Take-home Doses Research Articles

Clients’ experiences on North America’s first take-home injectable opioid agonist treatment (iOAT) program: a qualitative study

BackgroundTo support public health measures during the COVID-19 pandemic, oral opioid agonist treatment (OAT) take-home doses were expanded in Western countries with positive results. Injectable OAT (iOAT) take-home doses were previously not an eligible option, and were made available for the first time in several sites to align with public health measures. Building upon these temporary risk-mitigating guidelines, a clinic in Vancouver, BC continued to offer two of a possible three daily doses of take-home injectable medications to eligible clients. The present study explores the processes through which take-home iOAT doses impacted clients’ quality of life and continuity of care in real-life settings.MethodsThree rounds of semi-structured qualitative interviews were conducted over a period of seventeen months beginning in July 2021 with eleven participants receiving iOAT take-home doses at a community clinic in Vancouver, British Columbia. Interviews followed a topic guide that evolved iteratively in response to emerging lines of inquiry. Interviews were recorded, transcribed, and then coded using NVivo 1.6 using an interpretive description approach.ResultsParticipants reported that take-home doses granted them the freedom away from the clinic to have daily routines, form plans, and enjoy unstructured time. Participants appreciated the greater privacy, accessibility, and ability to engage in paid work. Furthermore, participants enjoyed greater autonomy to manage their medication and level of engagement with the clinic. These factors contributed to greater quality of life and continuity of care. Participants shared that their dose was too essential to divert and that they felt safe transporting and administering their medication off-site. In the future, all participants would like more accessible treatment such as access longer take-home prescriptions (e.g., one week), the ability to pick-up at different and convenient locations (e.g., community pharmacies), and a medication delivery service.ConclusionsReducing the number of daily onsite injections from two or three to only one revealed the diversity of rich and nuanced needs that added flexibility and accessibility in iOAT can meet. Actions such as licencing diverse opioid medications/formulations, medication pick-up at community pharmacies, and a community of practice that supports clinical decisions are necessary to increase take-home iOAT accessibility.

APA’s Government, Policy, and Advocacy Update (April 2023)

Back to table of contents Previous article Next article Government & LegalFull AccessAPA’s Government, Policy, and Advocacy Update (April 2023)Search for more papers by this authorPublished Online:23 Mar 2023https://doi.org/10.1176/appi.pn.2023.04.4.16APA Expresses Support for SAMHSA Expanding Access To Outpatient Treatment ProgramsThe Substance Abuse and Mental Health Services Administration (SAMHSA) has proposed a rule to make permanent some regulatory flexibilities for opioid treatment programs to provide patients with extended take-home doses of methadone. APA provided comments on the rule, supporting several of its provisions while also offering recommendations.“Methadone is a particularly effective form of MOUD [medications for opioid use disorder],” APA’s letter stated. “Unfortunately, the regulations governing methadone access have created significant barriers to care for many of those who need and want treatment.” The flexibilities for prescribing methadone that SAMHSA has allowed during the COVID-19 public health emergency “served as a starting point for reimagining methadone access in this time of vital need,” the letter continued.Specifically, APA expressed support for SAMHSA’s efforts to change regulatory language to reduce stigma toward people who use drugs or have an opioid use disorder (OUD); SAMHSA’s collaboration with the Drug Enforcement Administration to facilitate mobile medication units and increase methadone treatment for underserved populations; and SAMHSA’s proposal to eliminate the requirement that patients must have a one-year history of OUD to qualify for methadone treatment.Further, APA questioned some provisions, including limiting methadone treatment to people with moderate to severe OUD and excluding those with mild OUD. In the letter, APA also suggested that SAMHSA provide guidance on methods to ensure quality counseling services through, or coordinated with, the opioid treatment program.APA’s Letter to SAMHSA in Response to SAMHSA’s Proposed Rule on Methadone Access APA, AMA Urge CMS to Finalize Prior Authorization ReformsIn a letter to Chiquita Brooks-LaSure, M.P.P., the administrator of the Centers for Medicare and Medicaid Services (CMS), the AMA, APA, and nearly 120 organizations representing physicians across the country expressed their strong support for proposed rules that would reform the prior authorization process for Medicare Advantage plans and Medicare Part D.In particular, the organizations expressed support for provisions that improve the coverage criteria for medical necessity determinations and protect access to care. Other provisions that the organizations support would protect patients from care interruptions, treatment delays, and unanticipated medical costs.“Recent [AMA] survey data show that 93 percent of physicians report care delays or disruptions associated with [prior authorization],” the letter stated. “AMA data also show that 34 percent of physicians report that [prior authorization] has led to a serious adverse event (e.g., hospitalization, permanent impairment, or even death) for a patient in their care. … Moreover, the Office of Inspector General 2022 report found that 13 percent of [prior authorization] requests denied by Medicare Advantage plans met Medicare coverage rules.”APA, AMA’s Letter to CMS on Prior Authorization APA Responds to CMS’s Request for Information on Essential Health BenefitsCMS recently released a request for information on essential health benefits (EHB) established under the Affordable Care Act. In its response, APA highlighted barriers that patients face to accessing mental and substance use disorder (SUD) services, the importance of telehealth in improving access to these EHB services, and the potential for the Collaborative Care Model to address gaps in coverage.APA noted administrative barriers such as prior authorization, workforce issues, and lack of parity. “Patients often experience a delay in accessing care due to the persistent shortage of psychiatrists and coverage across the country,” APA’s letter, addressed to Brooks-LaSure, stated. “As demand for their services increase, psychiatrists continue to meet capacity limitations.”Further, APA signed a coalition letter urging CMS to consider children’s needs when addressing EHBs. The letter emphasized that children require services and care specifically suited to their unique developmental needs.“Amid the children’s mental health emergency, there is a strong need to reduce the current gaps in coverage related to pediatric mental health services,” the coalition’s letter stated. “EHB requirements can play an important role in addressing these coverage gaps by incorporating coverage of pediatric mental health services in the ‘pediatric services’ category.” ■APA’s Letter on Mental Health and SUD EHBsThe Coalition’s Letter on EHBs for Children ISSUES NewArchived

