Dataset Information

Technology-assisted methadone take-home dosing for dispensing methadone to persons with opioid use disorder during the Covid-19 pandemic.

ABSTRACT:

Introduction

Covid-19 confers substantial risk for the >400,000 patients who receive methadone for the treatment of opioid use disorder (OUD) and methods for safely dispensing large quantities of methadone to patients are lacking.

Methods

This study evaluated the MedMinder "Jon", an electronic and cellular-enabled pillbox that provides real-time monitoring to remotely manage take-home doses of methadone using a 12-week, within-subject, Phase II (NCT03254043) trial. We transitioned all participants from liquid to tablet methadone one week prior to randomization. Participants completed both treatment-as-usual and electronic pillbox conditions before choosing a condition in a final "choice phase". We assessed feasibility, satisfaction, and safety outcomes during the exit interview.

Results

Overall, we randomized 25 participants, 24 (96.0%) completed >1 study session, and 21 (84.0%) completed the exit interview. We dispensed 167.92 g (1,974 doses) of methadone. Participants would use the pillbox again (86.3%) and recommend it to others (95.4%). Overall, 52.4% selected the pillbox in the choice condition and those who did not cited issues related to study requirements. Less than 1% of pillbox alerts were for medication being consumed outside the dosing window and we observed no evidence of actual or attempted methadone diversion.

Discussion

We were able to adequately manage patients who would not otherwise qualify for large quantities of take-home methadone when we dispensed methadone tablets via a secure pillbox. The integration of a commercially available pillbox into routine clinic operations increases opportunity for dispensing medication. Our data support remote monitoring of methadone take-home doses and may inform clinic practices related to Covid-19.

SUBMITTER: Dunn KE

PROVIDER: S-EPMC7834258 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Technology-assisted methadone take-home dosing for dispensing methadone to persons with opioid use disorder during the Covid-19 pandemic.

Dunn Kelly E KE Brooner Robert K RK Stoller Kenneth B KB

Journal of substance abuse treatment 20201124

<h4>Introduction</h4>Covid-19 confers substantial risk for the >400,000 patients who receive methadone for the treatment of opioid use disorder (OUD) and methods for safely dispensing large quantities of methadone to patients are lacking.<h4>Methods</h4>This study evaluated the MedMinder "Jon", an electronic and cellular-enabled pillbox that provides real-time monitoring to remotely manage take-home doses of methadone using a 12-week, within-subject, Phase II (NCT03254043) trial. We transitioned ...[more]

