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Abstract: Background: While opioid substitution treatment (OST) provides the opportunity for substantial improvements in health related quality of life (HRQoL), this relationship is seldom documented and poorly understood. Our objectives were to identify differences in trajectories of HRQoL among chronic opioid-dependent patients and factors associated with improvement and deterioration in HRQoL following enrolment in opioid substitution treatment. Methods: In the North American Opiate Medication Initiative (NAOMI) randomized controlled trial, the Euroqol (EQ-5D) and other measures of demographic, health and drug use characteristics were collected at baseline and quarterly follow-up. Latent class growth analysis was applied to identify classes of HRQoL trajectories during treatment, while baseline correlates of class membership and factors associated with changes in HRQoL were identified in multivariate analyses. Results: Three classes of individual HRQoL growth trajectories were identified: class 1: low and constant (19.5%), class 2: moderate and improved (61.2%), and class 3: high and constant (19.3%). Class 1 members were younger and more likely to be female, while class 3 members were less likely to have chronic conditions and had lower illicit drug use severity at baseline. Changes in HRQoL were associated with improvements in housing status (positive), medical events (negative) and decreases in illicit drug use (positive). Conclusions: Insight into the extent of HRQoL response and characteristics of patients responding to treatment can be used to design interventions that maximize HRQoL improvement. Given its role in economic evaluation and subsequent resource allocation decisions, HRQoL should be considered an endpoint in treatment evaluations for opioid dependence. [Copyright &y& Elsevier]

Abstract: Background: There is consistent evidence showing women access treatment with more severe substance-related profiles relative to men; however, treatment outcome evaluation shows inconclusive results regarding gender differences. Furthermore, few studies evaluate response by gender. Methods: The present analyses were performed using data from the NAOMI study, an open-label, phase III randomized controlled trial, carried out between 2005 and 2008 in Vancouver and Montreal, Canada. A total of 226 long-term treatment-refractory opioid dependent individuals were randomized to receive injectable diacetylmorphine or oral methadone for 12 months. Patients in both treatment groups were offered psychosocial and primary care services. Main outcomes were retention in addiction treatment at 12 months. Drug use, health, psychosocial adjustment and health-related quality of life were examined at baseline and during treatment, using the European Addiction Severity Index, Maudsley Addiction Profile, SF-6D and EuroQol EQ-5D. Results: A total of 88 (38.9%) females and 138 (61.1%) males were included in the present analysis. Retention rates among female participants in the diacetylmorphine group were significantly higher than oral methadone (83.3% vs. 47.8%). Males receiving diacetylmorphine improved significantly more than females in physical health, health-related quality of life, and family relations but female participants in the diacetylmorphine group had significantly greater improvements in illicit drug use scores and psychological health compared to females allocated to oral methadone. Conclusions: Among long-term opioid dependent women who have not benefited sufficiently from available treatments, medically prescribed diacetylmorphine is more effective than oral methadone. Men receiving diacetylmorphine showed more improvements than women. [ABSTRACT FROM AUTHOR]

Abstract: Using data from the North American Opioid Maintenance Initiative study, a Phase III randomized and parallel arm trial, this pilot study is aimed at testing if treatment response with injectable hydromorphone differs compared to diacetylmorphine in the treatment of long-term opioid addiction. A total of 140 long-term, treatment-refractory opioid-dependent individuals received either injectable diacetylmorphine (n = 115) or hydromorphone (n = 25), in a double-blind fashion, over 12 months. At the end of the study, none of the participants in the hydromorphone group thought they were definitely receiving this drug. Retention rates at 12 months with diacetylmorphine (87.8%; 95% confidence interval [CI] = 80.5%–92.7%) and hydromorphone (88.0%; 95% CI = 68.7%–96.1%) were virtually identical. The use of illicit heroin in the prior month declined from a mean of 26.6 and 26.3 days at baseline to 5.3 and 5.2 days at 12 month in the diacetylmorphine and hydromorphone groups, respectively. There were no differences between diacetylmorphine and hydromorphone in the adjusted mean scores of the European Addiction Severity Index. There were no differences in the safety profile of the medications. Hydromorphone may be similarly safe and effective as diacetylmorphine as opioid-agonist substitution treatment; future studies are required to confirm it. Further study will also be required to show that open-label hydromorphone can also successfully attract patients into care and retain them. [Copyright &y& Elsevier]