“Sign Me Up”: a qualitative study of video observed therapy (VOT) for patients receiving expedited methadone take-homes during the COVID-19 pandemic

BackgroundFederal and state regulations require frequent direct observation of methadone ingestion at an Opioid Treatment Program (OTP)—a requirement that creates barriers to patient access. Video observed therapy (VOT) may help to address public health and safety concerns of providing take-home medications while simultaneously reducing barriers to treatment access and long-term retention. Evaluating user experiences with VOT is important for understanding the acceptability of this strategy.MethodsWe conducted a qualitative evaluation of a clinical pilot program of VOT via smartphone that was rapidly implemented between April and August 2020 during the COVID-19 pandemic within three opioid treatment programs. In the program, selected patients submitted video recordings of themselves ingesting methadone take-home doses, which were asynchronously reviewed by their counselor. We recruited participating patients and counselors for semi-structured, individual interviews to explore their VOT experiences after program completion. Interviews were audio recorded and transcribed. Transcripts were analyzed using thematic analysis to identify key factors influencing acceptability and the effect of VOT on the treatment experience.ResultsWe interviewed 12 of the 60 patients who participated in the clinical pilot and 3 of the 5 counselors. Overall, patients were enthusiastic about VOT, noting multiple benefits over traditional treatment experiences, including avoiding frequent travel to the clinic. Some noted how this allowed them to better meet recovery goals by avoiding a potentially triggering environment. Most appreciated having increased time to devote to other life priorities, including maintaining consistent employment. Participants described how VOT increased their autonomy, allowed them to keep treatment private, and normalized treatment to align with other medications that do not require in-person dosing. Participants did not describe major usability issues or privacy concerns with submitting videos. Some participants reported feeling disconnected from counselors while others felt more connected. Counselors felt some discomfort in their new role confirming medication ingestion but saw VOT as a useful tool for select patients.ConclusionsVOT may be an acceptable tool to achieve equipoise between lowering barriers to treatment with methadone and protecting the health and safety of patients and their communities.

