Opioid Agonist Treatment Programs Research Articles

A multi-methods and longitudinal study of patients' perceptions in injectable opioid agonist treatment: Implications for advancing patient-centered methodologies in substance use research

BackgroundPatients' 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. ObjectiveThis study explores the relationship between open-ended positive and negative perceptions of treatment and patient satisfaction scores over time. MethodsThe 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. FindingsOver 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. ConclusionsThis 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.

Methadone and buprenorphine treatment in United States jails and prisons: lessons from early adopters.

To identify implementation barriers and facilitators to the adoption and implementation of programs that provide opioid agonist treatments (OAT) with methadone and buprenorphine to treat opioid use disorder in jails and prisons in the United States. Qualitative analysis: semi-structured interviews were conducted and thematic analyses of transcripts and notes were performed using a hybrid inductive/deductive coding approach. Jails and prisons in the United States. From August 2019 to January 2020, we conducted 20 key informant interviews with 35 individuals representing 19 carceral systems that both initiate and maintain OAT. Interviews covered four domains: (1) program adoption; (2) policy influence on implementation; (3) program structure; and (4) program outcomes. Stigma among staff, particularly medical staff, challenged program adoption, but reduced over time as staff were exposed to the program. Regulations on OAT dispensation, such as licensing requirements and prescribing limits, were key challenges to program implementation and shaped program structure. Dispensing medication required significant staff, time and space. Facilities were further challenged to overcome stigma and concerns about diversion, as OAT medication is often treated as contraband in carceral settings. Some systems deviated from evidence-based treatment by limiting OAT dosage to low levels, requiring counseling for participation and requiring detoxification before medication initiation. Despite these challenges, early adopters felt strongly that other jails and prisons in the United States should provide OAT and that legislation and litigation may soon force OAT expansion in these carceral settings. Despite identifying regulatory and logistical challenges, early adopters of opioid agonist treatment (OAT) programs in US jails and prisons demonstrate that OAT programs can successfully be implemented in carceral settings with tailoring to the specific context.

Rapid transitional response to the COVID-19 pandemic by opioid agonist treatment programs in Ukraine

On March 16, 2020, Ukraine's Ministry of Health issued nonspecific interim guidance to continue enrolling patients in opioid agonist therapies (OAT) and transition existing patients to take-home dosing to reduce community COVID-19 transmission. Though the number of OAT patients increased modestly, the proportion receiving take-home dosing increased from 57.5% to 82.2%, which translates on average to 963,952 fewer clinic interactions annually (range: 728,652–1,016,895) and potentially 80,329 (range: 60,721–84,741) fewer hours of in-person clinical encounters. During the transition, narcologists (addiction specialists) expressed concerns about overdoses, the guidance contradicting existing legislation, and patient dropout, either from incarceration or inadequate public transportation. Though clinicians did observe some overdoses, short-term overall mortality remained similar to the previous year. As the country relaxes the interim guidance, we do not know to what extent governmental guidance or clinical practice will change to adopt the new guidance permanently or revert to pre-guidance regulations. Some future considerations that have come from COVID-19 are should dosing schedules continue to be flexible, should clinicians adopt telehealth, and should there be more overdose education and naloxone distribution? OAT delivery has improved and become more efficient, but clinicians should plan long-term should COVID-19 return in the near future. If the new efficiencies are maintained, it will free the workforce to further scale up OAT.

Early Effects of COVID-19 on Programs Providing Medications for Opioid Use Disorder in Jails and Prisons.

To describe how the novel coronavirus (COVID-19) pandemic has affected opioid agonist treatment (OAT) programs in jails and prisons. In May 2020, we conducted an online survey of 19 carceral systems that provided methadone and/or buprenorphine treatment for incarcerated populations before COVID-19. Eleven survey items examined challenges and changes to these programs as a result of the pandemic. Sixteen of 19 programs (84%) responded to the survey. Ten out of 16 systems reported downsizing their OAT programs. Seven of 16 systems made changes to medication dispensation processes. Half of systems report challenges implementing physical distancing (n = 8), and/or obtaining personal protective equipment (n = 8). In 13 out of 16 systems some OAT program participants were released early due to COVID-19 infection risk. Jails and prisons with existing OAT programs have curtailed their operations in the context of the COVID-19 pandemic. Given the robust evidence base around OAT for treating opioid use disorder and averting overdose deaths, guidance is needed on maintaining and ramping up medication access as carceral facilities grapple with implementing COVID-19 mitigation.