Background and Aims: Cocaine use is prevalent among people receiving injectable opioid agonist treatment. Investigations of cocaine use in this population have been descriptive and the potential heterogeneity existing in patterns of use have not been characterized. As such, among patients receiving injectable opioid agonist treatment, this study aimed to: 1) quantify intra- and inter-individual variation in cocaine use over 24-months and; 2) determine how predictors of interest explained this variation.Methods: Participants were patients receiving injectable opioid agonist treatment for opioid use disorder. Study visits were completed at baseline prior to receiving treatment, and 3,6,9,12,18, and 24 months after baseline. A multi-level regression approach to growth curve modeling was employed to estimate and explain intra- (within-person) and inter-individual (between-person) variation in cocaine use.Results: Significant intra and inter-individual variation in cocaine use was identified over 24-months. Treatment engagement was on average associated with reductions in the prior month number of days of cocaine use (range: 0-30)(Estimate (standard error): -0.05(0.02), p = 0.003). On average, men reported less cocaine use compared to women (Estimate (standard error): -5.91(1.57), p=<0.001), and participants reporting ever regularly using cocaine at baseline reported more cocaine use over 24-months compared to participants reporting never regularly using cocaine (Estimate (standard error): 4.72 (1.91), p = 0.013).Conclusions: Significant reductions in cocaine use were observed and significant heterogeneity in patterns of cocaine use was identified. These heterogeneous cocaine use profiles suggest that an individualized approach to care will be critical in responding to patients' cocaine use in injectable opioid agonist treatment. [ABSTRACT FROM AUTHOR]

Background: In a double-blind, non-inferiority randomized controlled trial injectable hydromorphone, a licensed short acting opioid analgesic, was shown to be as effective as diacetylmorphine for the treatment of severe opioid use disorder. An appropriate question is whether hydromorphone offered open-label can attract and retain patients.Methods: This is a retrospective study, using daily prescription data from the Crosstown Clinic in Vancouver, Canada. Treatment retention among participants who had the opportunity to receive open-label injectable hydromorphone for at least 90 consecutive days (n = 108) before having the choice of receiving open-label diacetylmorphine, was compared to their retention outcomes with double-blind injectable opioid agonist treatment (iOAT). McNemar tests analyzed differences in proportions; a conditional logistic model estimated exact odds ratios; Pairwise t-tests analyzed differences in total number of treatment days; and Kaplan-Meier curves and clustered log-rank tests compared time to first 30 continuous days without injectable treatment.Results: A total of 74 participants (68.5%) were retained in both open-label hydromorphone and double-blind iOAT. Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10). Participants attended a mean of 84.4 (SD = 15.8) days of iOAT in the trial and 80.5 (SD = 22.0) days in open-label hydromorphone (mean difference of -3.9; 95% CI = -8.9, 1.1). Kaplan-Meier curves and log-rank tests were not statistically significant.Conclusion: As treatment with injectable hydromorphone expands across Canada, our study contributes in a unique manner by providing evidence that the high retention rates observed during the clinical trial were maintained when participants started open-label hydromorphone. [ABSTRACT FROM AUTHOR]

Aims To investigate baseline and concurrent predictors of non-use of illicit heroin among participants randomized to injectable opioids in the North American Opiate Medication Initiative (NAOMI) clinical trial. Methods NAOMI was an open-label randomized controlled trial comparing the effectiveness of injectable diacetylmorphine and hydromorphone for long-term opioid-dependency. Outcomes were assessed at baseline and during treatment (3, 6, 9, 12 months). Days of non-use of illicit heroin in the prior month at each follow-up visit were divided into three categories: Non-use; Low use (1 to 7 days) and High use (8 days or more). Tested covariates were: Sociodemographics, Health, Treatment, Drug use and illegal activities. Mixed-effect proportional odds models with random intercept for longitudinal ordinal outcomes were used to assess the predictors of the non-use of illicit heroin. Results 139 participants were included in the present analysis. At each follow-up visit, those with non-use of illicit heroin represented 47.5% to 54.0% of the sample. Fewer days of cocaine use (p = 0.074), fewer days engaged in illegal activities at baseline (p < 0.01) and at each visit (p < 0.01), less money spent on drugs (p < 0.001), days with injection opioid or oral methadone treatment (p < 0.001) and total mg of injectable opioids taken (p < 0.001), independently predicted lower use of illicit heroin. Conclusions The independent effect of several concurrent factors besides the injection of opioid dose suggests benefits from the clinic that go beyond the provision of the medication alone. Thus, this supervised model of care presents an opportunity to maximize the beneficial impact of medical and psychosocial components of the treatment on improving outcomes associated with non-use of illicit heroin. [ABSTRACT FROM AUTHOR]