Patient experiences of methadone treatment changes during the first wave of COVID-19: a national community-driven survey

BackgroundDuring COVID-19, the Substance Abuse and Mental Health Services Administration (SAMHSA) allowed Methadone Maintenance Treatment (MMT) programs to relax in-person MMT requirements to reduce COVID-19 exposure. This study examines patient-reported changes to in-person methadone clinic attendance requirements during COVID-19.MethodsFrom June 7, 2020, to July 15, 2020, a convenience sample of methadone patients (N = 392) were recruited in collaboration with National Survivors Union (NSU) in 43 states and Washington D.C. through social media (Facebook, Reddit, Twitter, and Web site pop-ups). The community-driven research (CDR) online survey collected information on how patient take-home methadone dosing and in-person drug testing, counseling, and clinic visit frequency changed prior to COVID-19 (before March 2020) to during COVID-19 (June and July 2020).ResultsDuring the study time period, the percentage of respondents receiving at least 14 days of take-home doses increased from 22 to 53%, while the percentage receiving one or no take-home doses decreased from 22.4% before COVID-19 to 10.2% during COVID-19. In-person counseling attendance decreased from 82.9% to 19.4%. While only 3.3% of respondents accessed counseling through telehealth before COVID-19, this percentage increased to 61.7% during COVID-19. Many respondents (41.3%) reported visiting their clinics in person once a week or more during COVID-19.ConclusionsDuring the first wave of COVID-19, methadone patients report decreased in-person clinic attendance and increased take-home doses and use of telehealth for counseling services. However, respondents reported considerable variations, and many were still required to make frequent in-person clinic visits, which put patients at risk of COVID-19 exposure. Relaxations of MMT in-person requirements during COVID-19 should be consistently implemented and made permanent, and patient experiences of these changes should be explored further.

Access to tablet injectable opioid agonist therapy in rural and smaller urban settings in British Columbia, Canada: a qualitative study

BackgroundRural and smaller urban settings in Canada are disproportionately impacted by the overdose crisis, highlighting the need for novel public health interventions within these jurisdictions. Tablet injectable opioid agonist therapy (TiOAT) programs have been implemented in select rural communities as a means to address drug-related harms. However, little is known about the accessibility of these novel programs. Therefore, we conducted this study to understand the rural context and factors that affected access of TiOAT programs.MethodsBetween October 2021 to April 2022, individual qualitative semi-structured interviews were conducted with 32 individuals enrolled in a TiOAT program at participating rural and smaller urban sites in British Columbia, Canada. Interview transcripts were coded using NVivo 12 and data were analyzed thematically.ResultsTiOAT access varied considerably. TiOAT delivery in rural settings is complicated due to geographic challenges. Participants who were homeless and staying at a nearby shelter or those in centrally-located supportive housing had minimal issues compared to those living in more affordable housing on the outskirts of town with limited transportation options. Dispensing policies that required daily-witnessed ingestion multiple times daily were challenging for most. Only one site provided evening take-home doses whereas participants at the other site could only resort to the illicit opioid supply to address withdrawal outside of program hours. Participants described the clinics as providing a positive and familial social environment compared to experiences of stigma elsewhere. Medication interruptions did occur when participants were in hospital and custodial settings, leading to withdrawal, program discontinuation, and overdose risk.ConclusionsThis study highlights the beneficial ways in which health services tailored for people who use drugs can create a stigma-free environment with an emphasis on social bonds. Other factors such as transportation access, dispensing policies, and access in rural hospitals and custodial settings produced unique challenges for rural people who use drugs. Public health authorities in rural and smaller settings should consider these factors when designing, implementing, and scaling up future substance use services, including TiOAT programs.

Commentary on Nikoo et al.: Challenges in protocol development to optimize outcomes of opium tincture maintenance treatment.

Commentary on Nikoo et al.: Challenges in protocol development to optimize outcomes of opium tincture maintenance treatment.

The development and validation of the pandemic medication-assisted treatment questionnaire for the assessment of pandemic crises impact on medication management and administration for patients with opioid use disorders.