IOAT in the ED – Lessons Learned

Emergency Strategic Clinical NetworkTM 
 Quality and Innovation Forum Presentation Proposal
 Name: xx
 Position (e.g. patient care manager, professor): Manager
 Primary Affiliation: (AHS) Other: AHS
 Project Title: iOAT in the ED – Lessons Learned
 Hospital: All adult sites in Calgary 
 Location: Calgary
 Team Members: xx & xx
 Background
 Deaths related to opioid poisoning have continued to climb over the last few years. The Injectable Opioid Agonist Treatment program (iOAT) provides injectable hydromorphone to those individuals with moderate to severe opioid use disorder and a history of injection drug use who have been unsuccessful with oral OAT and continue to be at high risk for opioid poisoning. Working with the emergency departments (ED) was identified as a critical step in the initial roll out of iOAT.
 Implementation 
 The iOAT program began operating in October 2018. The clinic provides prescribed hydromorphone to clients within the program. Additionally, the team is comprised of physicians, nurse practitioners, nurses, social worker, peer support workers and administrative support to provide comprehensive wrap around care to every client that is registered to the program. It was recognized early on that the clients that were being served by iOAT were also high users of the ED and UCCs. Being part of iOAT became a factor that needed to be considered when these clients presented to the ED due to their prescription of hydromorphone. Working with management, medical leadership, and nurse educators, support and education were provided to ensure that iOAT clients were provided with optimal care when in the ED. Ongoing communication has been the primary strategy that has been used.
 Evaluation Methods 
 The evaluation for this project has been informal and ongoing. The medical team at iOAT has worked with the medical team for the Calgary EDs to develop a detailed treatment plan that is visible on SCM. Telephone and emails have been the primary mode of feedback for both parties, and the plan is adjusted as necessary along the way.
 Results
 Improving the knowledge and understanding for all staff involved to understand iOAT and the role of the ED has been demonstrated to be effective when clients stay in the ED and don’t leave against medical advice, which likely occurred before. Additionally, the trust that is built within the iOAT clinic is maintained when the ED is a partner in care and as appropriate, provides them with the dosing that they would normally receive at iOAT.
 Advice and Lessons Learned 
 1) Involve the emergency department management in planning or initial implementation
 2) Communicate, Communicate, Communicate
 3) Use continuous feedback to adjust to find the best strategies to provide patient care

Global opioid agonist treatment: a review of clinical practices by country.

We assessed how opioid agonist treatment (OAT) for opioid use disorder (OUD), specifically methadone and buprenorphine, including buprenorphine-naloxone, is delivered in routine clinical practice, with a focus on factors that affect access to and delivery of these services. The aims of this review were to summarize eligibility criteria for entry to OAT, doses in routine clinical practice, access to and eligibility for unsupervised dosing and urine drug screening practices in OAT programs globally. We completed searches of PubMed, Embase, and grey literature databases for cross-sectional or observational cohort studies of OAT using either methadone or buprenorphine. Dose data extracted from eligible studies were compared with guidelines provided by WHO. We found 140 reports from 41 countries that contained data for at least one of the relevant indicators. A diagnosis of opioid dependence or opioid use disorder was the most common eligibility requirement for OAT (13 or 17 countries). Reported mean or median doses for methadone ranged from 16-131mg whereas range for buprenorphine was 2.5-19mg. Access to unsupervised dosing under some conditions was reported in 18 of 27 countries. Frequency of regular urine drug screenings (UDS) ranged from several times a week to eight times per year (methadone) or as clinically indicated. Opioid agonist treatment practices, including doses prescribed, vary greatly both within and across countries. Of particular concern is the persistence of lower dose prescribing practices, in which patients may be prescribed doses below those proven to yield significant clinical benefits.

