL on the OvidSP(®) platform as well as conference proceedings for randomized trials presented at scientific conventions, symposia and workshops through August 13, 2013. Hand searches and review of reference lists of retrieved articles were also performed. RESULTS: Five eligible studies were included in the systematic review, of which 4 (382 participants) were pooled in the meta-analysis based on available outcomes data. The overall proportion of cases with resolved incontinence at month 6 was similar in the biofeedback and control groups (OR 1.37 [95% CI 0.64 to 2.93], RD 0.07 [-0.09, 0.23]). There was also no significant difference in mean maximum urinary flow rate (mean difference 0.50 ml, range -0.56 to 1.55) or likelihood of urinary tract infection (OR 1.30 [95% CI 0.65 to 2.58]). CONCLUSIONS: Current evidence does not support the effectiveness of biofeedback in the management of children with nonneuropathic voiding disorders. More high quality, randomized controlled trials are needed to better evaluate the effect of biofeedback.