Pandemic and the globally applied restriction measures mainly affect vulnerable population groups, such as patients with opioid use disorders. Towards inhibiting SARS-Cov-2 spread, the medication-assisted treatment (MAT) programs follow strategies targeting the reduction of in-person psychosocial interventions and an increase of take-home doses. However, there is no available instrument to examine the impact of such modifications on diverse health aspects of patients under MAT. The aim of this study was to develop and validate the PANdemic Medication-Assisted Treatment Questionnaire (PANMAT/Q) to address the pandemic effect on the management and administration of MAT. In total, 463 patients under ΜΑΤ participated. Our findings indicate that PANMAT/Q has been successfully validated exerting reliability and validity. It can be completed within approximately 5 min, and its implementation in research settings is advocated. PANMAT/Q could serve as a useful tool to identify the needs of patients under MAT being at high risk of relapse and overdose.

Simple, Rapid Spectrophotometric Assay of Dispensed Methadone for Diversion Control.

Treatment of opioid use disorder with methadone is highly effective. Methadone is dispensed from opioid treatment programs under regulated circumstances. However, diversion of take-home doses can occur and is difficult to detect. We wanted to test the application of a handheld ultraviolet light absorption spectrometer to detect the concentration of methadone in take-home bottles that were suspected of being altered by the patient. Standardized dilutions of methadone hydrochloride oral concentrate were used to calibrate absorption wavelengths and then compared to take homes from suspected and unsuspected bottles to see if measured concentrations differed from expected doses. Ten standardized "control" doses were analyzed to determine 99% confidence intervals. These were compared to 104 samples "not-of-concern" obtained randomly over a 10-month period. An additional 103 methadone bottles of concern from 27 patients showed 15 bottles with <25 % and 8 with <75 % of expected concentrations. A handheld, low-cost ultraviolet light spectrometer detected altered take-home doses of methadone. This assay presents a simple and effective method for methadone clinics to perform inhouse analysis on "call back" methadone doses. It allows individual clinics to define diversion rates of their patient body, while allowing state and federal agencies to better understand how much prescribed methadone is diverted for illicit uses.

Nothing really changed: Arizona patient experience of methadone and buprenorphine access during COVID.

ObjectiveTo understand patient experience of federal regulatory changes governing methadone and buprenorphine (MOUD) access in Arizona during the COVID-19 pandemic.MethodsThis community-based participatory and action research study involved one-hour, audio-recorded field interviews conducted with 131 people who used methadone and/or buprenorphine to address opioid use disorder at some point during COVID (January 1, 2020- March 31, 2021) in Arizona. Transcribed data were analyzed using a priori codes focused on federally recommended flexibilities governing MOUD access. Data were quantitated to investigate associations with COVID risk and services access.ResultsTelehealth was reported by 71.0% of participants, but the majority were required to come to the clinic to attend video appointments with an offsite provider. Risk for severe COVID outcomes was reported by 40.5% of the sample. Thirty-eight percent of the sample and 39.7% of methadone patients were required to be at the clinic daily to get medication and 47.6% were at high risk for COVID severe outcomes. About half (54.2%) of methadone patients indicated that some form of multi-day take home dosing was offered at their clinic, and 45.8% were offered an extra day or two of multi-day doses; but no participants received the federally allowed 14- or 28-day methadone take-home doses for unstable and stable patients respectively. All participants expressed that daily clinic visits interrupted their work and home lives and desired more take-home dosing and home delivery options.ConclusionsMOUD patients in Arizona were not offered many of the federally allowed flexibilities for access that were designed to reduce their need to be at the clinic. To understand the impact of these recommended treatment changes in Arizona, and other states where they were not well implemented, federal and state regulators must mandate these changes and support MOUD providers to implement them.

Acceptability, feasibility, and outcomes of a clinical pilot program for video observation of methadone take-home dosing during the COVID-19 pandemic

BackgroundMethadone is one of the most utilized treatments for opioid use disorder. However, requirements for observing methadone dosing can impose barriers to patients and increase risk for respiratory illness transmission (e.g., COVID-19). Video observation of methadone dosing at home could allow opioid treatment programs (OTPs) to offer more take-home doses while ensuring patient safety through remote observation of ingestion. MethodsBetween April and August 2020, a clinical pilot program of video observation of methadone take-home dosing via smartphone was conducted within a multisite OTP agency. Participating patients completed a COVID-19 symptom screener and submitted video recordings of themselves ingesting all methadone take-home doses. Patients who followed these procedures for a two-week trial period could continue participating in the full pilot program and potentially receive more take-home doses. This retrospective observational study characterizes patient engagement and compares clinical outcomes with matched controls. ResultsOf 44 patients who initiated the two-week trial, 33 (75 %) were successful and continued participating in the full pilot program. Twenty full pilot participants (61 %) received increased take-home doses. Full pilot participants had more days with observed dosing over a 60-day period than matched controls (mean = 53.2 vs. 16.6 days, respectively). Clinical outcomes were similar between pilot participants and matched controls. ConclusionsVideo observation of methadone take-home dosing implemented during the COVID-19 pandemic was feasible. This model has the potential to enhance safety by increasing rates of observed methadone dosing and reducing infection risks and barriers associated with relying solely on face-to-face observation of methadone dosing.