Postoperative opioid misuse in patients with opioid use disorders maintained on opioid agonist treatment

BackgroundPatients recovering from opioid use disorders (OUD) may be prone to relapse and opioid misuse in the postoperative period due to re-exposure to prescription opioids for pain control. This retrospective study analyzed the incidence of confirmed opioid misuse in the postoperative period in patients with OUDs enrolled in an opioid agonist treatment (OAT) program. MethodsThe study population was US veterans with a diagnosis of OUD who enrolled in the OAT program at VA Maryland Health Care System (Baltimore, Maryland, USA) between 1/1/2000 and 12/31/2016. The patients were excluded if they were enrolled in OAT for less than a year, or if they had surgery within the first 180 days after OAT admission. The surgical group consisted of veterans who had surgery or an invasive procedure during their enrollment in the OAT program. The control (reference) group consisted of enrolled veterans who did not have any invasive procedure. The primary outcome was the first opioid misuse within 365 days after surgery date in the surgical group or a randomly assigned sham surgery date in controls. Opioid misuse was defined as either inappropriate use of opioids detected via urinalysis or admission with a diagnosis of an opioid overdose. ResultsFrom a total of 1352 patients enrolled in the OAT program, 413 were excluded because they were enrolled for less than a year, and 26 were excluded because they had surgery within the first 180 days after admission to the OAT program. Of the 923 eligible patients, 87 had surgery while enrolled and 836 did not. Using propensity scores, all 87 of the surgical cases were matched to 249 of the control cases. In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05–3.48, p = 0.034) in logistic regression. ConclusionAmong patients with a history of opioid use disorders, the postoperative period was associated with an increased risk of opioid misuse. Moreover, opioid misuse among patients in an opioid agonist treatment program may well be considered a surgical hazard.

Receipt of opioid agonist treatment halves the risk of HIV-1 RNA viral load rebound through improved ART adherence for HIV-infected women who use illicit drugs

BackgroundWomen living with HIV who use illicit drugs may be particularly vulnerable to HIV-1 RNA viral load (VL) rebound. MethodsWe used longitudinal data from 2006 to 2017 to evaluate the impact of sociodemographic, behavioral, social-structural, and clinical factors on the hazard of viral rebound for women enrolled in the ACCESS study, a prospective cohort with systematic VL monitoring. Women were included if they achieved VL suppression (<50 copies/mL) following antiretroviral therapy (ART) initiation and had more than one study interview. Sociodemographic as well as substance use, social-structural, addiction treatment, and HIV clinical factors were evaluated as predictors of viral rebound (VL > 1000 copies/mL). Cox regressions using a recurrent events framework, time-varying covariates, robust standard errors, and a frailty component were used. ResultsOf the 185 women included, 62 (34%) experienced at least one viral rebound event over an 11-year period, accumulating a total of 87 viral rebound events. In adjusted analysis, stimulant use more than doubled the hazard of viral rebound (adjusted hazard ratio [AHR]: 2.35, 95% confidence interval [CI]: 1.07–5.14) while the only factor protective against viral rebound was receipt of opioid agonist treatment (OAT) in the past six months (AHR: 0.46, 95% CI: 0.26–0.81). After adjusting for ART adherence in the past six months, the effect of OAT was attenuated (AHR: 0.57, 95% CI: 0.32–1.02). ConclusionsEfforts to improve access to and retention within OAT programs and decrease stimulant use may improve rates of viral suppression for HIV-positive women who use illicit drugs.