PMID: 33357606

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Project description:ImportanceDuring the COVID-19 pandemic, modified guidance for opioid agonist therapy (OAT) allowed prescribers to increase the number of take-home doses to promote treatment retention. Whether this was associated with an increased risk of overdose is unclear.ObjectiveTo evaluate whether increased take-home doses of OAT early in the COVID-19 pandemic was associated with treatment retention and opioid-related harm.Design, setting, and participantsA retrospective propensity-weighted cohort study of 21 297 people actively receiving OAT on March 21, 2020, in Ontario, Canada. Changes in OAT take-home dose frequency were assessed between March 22, 2020, and April 21, 2020, and individuals were observed for up to 180 days to assess outcomes (last date of follow-up, October 18, 2020).ExposuresExposure was defined as extended take-home doses in the first month of the pandemic within each of 4 cohorts based on OAT type and baseline take-home dose frequency (daily dispensed methadone, 5-6 take-home doses of methadone, daily dispensed buprenorphine/naloxone, and 5-6 take-home doses of buprenorphine/naloxone).Main outcomes and measuresPrimary outcomes were opioid overdose, interruption in OAT, and OAT discontinuation.ResultsAmong 16 862 methadone and 4435 buprenorphine/naloxone recipients, the median age ranged between 38 and 42 years, and 29.1% to 38.2% were women. Among individuals receiving daily dispensed methadone (n = 5852), initiation of take-home doses was significantly associated with lower risks of opioid overdose (6.9% vs 9.5%/person-year; weighted hazard ratio [HR], 0.73 [95% CI, 0.56-0.96]), treatment discontinuation (51.0% vs 63.6%/person-year; weighted HR, 0.80 [95% CI, 0.72-0.90]), and treatment interruption (19.0% vs 23.9%/person-year; weighted HR, 0.80 [95% CI, 0.67-0.95]) compared with no change in take-home doses. Among individuals receiving daily dispensed buprenorphine/naloxone (n = 662), there was no significant difference in any outcomes between exposure groups. Among individuals receiving weekly dispensed OAT (n = 11 010 for methadone; n = 3773 for buprenorphine/naloxone), extended take-home methadone doses were significantly associated with lower risks of OAT discontinuation (14.1% vs 19.6%/person-year; weighted HR, 0.72 [95% CI, 0.62-0.84]) and interruption in therapy (5.1% vs 7.4%/person-year; weighted HR, 0.69 [95% CI, 0.53-0.90]), and extended take-home doses of buprenorphine/naloxone were significantly associated with lower risk of interruption in therapy (9.5% vs 12.9%/person-year; weighted HR, 0.74 [95% CI, 0.56-0.99]) compared with no change in take-home doses. Other primary outcomes were not significantly different between groups.Conclusions and relevanceIn Ontario, Canada, during the COVID-19 pandemic, dispensing of increased take-home doses of opioid agonist therapy was significantly associated with lower rates of treatment interruption and discontinuation among some subsets of patients receiving opioid agonist therapy, and there were no statistically significant increases in opioid-related overdoses over 6 months of follow-up. These findings may be susceptible to residual confounding and should be interpreted cautiously.

Project description:IntroductionWe conducted a qualitative study to explore the impact of the COVID-19 pandemic on experiences with addiction treatment and harm reduction services.MethodsThe study recruited participants from Boston, Massachusetts, aged 18-65 who had a history of opioid use disorder and overdose, from a parent study (REpeated dose Behavioral intervention to reduce Opioid Overdose, REBOOT) to participate between August and October 2020. In-depth individual interviews explored the impact of the COVID-19 pandemic on addiction service experiences. We conducted a grounded content analysis that examined codes related to addiction service access and engagement during the pandemic to compare and categorize participants according to their experiences.ResultsThe study enrolled twenty participants. The mean age was 42 years; most identified as white (n = 16); ten participants identified as men, nine as cis-gender women, and one as a trans-gender woman. Participants described their experiences with COVID-19-driven changes to addiction care (methadone take homes, televisits for either buprenorphine or behavioral health services, and syringe service outreach) access and engagement as: 1) liberating (n = 7), 2) destabilizing (n = 8), or 3) unjust (n = 5). Participants in the liberating group found adaptations allowed for increased flexibility, freedom, and safety from COVID-19. This group was mostly housed and had strong social supports that facilitated participation in adapted treatment programs. COVID-19-related changes to addiction treatment disrupted routine and community supports among those in the destabilizing group. Participants in the unjust group felt that adaptations exacerbated inequities as a lack of housing and other social supports prohibited them from benefiting from the relaxed restrictions to methadone or buprenorphine. This group was mostly unhoused and found that adaptations did not adequately mitigate other inequities worsened by public health mandates for unhoused people who use drugs.ConclusionRelaxed restrictions on medications for opioid use disorder created opportunities for improved patient-centered care. Concrete measures that address service barriers, such as phone or transportation access, may have reduced destabilizing and unjust experiences reported by our participants. However, addiction care inequities will persist if drivers of marginalization, specifically a lack of housing, remain unaddressed.