Effectiveness of a digital medication event reminder and monitor device for patients with tuberculosis (SELFTB): a multicenter randomized controlled trial

BackgroundTuberculosis remains the leading cause of death from a single infectious disease worldwide. Trials evaluating digital adherence technologies for tuberculosis in low- and middle-income countries are urgently needed. We aimed to assess whether a digital medication event reminder and monitor (MERM) device-observed self-administered therapy improves adherence and treatment outcomes in patients with tuberculosis compared with the standard in-person directly observed therapy (DOT).MethodsWe did a two-arm, attention-controlled, effectiveness-implementation type 2 hybrid, randomized controlled trial in ten healthcare facilities in Addis Ababa, Ethiopia. We included adults with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary tuberculosis who were eligible to start anti-tuberculosis therapy. Participants were randomly assigned (1:1) to receive a 15-day tuberculosis medication supply in the evriMED500® MERM device to self-administer and return every 15 days (intervention arm) or visit the healthcare facilities each day to swallow their daily dose with DOT by healthcare providers (control arm). Both arms were followed throughout the standard two-month intensive treatment phase (2RHZE). For control participants, some provider-approved take-home doses might be allowed for extenuating circumstances in real-world practice. Data were collected on patient information (demographic, socioeconomic, behavioral, social, and clinical information), medication adherence measures (MERM vs. DOT records, IsoScreenTM urine colorimetric isoniazid test, and adherence self-report), and clinical measures (pre-post treatment sputum Xpert MTB/RIF assay or microscopy, and adverse treatment outcomes). The intention-to-treat (ITT) primary endpoints were (1) individual-level percentage adherence over the two-month intensive phase measured by adherence records compiled from MERM device vs. DOT records that also considered all take-home doses as having been ingested and (2) sputum smear conversion following the standard two-month intensive phase treatment. Secondary endpoints were (1) individual-level percentage adherence over the two-month intensive phase measured by adherence records compiled from the MERM device vs. DOT records that considered all take-home doses as not ingested, (2) negative IsoScreen urine isoniazid test, (3) adverse treatment outcome (having at least one of the three events: treatment not completed; death; or loss to follow-up), and (4) self-reported adherence. The MERM device has an electronic module and a medication container that records adherence, stores medication, emits audible and visual on-board alarms to remind patients to take their medications on time and refill, and enables providers to download the data and monitor adherence.ResultsParticipants were enrolled into the study between 02 June 2020 and 15 June 2021, with the last participant completing follow-up on 15 August 2021. A total of 337 patients were screened for eligibility, of whom 114 were randomly assigned and included in the final analysis [57 control and 57 intervention participants]. Participants were 64.9% male, 15% with HIV, 10.5% retreatment, and 5.3% homeless. Adherence to TB medication was comparable between the intervention arm [geometric mean percentage (GM%) 99.01%, geometric standard deviation (GSD) 1.02] and the control arm [GM% 98.97%, GSD 1.04] and was within the prespecified margin for non-inferiority [mean ratio (MR) 1.00 (95% CI 0.99–1.01); p = 0.954]. The intervention arm was significantly superior to the control arm in the secondary analysis that considered all take-home doses in the control were not ingested [control GM% 77.71 (GSD 1.57), MR 1.27 (95% CI 1.33–1.43)]. Urine isoniazid testing was done on 443 (97%) samples from 114 participants; 13 participants had at least one negative result; a negative test was significantly more common among the control group compared with the intervention group [11/57 (19.3%) vs 2/57 (3.5%); p = 0.008]. There was no significant difference between the control and intervention arms for smear conversion [55 (98.2%) vs 52 (100%); p>0.999], adverse treatment outcomes [0 vs 1 (1.9%); p = 0.48], and self-report non-adherence [5 (8.9%) vs 1 (1.9%); p = 0.21].ConclusionsIn this randomized trial of patients with drug-sensitive pulmonary tuberculosis, medication adherence among participants assigned to MERM-observed self-administered therapy was non-inferior and superior by some measures when compared with the standard in-person DOT. Further research is needed to understand whether adherence in the intervention is primarily driven by allowing self-administered therapy which reduced challenges of repeated clinic visits or by the adherence support provided by the MERM system. To avoid contributing to patient barriers with DOT, tuberculosis medical programs should consider alternatives such as medication event monitors.Trial registrationClinicalTrials.gov, NCT04216420.