Abstract: Opioid-dependent individuals with a history of abuse have exhibited worse mental and physical health compared to those without such a history; however, the evidence regarding the influence of abuse histories on addiction treatment outcomes are conflicting. In the present study, we identified history of physical or sexual abuse at treatment initiation in relation to drug use and health among long-term opioid-dependent individuals and we determined the relationship of abuse histories with treatment outcomes following substitution treatment. We analyzed data from a randomized controlled trial that compared the effectiveness of opioid-agonists in the treatment of chronic opioid dependence. The North American Opiate Medication Initiative (NAOMI) was conducted in Vancouver and Montreal (Canada) and provided oral methadone, injectable diacetylmorphine or injectable hydromorphone, the last two on a double blind basis, over 12months. A total of 112 (44.6%) participants reported a history of physical or sexual abuse at baseline. Participants with an abuse history reported a significantly higher number of chronic medical problems, suicide attempts, and previous drug treatments and had poorer psychiatric, family and social relations, and quality of life status compared to those without abuse histories. No differences in current and past substance use were found between those with and without abuse histories. Following 12months of treatment, the participants with abuse histories improved to a similar degree as those without a history of abuse in all of the European Addiction Severity Index sub-scales, with the exception of medical status. The findings suggest that individuals with abuse histories were able to achieve similar outcomes as those without abuse histories following treatment despite having poorer scores in physical and mental health, social status and quality of life at treatment initiation. These findings suggest that the substitution treatments as provided in this study can benefit the most vulnerable and access needs to be expanded to reach this population. [Copyright &y& Elsevier]

Abstract: Objective: To provide a comparative analysis of the psychometric properties of eight measures of health status among chronic opioid-dependent patients. Study Design and Setting: Longitudinal data were analyzed for 251 patients enrolled in the North American Opiate Medication Initiative randomized controlled trial, conducted in Vancouver, British Columbia and Montreal, Quebec, Canada. Content validity, evidence of floor and ceiling effects, internal consistency, construct validity, and responsiveness were assessed for the Addiction Severity Index (ASI) medical and psychiatric (ASImed and ASIpsych) composite scores, the Maudesley Addiction Profile (MAP) physical and mental health scores (MAP-physical health score [MAP-PHS], MAP-mental health score [MAP-MHS]), the World Health Organization Disability Assessment Schedule-II, the EuroQol Group''s EQ-5D index score and visual analog scale, EuroQol visual analog scale (EQ-VAS), and the Short Form SF-6D index score. Results: ASImed was best able to discriminate among patients with and without chronic conditions. The MAP-PHS and MAP-MHS were not unidimensional. ASImed and ASIpsych had prominent ceiling effects. ASImed, MAP-MHS, MAP–PHS, EQ-VAS, and EQ-5D were all responsive to decreases in illicit drug use. Conclusion: None of the instruments performed uniformly as “best” or “worst.” The EQ-5D appeared to be the preferable generic, indirect utility measure. Our results provide an evidence base to inform selection and further development of health status measures in opioid-dependent populations. [Copyright &y& Elsevier]

Abstract: Dropout and recidivism from addiction treatment has been found to be associated with individuals’ readiness for change. Motivation for treatment among participants entering the North American Opiate Medication Initiative (NAOMI) randomized controlled trial, which compared heroin assisted treatment (HAT) to optimized methadone maintenance treatment (MMT), was assessed. Through multivariate regression, we aimed to determine whether baseline motivational status was predictive of four treatment outcomes: early dropout, 12-month retention, 12-month response to treatment, and time to discontinuation of treatment. Among the 251 out-of-treatment chronic opioid dependent patients recruited in Montreal, Quebec and Vancouver, British Columbia, 52% reported having a high level of motivation for treatment. HAT was statistically significantly more effective than MMT on each of the outcomes assessed. Baseline motivational status did not predict retention or time to discontinuation in either HAT or MMT. However, while patients were retained in HAT regardless of motivational status, motivated patients showed a more favourable response to treatment in terms of decreases in crime and illicit drug use. These results suggest that HAT successfully retains opioid dependent patients who otherwise may not have been attracted into existing treatment options, and may enhance the odds of successful rehabilitation among patients motivated for treatment. [ABSTRACT FROM AUTHOR]