A pilot study assessing acceptability and feasibility of hatha yoga for chronic pain in people receiving opioid agonist therapy for opioid use disorder

The purpose of this project was to assess the feasibility and acceptability of a hatha yoga program designed to target chronic pain in people receiving opioid agonist therapy for opioid use disorder. We conducted a pilot randomized trial in which people with chronic pain who were receiving either methadone maintenance therapy (n = 20) or buprenorphine (n = 20) were randomly assigned to weekly hatha yoga or health education (HE) classes for 3 months. We demonstrated feasibility in many domains, including recruitment of participants (58% female, mean age 43), retention for follow-up assessments, and ability of teachers to provide interventions with high fidelity to the manuals. Fifty percent of participants in yoga (95% CI: 0.28–0.72) and 65% of participants in HE (95% CI: 0.44–0.87) attended at least 6 of 12 possible classes (p = 0.62). Sixty-one percent in the yoga group reported practicing yoga at home, with a mean number of times practicing per week of 2.67 (SD = 2.37). Participant mood improved pre-class to post-class, with greater decreases in anxiety and pain for those in the yoga group (p < 0.05). In conclusion, yoga can be delivered on-site at opioid agonist treatment programs with home practice taken up by the majority of participants. Future research may explore ways of increasing the yoga “dosage” received. This may involve testing strategies for increasing either class attendance or the amount of home practice or both.

Injection risk norms and practices among migrant Puerto Rican people who inject drugs in New York City: The limits of acculturation theory

BackgroundAmong people who inject drugs (PWID) in New York City (NYC), racial minorities are disproportionately infected with HIV and hepatitis C (HCV). Prior research has shown that PWID who started injecting drugs in Puerto Rico (P.R.) tend to maintain the risky injection behaviors learned there. This study identifies the P.R.-native norms supporting the continued injection risk behavior of migrant Puerto Rican PWID in NYC to inform a culturally appropriate risk-reduction intervention. Methods40 migrant Puerto Rican PWID were recruited in NYC for a longitudinal qualitative study. The sample was stratified to include 20 migrants with <3 years in NYC and 20 migrants with >3-6 years in NYC. Time-location sampling was used to curb possible network bias in recruitment. Over 12 months, migrants completed semi-structured interviews at baseline, monthly follow-ups, and study exit. Analyses were guided by grounded theory. ResultsMost participants (90%) reported having had chronic HCV, and 22.5% reported being HIV-positive. Syringe- and cooker-/cotton-sharing were widespread in both P.R. and NYC. The ubiquitous practice of cleaning used syringes by “water-rinsing and air-blowing” was guided by a normative belief, learned in P.R., that “water and air kill HIV.” Sterile syringe use was not a priority. HCV was not a concern. P.R.-native abstinence-only narratives discouraged opioid agonist treatment (OAT) enrollment among recent migrants (≤3 years). Experiences with drug dealers, prison-power groups, and injection doctors (“Gancheros”) in P.R. influenced migrants’ injection risk behavior in NYC. Those who were Gancheros in P.R. continued working as Gancheros in NYC. ConclusionsInjection risks make migrant Puerto Rican PWID in NYC vulnerable to HIV/HCV. Harm reduction programs should pay closer attention to the rationales behind these injection risks. A risk-reduction intervention that incorporates the Ganchero figure may be a credible way to help migrants reduce injection risk and accept OAT and syringe exchange programs (SEP).

Cost-effectiveness of Hepatitis C Virus Treatment Models for People Who Inject Drugs in Opioid Agonist Treatment Programs.

Many people who inject drugs in the United States have chronic hepatitis C virus (HCV). On-site treatment in opiate agonist treatment (OAT) programs addresses HCV treatment barriers, but few evidence-based models exist. We evaluated the cost-effectiveness of HCV treatment models for OAT patients using data from a randomized trial conducted in Bronx, New York. We used a decision analytic model to compare self-administered individual treatment (SIT), group treatment (GT), directly observed therapy (DOT), and no intervention for a simulated cohort with the same demographic characteristics of trial participants. We projected long-term outcomes using an established model of HCV disease progression and treatment (hepatitis C cost-effectiveness model: HEP-CE). Incremental cost-effectiveness ratios (ICERs) are reported in 2016 US$/quality-adjusted life years (QALY), discounted 3% annually, from the healthcare sector and societal perspectives. For those assigned to SIT, we projected 89% would ever achieve a sustained viral response (SVR), with 7.21 QALYs and a $245 500 lifetime cost, compared to 22% achieving SVR, with 5.49 QALYs and a $161 300 lifetime cost, with no intervention. GT was more efficient than SIT, resulting in 0.33 additional QALYs and a $14 100 lower lifetime cost per person, with an ICER of $34 300/QALY, compared to no intervention. DOT was slightly more effective and costly than GT, with an ICER > $100 000/QALY, compared to GT. In probabilistic sensitivity analyses, GT and DOT were preferred in 91% of simulations at a threshold of <$100 000/QALY; conclusions were similar from the societal perspective. All models were associated with high rates of achieving SVR, compared to standard care. GT and DOT treatment models should be considered as cost-effective alternatives to SIT.