Quality of Life among Methadone Maintenance Patients after the 4th Wave of COVID-19 in Ho Chi Minh City, Vietnam

INTRODUCTION: This study aimed to assess the quality of life (QOL) of methadone maintenance patients in Ho Chi Minh City after the most devastating wave of COVID-19 and to explore factors that influence their QOL. 
 
 METHODS: A cross-sectional study was conducted on 230 people who were in a methadone maintenance phase at the Tan Binh methadone treatment clinic using WHOQoL-BREF questionnaires. Ten in-depth interviews were carried out with patients and health staff, who were purposely selected. 
 
 RESULTS: The overall QOL score of study participants according to the 100-point WHOQoL-BREF scale was 64.6 ± 9.8, in which the highest average score was the physical health domain (68.3 ± 11.1 points) and the lowest was the social relationship domain (59.1 ± 13.5 points). MMT patients’ employment was found to be strongly affected by the COVID-19 epidemic, with higher unemployment or unstable jobs that negatively influence their QOL. In contrast, the take-home dose policy applied during lockdown was reported as a positive factor and well accepted. Family support and marriage also positively affected their QOL scores, whereas those with positive urine test results reported lower QOL scores. 
 
 CONCLUSION: Employment and social support for MMT patients has emerged, and further studies should be carried out to provide adequate evidence for methadone treatment improvement, including a multi-day take-home dose initiative.

Experience and insights from the emergency multiday take-home dose methadone dispensing in Ho Chi Minh City in context of COVID-19

Introduction: We aimed to assess the uptake of the pilot multiday take-home dose methadone program during COVID-19 by the patients and document the experience with this novel approach to Methadone Maintenance Treatment (MMT) in Vietnam through this operational research. Materials and methods: A total of 10 clinics were identified randomly using the PPS method. A total of 502 patients were selected from the clinics using a simple randomization technique. The information was collected from the administrative and treatment records and direct face-to-face interview with the patients. Results: None of the clinics reported an incidence of overdose. A large majority of the patients reported that take home methadone program as being convenient (79.6%) and agreed that they shall like to join the multiday take-home dose in future (98.7%). Conclusions: The findings of the current study suggested that the multiday take-home methadone program was feasible and well accepted by the patients in Ho Chi Minh City. It helped ensure continuity of care to patients on MMT during the COVID-19 pandemic.

Mixed-methods study to examine the response of opioid addiction treatment programmes to COVID-19: a study protocol

IntroductionThe COVID-19 pandemic is forcing changes to clinical practice within traditional addiction treatment programmes, including the increased use of telehealth, reduced restrictions on methadone administration (eg, increased availability of take-home...