Background: Patients' perceptions are vital to the delivery and evaluation of substance use treatment. They are most frequently collected at one time-point and measured using patient satisfaction questionnaires or qualitative methodologies. Interestingly, the findings of these studies often diverge, as satisfaction scores tend to be highly positive, while qualitative findings suggest dissatisfaction and areas for improvement. This divergence limits current understandings of patients' perceptions and their potential change over time in treatment.Objective: This study explores the relationship between open-ended positive and negative perceptions of treatment and patient satisfaction scores over time.Methods: The RUTH (Research on the Utilization of Therapeutic Hydromorphone) prospective cohort study included 131 participants receiving injectable diacetylmorphine or hydromorphone in Canada's first injectable opioid agonist treatment (iOAT) program. The study collected the Client Satisfaction Questionnaire (CSQ-8) at eight time-points over an 18-month period. Following a multi-methods approach, the study complemented the CSQ-8 with open-ended positive and negative comments of iOAT. The research team analyzed these comments thematically at each time-point to develop positive and negative perception themes. We then used growth curve modeling to explore the relationship between positive and negative perception themes and patient satisfaction over time.Findings: Over the eight time-points, six positive and eight negative perception themes emerged, broadly reflecting structural (e.g., expansion of iOAT), process (e.g., schedules), relational (e.g., interactions with providers), and outcome-related (e.g., met/unmet needs) perceptions of iOAT. On average, participants reported high satisfaction (grand mean = 29.2 out of 32), and scores did not significantly change over time. However, we did find significant unexplained variation within participants in their satisfaction trajectories and between participants in their initial satisfaction scores. In conditional growth curve models, the theme "unfavorable interactions with providers" had the strongest independent effect on overall satisfaction trajectories.Conclusions: This study provides an example of how open-ended comments can be integrated with patient satisfaction questionnaire data to gather a comprehensive and patient-centered evaluation of substance use treatment. Considering the iOAT context specifically, relational dynamics and daily treatment access were significant predictors of patient satisfaction over time and may be attributes of iOAT that require further investigation. [ABSTRACT FROM AUTHOR]

Aims: To review the safety profile of injectable hydromorphone and diacetylmorphine and explore if adverse events (AEs) or serious adverse events (SAEs) were associated with dose and patterns of attendance.Methods: This was a non-inferiority randomized double-blind controlled trial (Vancouver, Canada) testing hydromorphone (n=100) and diacetylmorphine (n=102) for the treatment of severe opioid use disorder. Medications were delivered under the supervision of trained Registered Nurses up to three times daily. AEs were described using MedDRA codes.Results: Most common related AEs included immediate post-injection reaction or injection site pruritus reactions, somnolence and opioid overdoses. Adjusted analysis indicated that participants in the hydromorphone group were less likely to have any related AE or SAE compared to the diacetylmorphine group. Related somnolence and opioid overdose events were distributed throughout the six months treatment period. In the diacetylmorphine group, five of the eleven related SAE opioid overdoses (requiring naloxone) occurred in the first 30days since most recent treatment initiation. Analysis of somnolence and opioid overdose (AEs and SAEs) event rates by received dose suggested a non-linear relationship. However, in the diacetylmorphine group higher event rates per person days were recorded at lower doses.Conclusions: When injectable hydromorphone and diacetylmorphine are individually dosed and monitored, their opioid-related side effects, including potential fatal overdoses, are safely mitigated and treated by health care providers. In the midst of an opioid overdose epidemic, injectable options are timely to reach a very important minority of people who inject street opioids and are not attracted to other treatments. [ABSTRACT FROM AUTHOR]

Purpose: A recent randomized clinical trial has demonstrated that direct decompressive surgery plus radiotherapy was superior to radiotherapy alone for the treatment of metastatic epidural spinal cord compression. The current study compared the cost-effectiveness of the two approaches. Methods and Materials: In the original clinical trial, clinical effectiveness was measured by ambulation and survival time until death. In this study, an incremental cost-effectiveness analysis was performed from a societal perspective. Costs related to treatment and posttreatment care were estimated and extended to the lifetime of the cohort. Weibull regression was applied to extrapolate outcomes in the presence of censored clinical effectiveness data. Results: From a societal perspective, the baseline incremental cost-effectiveness ratio (ICER) was found to be $60 per additional day of ambulation (all costs in 2003 Canadian dollars). Using probabilistic sensitivity analysis, 50% of all generated ICERs were lower than $57, and 95% were lower than $242 per additional day of ambulation. This analysis had a 95% CI of −$72.74 to 309.44, meaning that this intervention ranged from a financial savings of $72.74 to a cost of $309.44 per additional day of ambulation. Using survival as the measure of effectiveness resulted in an ICER of $30,940 per life-year gained. Conclusions: We found strong evidence that treatment of metastatic epidural spinal cord compression with surgery in addition to radiotherapy is cost-effective both in terms of cost per additional day of ambulation, and cost per life-year gained. [Copyright &y& Elsevier]