Project description:BackgroundIn the United States, methadone for opioid use disorder (OUD) is highly regulated. Federal agencies announced guidelines in March 2020 allowing for relaxation of take-home methadone dispensing at opioid treatment programs (OTPs) to improve treatment access and reduce COVID-19 transmission risk during the public health emergency. We explored patient perspectives at three OTPs serving rural communities on how take-home policy changes were received and implemented and how these changes impacted their addiction treatment and recovery.MethodsWe completed semi-structured individual qualitative interviews in 2 phases: (1) August-October 2020 and (2) November 2020-January 2021 (total n = 46), anticipating possible policy changes as the pandemic progressed. We interviewed patients with OUD enrolled at 3 rural OTPs in Oregon. Participants received varying take-home methadone allowances following the COVID-19-related policy changes. All interviews were conducted via phone, audio-recorded, and transcribed. We conducted a thematic analysis, iteratively coding transcripts, and deductively and inductively generating codes.ResultsThe 46 participants included 50% women and 89% had Medicaid insurance. Three main themes emerged in the analysis, with no differences between study phases: (1) Adapting to changing OTP policies throughout the pandemic; (2) Recognizing the benefits, and occasional struggles, with increased take-home methadone dosing; and (3) Continuing policies and procedures post-pandemic. Participants described fears and anxieties around ongoing methadone access and safety concerns prior to OTP policy changes, but quickly adapted as protocols soon seemed "natural." The majority of participants acknowledged significant benefits to increased take-homes independent of reducing COVID-19 infection risk including feeling "more like a normal person," improved recovery support, reduced time traveling, and having more time with family and for work. Looking to a post-pandemic future, participants thought some COVID-19-related safety protocols should continue that would reduce risk of other infections, make OTP settings less stressful, and result in more individualized care.ConclusionsAs the pandemic progressed, study participants adapted to rapidly changing OTP policies. Participants noted many unanticipated benefits to increased take-home methadone and other COVID-19 protocols including strengthened self-efficacy and recovery and reduced interpersonal conflict, with limited evidence of diversion. Patient perspectives should inform future policies to better address the ongoing overdose epidemic.

Project description:ImportanceIn March 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) permitted states to relax restrictions on take-home methadone doses for treatment-adherent patients to minimize COVID-19 exposures.ObjectiveTo assess whether the methadone take-home policy change was associated with drug overdose deaths among different racial, ethnic, and sex groups.Design, setting, and participantsInterrupted time series analysis from January 1, 2018, to June 30, 2022. Data analysis was conducted from February 18, 2023, to February 28, 2023. In this population-based cohort study of drug overdose mortality including 14 529 methadone-involved deaths, monthly counts of methadone-involved drug overdose deaths were obtained for 6 demographic groups: Hispanic men and women, non-Hispanic Black men and women, and non-Hispanic White men and women.ExposureOn March 16, 2020, in response to the first wave of the COVID-19 pandemic, SAMHSA issued an exemption to the states that permitted up to 28 days of take-home methadone for stable patients and 14 days for less stable patients.Main outcome measuresMonthly methadone-involved overdose deaths.ResultsFrom January 1, 2018, to June 30, 2022 (54 months), there were 14 529 methadone-involved deaths in the United States; 14 112 (97.1%) occurred in the study's 6 demographic groups (Black men, 1234; Black women, 754; Hispanic men, 1061; Hispanic women, 520; White men, 5991; and White women, 4552). Among Black men, there was a decrease in monthly methadone deaths associated with the March 2020 policy change (change of slope from the preintervention period, -0.55 [95% CI, -0.95 to -0.15]). Hispanic men also experienced a decrease in monthly methadone deaths associated with the policy change (-0.42 [95% CI, -0.68 to -0.17]). Among Black women, Hispanic women, White men, and White women, the policy change was not associated with a change in monthly methadone deaths (Black women, -0.27 [95% CI, -1.13 to 0.59]; Hispanic women, 0.29 [95% CI, -0.46 to 1.04]; White men, -0.08 [95% CI, -1.05 to 0.88]; and White women, -0.43 [95% CI, -1.26 to 0.40]).Conclusions and relevanceIn this interrupted time series study of monthly methadone-involved overdose deaths, the take-home policy may have helped reduce deaths for Black and Hispanic men but had no association with deaths of Black or Hispanic women or White men or women.