Personalized Care in Opioid Use Disorder maintained on Buprenorphine

IntroductionEffectiveness of buprenorphine (BUP) is moderated by medication misuse diversion and non-adherence, and poor retention and high cost. Contingency Managment has added benefit to BUP with Take-home doses as the most preferred reward by Opioid Use Disorder patients.ObjectivesExamine the clinical effectiveness of a novel incentivised medication adherence and abstinence monitoring to enable contingent access to increasing BUP take-home doses.Explore associations with opioid use and retention. Contrast characteristics of polysubstance abusers (PSA) and response to BUP, with single opioid users.MethodsTwo-arm, pragmatic, 16-week outpatient RCT of BUP maintenance.Takehome doses were provided as stepped-approach upto 4-weeks contingent of abstinence (UDS) and adherence according to Therapeutic Drug Monitoring-TDM. Primary outcome and secondard outcomes were % negative UDS for opioids anx retention, respectively. -ResultsOpioid % negative UDS was 76.7% (SD 25.0%) in I-AAM versus 63.5% (SD 34.7%) in TAU (13.3%; 95% [CI] 3.2%–23.3%; Cohen’s d 0.44; 95% CI 0.10–0.87). In I-AAM, 40 participants (57.1%) were retained versus 33 (46.4%) in TAU [OR: 1.54; 95% CI 0.79–2.98). PSA (73.7%, n=104) and carisprodol use increases non-fatal overdose (OR) 3.83, 95% CI 1.25 to 11.71) and 5.31, 95% CI 1.92 to 14.65], respectively. Opioid and non-opioid UDS are positively associated. BUP elimination rate (BUP-EL.R) predicts 26.5% to 65% of negative opioid UDS [Beta - 89.95, 95% CIl -154.20 to -25.70, R2 0.22]. Family enagement increases retention by 3-fold.ConclusionsBUP + incentivised TDM for contingent access to increasing take-home doses increased abstinence. BUP-EL.R seems promising in BUP treatment precision and BUP is clinically valuable in polysubstance abusers.Engaging family enhances retention.DisclosureNo significant relationships.

Treatment retention, return to use, and recovery support following COVID-19 relaxation of methadone take-home dosing in two rural opioid treatment programs: A mixed methods analysis

ObjectivesIn March 2020, the Substance Abuse and Mental Health Services Administration permitted Opioid Treatment Programs (OTPs) to relax restrictions on take-home methadone and promoted telehealth to minimize potential exposures to COVID-19. We assessed the effects of COVID-19-related changes on take-home methadone dosing in two OTPs serving five rural Oregon counties. MethodsWe used a mixed-methods convergent design. The OTPs extracted urine drug test (UDT) results, take-home methadone regimens, and treatment retention from the electronic health record (EHR) for patients (n = 377). A mixed-effects negative binomial regression model assessed patient-level differences in take-home doses before and after the COVID-19 policy changes and the associations with treatment discontinuation, and UDT positivity. Semi-structured qualitative interviews (n = 32) explored patient reactions to increased take-home dosing and reduced clinic visits to provide context for quantitative findings. ResultsThe number of take-home doses increased in the post-COVID-19 period for patients engaged in treatment for more than 180 days (median: 8 vs 13 take-home doses per month, p = 0.011). Take-homes did not increase for patients with fewer days of treatment. Each percentage point increase in take-home dosing above what would be expected without COVID-19 policy changes was negatively associated with the percent of UDT positive for opioids (B = −0.12, CI [−0.21, −0.04], p = 0.005) and the probability of treatment discontinuation (aOR = 0.97, CI [0.95, 0.99], p = 0.003). Qualitative analysis revealed three themes explaining how increased take-home dosing supported recovery: 1) value of feeling trusted with increased responsibility; 2) reduced travel time permitted increased employment and recreation; and 3) reduced exposure to individuals less stable in recovery and potential triggers. ConclusionsTake-home methadone dose relaxations were associated with increased methadone take-home doses, improved retention, and decreased UDT opioid positive results among clinically stable patients. Qualitative findings suggest that fewer take-home restrictions are feasible and desirable and do not pose safety or public health harms.

Characterizing the Clinical use of a Novel Video-assisted Dosing Protocol With Secure Medication Dispensers to Reduce Barriers to Opioid Treatment.