Feasibility and acceptability of adherence support for direct acting antiviral therapy for hepatitis C in a low-threshold primary health-care opioid agonist treatment program.

To maximise the benefits of direct acting antivirals in Australia, innovative options for marginalised populations to receive daily or weekly medication may be beneficial. This study evaluated the feasibility and acceptability of direct acting antivirals provision by leveraging an opioid agonist treatment program to support adherence regardless of opioid agonist treatment enrolment. Feasibility was evaluated by monitoring selection of dosing options by clients initiating direct acting antivirals during the first 6 months. Client acceptability was assessed using a cross-sectional survey after 6 months. Pre- and post-implementation surveys of attitudes and concerns regarding the program were compared to evaluate staff acceptability. Among 79 clients commencing direct acting antivirals, 30 (38%) chose adherence support. Among these, 12 (40%) were not simultaneously enrolled in opioid agonist treatment. Clients were satisfied with service provision and access despite introducing daily dosing. All highly marginalised clients receiving direct acting antivirals with adherence support found this helpful. Staff concerns identified prior to the program proved unfounded. This study demonstrates providing adherence support for direct acting antivirals regardless of client participation in opioid agonist treatment is both feasible and acceptable with minimal impact on service provision. Availability of direct acting antivirals in opioid agonist treatment or primary health-care settings expands the pool of people who may receive effective treatment for hepatitis C virus and reduces treatment barriers.

White matter structural connectivity abnormalities in subjects with deficit schizophrenia: A diffusion tensor imaging study

Women living with HIV who use illicit drugs may be particularly vulnerable to HIV-1 RNA viral load (VL) rebound.We used longitudinal data from 2006 to 2017 to evaluate the impact of sociodemographic, behavioral, social-structural, and clinical factors on the hazard of viral rebound for women enrolled in the ACCESS study, a prospective cohort with systematic VL monitoring. Women were included if they achieved VL suppression (<50 copies/mL) following antiretroviral therapy (ART) initiation and had more than one study interview. Sociodemographic as well as substance use, social-structural, addiction treatment, and HIV clinical factors were evaluated as predictors of viral rebound (VL > 1000 copies/mL). Cox regressions using a recurrent events framework, time-varying covariates, robust standard errors, and a frailty component were used.Of the 185 women included, 62 (34%) experienced at least one viral rebound event over an 11-year period, accumulating a total of 87 viral rebound events. In adjusted analysis, stimulant use more than doubled the hazard of viral rebound (adjusted hazard ratio [AHR]: 2.35, 95% confidence interval [CI]: 1.07–5.14) while the only factor protective against viral rebound was receipt of opioid agonist treatment (OAT) in the past six months (AHR: 0.46, 95% CI: 0.26–0.81). After adjusting for ART adherence in the past six months, the effect of OAT was attenuated (AHR: 0.57, 95% CI: 0.32–1.02).Efforts to improve access to and retention within OAT programs and decrease stimulant use may improve rates of viral suppression for HIV-positive women who use illicit drugs.