Project description:Importance:The US opioid crisis was deemed a public health emergency in 2017. More than 130 individuals in the US die daily as a result of unintentional opioid overdose deaths. Objective:To measure use of take-home naloxone for overdose reversals performed by study participants with opioid use disorder receiving treatment at an opioid treatment program. Design, Setting, and Participants:In a year-long cohort study, between April 4, 2016, and May 16, 2017, 395 study participants enrolled at the University of New Mexico Addiction and Substance Abuse Opioid Treatment Program, an outpatient clinic treating substance use disorders. Inclusion criteria included all patients enrolled at University of New Mexico Addiction and Substance Abuse Opioid Treatment Program during the study enrollment period; positive history of opioid use disorder treated with methadone, buprenorphine, or naltrexone; and age 18 years or older. Exclusion criteria included allergy to naloxone and age younger than 18 years. The study closed 1 year after enrollment, on May 17, 2018. Data analysis was performed from May 2018 to July 2019. Exposure:Two doses of take-home naloxone combined with opioid overdose education were provided to study participants. Main Outcomes and Measures:The primary outcome was to measure the association of take-home naloxone with overdose reversals performed by patients with opioid use disorder enrolled in an opioid treatment program. Results:We enrolled 395 study participants (270 female [68.4%]; mean [SD] age, 35.4 [12.6] years; 260 [65.8%] with Hispanic white race/ethnicity) in the 1-year prospective trial. Sixty-eight female participants (25.2% of all female participants) were pregnant at the time of enrollment. Seventy-three of the 395 study participants (18.0%) performed 114 overdose reversals in the community. All community reversals were heroin related. Most study participants (86.8%) stated that the person on whom they performed an overdose reversal was a friend, relative, acquaintance, or significant other. In the year before enrollment, only 18 study participants (4.5%) had been prescribed naloxone. Conclusions and Relevance:Take-home naloxone as part of overdose education and naloxone distribution provided to patients in an opioid treatment program may be associated with a strategic targeted harm reduction response for reversing opioid overdose-related deaths. Policy makers may consider regulations to mandate overdose education and naloxone distribution in opioid treatment programs.

Project description:BackgroundHistorical restrictions on take-home medications for opioid use disorder have generated considerable debate. The COVID-19 pandemic shifted the perceived risks and benefits of daily clinic attendance and led to widespread policy reform, creating an unprecedented opportunity to explore the impact of more flexible prescribing. We conducted a qualitative systematic review to synthesize the evidence on providers' experiences with relaxing restrictions on take-home doses of medications prescribed for opioid use disorder during the COVID-19 pandemic.MethodsThe protocol for this systematic review was registered in PROSPERO (CRD42022360589; https://www.crd.york.ac.uk/prospero/). From Sept.-Nov. 2022, we searched Medline, Embase, CINAHL, PsycInfo, Web of Science, the Cochrane Register of Controlled Trials, and the grey literature from 2020 onward. Studies were eligible for inclusion if they used qualitative methods to investigate providers' experiences with relaxed restrictions on take-home medications for opioid use disorder during the COVID-19 pandemic. We appraised study quality using the CASP qualitative checklist and used thematic synthesis and GRADE-CERQual to synthesize the results.ResultsWe retrieved 13 articles representing 11 studies. Six were conducted in the United States and most focused on changes to methadone treatment. Providers' experiences with increased flexibilities around take-homes were broadly positive, despite widespread initial concern over client safety and the potential for medication misuse. For a small number of providers, concerns about diversion were a specific manifestation of more general unease with loss of control over clients and the treatment process. Most providers appreciated increased flexibilities and described them as enabling more individualized, person-centered care.ConclusionOur findings support the continuation of flexibilities around take-homes and demonstrate that regulations and policies that reduce flexibility around take-homes conflict with person-centered approaches to care. Stronger guidance and support from professional regulatory agencies may help increase uptake of flexibilities around take-homes.

Dataset Information

Technology-assisted methadone take-home dosing for dispensing methadone to persons with opioid use disorder during the Covid-19 pandemic.

Introduction

Methods

Results

Discussion

Publications

Technology-assisted methadone take-home dosing for dispensing methadone to persons with opioid use disorder during the Covid-19 pandemic.

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