Direct-acting antiviral therapy for hepatitis C infection among people receiving opioid agonist treatment or heroin assisted treatment

BackgroundTreating chronic hepatitis C virus (HCV) infection among PWID (people who inject drugs) is crucial to achieve the WHO goal of HCV elimination, as this population is highly affected and carries a high risk of transmission.The aim of our study was to provide real-life data on HCV treatment among PWID either in opioid agonist treatment (OAT) or in heroin-assisted treatment (HAT) in a low-threshold access primary care-based addiction medicine institution. MethodsWe conducted a retrospective chart analysis of patients treated with direct-acting antivirals (DAA) between 10/2014 and 08/2017 in the Arud outpatient clinics in Zurich, Switzerland. We reported patient and treatment characteristics and substance use. The outcomes were sustained virological response (SVR) by intention-to-treat (ITT) and modified ITT (mITT) analyses, excluding patients with missing SVR data. ResultsWe included 64 patients in our analysis. Forty-two (66%) were in OAT, and 22 (34%) were in HAT. Twenty-six patients (41%) reported harmful alcohol use, and 9 patients (14%) reported injecting drug use during DAA treatment. Every patient completed the treatment. Fifty-nine out of 64 achieved SVR resulting in an ITT SVR rate of 92.2%. Two patients had virological failure. Three patients were lost to follow-up between the end of treatment and SVR12 visit. Excluding these 3 patients, our study showed an mITT SVR rate of 96.7%. ConclusionPWID can be treated with DAA treatment integrated in OAT and HAT with an excellent SVR rate. OAT and HAT programs should offer integrated HCV treatment to their patients.

Physician prescribing of opioid agonist treatments in provincial correctional facilities in Ontario, Canada: A survey.

BackgroundSubstance use and substance use disorders are common in people who experience detention or incarceration in Canada, and opioid agonist treatment (OAT) may reduce the harms associated with substance use disorders. We aimed to define current physician practice in provincial correctional facilities in Ontario with respect to prescribing OAT and to identify potential barriers and facilitators to prescribing OAT.MethodsWe invited all physicians practicing in the 26 provincial correctional facilities for adults in Ontario to participate in an online survey.ResultsTwenty-seven physicians participated, with representation from most correctional facilities in Ontario. Of participating physicians, 52% reported prescribing methadone and 48% reported prescribing buprenorphine/naloxone to patients in provincial correctional facilities. Nineteen percent of participants reported initiating methadone treatment and 11% reported initiating buprenorphine/naloxone for patients in custody. Participants identified multiple barriers to initiating OAT in provincial correctional facilities including concerns about medication diversion and safety, concerns about initiating treatment in patients who are not currently using opioids, lack of linkage with community-based providers and the Ministry of Community Safety and Correctional Services policy. Identified facilitators to initiating OAT were support from institutional health care staff and administrative staff, adequate resources for program delivery and access to linkage with community-based OAT providers.ConclusionsThis study identifies opportunities to improve OAT programs and to improve access to OAT for persons in provincial correctional facilities in Ontario.

Rationale, design, and methodology of a trial evaluating three models of care for HCV treatment among injection drug users on opioid agonist therapy

BackgroundPeople who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York.Methods/designIn this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control – self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness.DiscussionThis paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack technology will help us determine the role of adherence in successful cure of HCV. Moreover, the trial methodology outlined here can serve as a template for the development of future programs and studies among HCV-infected drug users receiving opioid agonist therapy, as well as the cost-effectiveness of such programs.Trial registrationThis trial was registered with ClinicalTrials.gov (NCT01857245). Trial registration was obtained prospectively on May 20th, 2013.

Concurrent drug injection during opioid agonist treatment among people who inject drugs in Ukraine

Ongoing drug use during opioid agonist treatment (OAT) negatively affects treatment and health outcomes, and increases treatment dropout. This study aimed to examine correlates of concurrent illicit drug use among OAT patients in Ukraine. A random sample of 434 patients currently on OAT receiving buprenorphine (BMT) or methadone maintenance treatment (MMT) from five cities in Ukraine were assessed for factors associated with self-reported concurrent illicit drug use during OAT using a multivariable logistic regression. Among 434 OAT patients, 100 (23%) reported concurrent drug injecting in the previous 30 days; 28% of these were injecting ≥20 days. While 100 (100%) of these injected opioids, 24 (24%) injected stimulants; 40 (40%) met criteria for polysubstance use disorder that included opioids, stimulants and alcohol. Independent correlates of concurrent drug injection included: being on MMT vs. BMT (aOR = 2.8, 95%CI = 1.4–5.8), lower OAT dosage (aOR = 1.7, 95%CI = 1.1–2.7), more severe addiction severity (aOR = 2.3, 95%CI = 1.4–3.8), younger age of injection initiation (aOR = 2.3, 95%CI = 1.3–3.9), and presence of alcohol use disorder (aOR = 2.1, 95%CI = 1.3–3.5); participants living with parents were negatively associated with concurrent drug injection. Concurrent drug use was prevalent among OAT patients in Ukraine indicating the urgent needs for tailored interventions and changes in OAT program design and implementation. Results highlight the importance of prescribing an adequate OAT dosage, and discrepancies between MMT and BMT programs in Ukraine addressing needs of OAT patients with specific characteristics such as severe opioid and alcohol dependence.

An evidence-based recommendation to increase the dosing frequency of buprenorphine during pregnancy

Dose-adjusted plasma concentrations of buprenorphine are significantly decreased during pregnancy compared with the nonpregnant state. This observation suggests that pregnant women may need a higher dose of buprenorphine than nonpregnant individuals to maintain similar drug exposure (plasma concentrations over time after a dose). The current dosing recommendations for buprenorphine during pregnancy address the total daily dose of buprenorphine to be administered, but the frequency of dosing is not clearly addressed. Based on buprenorphine's long terminal half-life, once-daily or twice-daily dosing has generally been suggested. The objective of the study was to assess the impact of dosing frequency on buprenorphine plasma concentration time course during pregnancy. We utilized 3 data sources to determine an optimal frequency for dosing of buprenorphine during pregnancy: data from a pharmacokinetic study of 14 pregnant and postpartum women on maintenance buprenorphine in a supervised clinical setting; data from pregnant women attending a buprenorphine clinic; and data from a physiologically based pharmacokinetic modeling of buprenorphine pharmacokinetics in nonpregnant subjects. Among the 14 women participating in the pharmacokinetic study during and after pregnancy, plasma concentrations of buprenorphine were <1 ng/mL (the theoretical concentration required to prevent withdrawal symptoms) for 50-80% of the 12 hour dosing interval while at steady state. Among 62 women followed up in a opioid agonist treatment program, in which dosing frequency is determined in part by patient preference, 10 (16%) were on once-daily dosing, 10 (16%) were on twice-daily dosing, 28 (45%) were on thrice-daily dosing, and 14 (23%) were on four-times-daily dosing. A physiologically based pharmacokinetic model in nonpregnant subjects demonstrated that dosing frequency has an impact on the duration over which the plasma concentrations are below a specified plasma concentration threshold. A more frequent dosing interval (ie, three-times-daily or four-times-daily dosing) may be required in pregnant women to sustain plasma concentrations above the threshold of 1 ng/mL to prevent withdrawal symptoms and to improve adherence.

Integrated telemedicine-based treatment for hepatitis C at an opioid agonist treatment program

Integrated telemedicine-based treatment for hepatitis C at an opioid agonist treatment program

The Role of Program Directors in Treatment Practices: The Case of Methadone Dose Patterns in U.S. Outpatient Opioid Agonist Treatment Programs.

To describe changes in characteristics of directors of outpatient opioid agonist treatment (OAT) programs, and to examine the association between directors' characteristics and low methadone dosage. Repeated cross-sectional surveys of OAT programs in the United States from 1995 to 2011. We used generalized linear regression models to examine associations between directors' characteristics and methadone dose, adjusting for program and patient factors. Data were collected through telephone surveys of program directors. The proportion of OAT programs with an African American director declined over time, from 29 percent in 1995 to 16 percent in 2011. The median percentage of patients in each program receiving <60mg/day declined significantly, from 48.5 percent in 1995 to 29 percent in 2005 and 23 percent in 2011. Programs with an African American director were significantly more likely to provide low methadone doses than other programs. This association was even stronger in programs with an African American director who served populations with higher percentages of African American patients. Demographic characteristics of OAT program directors (e.g., their race) may play a key role in explaining variations in methadone dosage across programs and patients. Further research should investigate the causal pathways through which directors' characteristics affect treatment practices. This may lead to new, multifaceted managerial interventions to improve patient outcomes.