Distance and travel costs to opioid treatment programs (OTPs), especially in rural communities, are barriers to treatment for opioid use disorder. Retention rates at 12 months in our OTP are 55% (range 53%-61%).We piloted a novel treatment platform utilizing a video directly observed therapy (VDOT) smartphone app and a secure medication dispenser to support adherence with take-home doses of methadone or buprenorphine while enabling patients to maintain prosocial activities, reduce time and cost of travel, and increase retention. Participants (n¼58) were adults in a Vermont OTP. Inclusion criteria included travel hardship, access to Wi-Fi or cellular network, and having an iPhone 4S or Android 4.0 or greater. Patients received a dispenser, VDOT app, clinic dispensed medication, counseling, and urine drug testing. Chart reviews assessed VDOT compliance, engagement in prosocial activities, travel costs and time savings, and treatment disposition/retention. Project-associated costs were examined. Of the 15,831 expected videos, 15,581 (98.4%) were received and only 10 (0.063%) showed signs of medication noncompliance with 1 (0.0064%) showing an overt attempt at diversion. About 93% of participants engaged in prosocial activities, travel time and costs were reduced 86%, median cost saved $72 weekly, median travel time saved 5.5 hours weekly and 98% of participants were in treatment 12 months later. VDOT participants using dispensers showed high levels of medication ingestion integrity, had favorable clinical stability, and lower travel time and costs. These findings suggest that using VDOT with dispensers may hold promise as an innovative platform for supporting medication adherence.

Evaluating interventions to facilitate opioid agonist treatment access among people who inject drugs in Toronto, Ontario during COVID-19 pandemic restrictions.

BackgroundIn March 2020, following a provincial COVID-19 emergency declaration, modifications to opioid agonist treatment (OAT) were introduced in Ontario, Canada to promote treatment access amid the pandemic and ongoing opioid overdose crisis. Modifications included federal exemptions to facilitate OAT prescription re-fills, extensions, and deliveries and interim treatment guidance emphasizing take-home (non-observed) doses and reduced urine drug screening for OAT patients.MethodsWe conducted an interrupted time series study using health administrative data from September 17th, 2019–September 21st, 2020, on 359 people who inject drugs with suspected opioid use disorder in Toronto, Ontario. We used segmented regression analyses to evaluate the joint effects of the provincial COVID-19 emergency declaration, federal OAT exemptions, and interim treatment guidance—all implemented between March 17th–23rd, 2020—on the weekly proportion of participants enrolled in OAT (i.e., ≥1 day(s) covered with methadone or buprenorphine/naloxone), with an opioid-related overdose (based on emergency department visits and hospitalizations), and who died (all-cause), and the weekly proportion of OAT-enrolled participants receiving take-home doses (i.e., ≥1 day(s) covered) and undergoing urine drug screening.ResultsPost-implementation, the interventions were associated with immediate absolute changes in OAT enrollment (+1.95%; 95% CI=0.04%–3.85%), receipt of take-home doses (+18.3%; 95% CI=13.2%–23.4%), and urine drug screening (-22.4%; 95% CI=[-26.9%]–[-17.9%]) and a gradual absolute increase of 0.56% in urine drug screening week-to-week (95% CI=0.27%–0.86%) beyond the pre-implementation trend. At 26 weeks post-implementation, OAT enrollment and urine drug screening approached pre-implementation levels whereas the increase in take-home doses was largely sustained (+15.0%; 95% CI=4.33%–25.6%). No post-implementation increases in opioid-related overdoses were observed. Death was not modelled (low event frequency).ConclusionChanges to OAT provision following provincial COVID-19 restrictions were associated with an immediate and sustained increase in take-home dose coverage among OAT-enrolled participants, without corresponding increases in opioid-related overdoses among all participants.

Lessons from the First Wave of COVID-19 for Improved Medications for Opioid Use Disorder (MOUD) Treatment: Benefits of Easier Access, Extended Take Homes, and New Delivery Modalities

Background Medications for Opioid Use Disorder (MOUD) are associated with important public health benefits. Program changes implemented in response to COVID-19 hold promise as ongoing strategies to improve MOUD treatment. Methods: MOUD patients on buprenorphine or methadone, providers, government regulators, and persons who use drugs not in MOUD were recruited in the Northeast region of the United States between June and October of 2020 via advertisements, fliers, and word of mouth. Semi-structured qualitative interviews were conducted. Interviews were professionally transcribed and thematically coded by two independent coders. Results: We conducted interviews with 13 people currently on buprenorphine, 11 currently on methadone, 3 previously on buprenorphine, 4 previously on methadone, and 6 who used drugs but had never been on MOUD. In addition, we interviewed MOUD providers, clinic staff, and government officials at agencies that regulate MOUD. Most participants found increased take-home doses, home medication delivery, and telehealth implemented during COVID-19 to be favorable, reporting that these program changes reduced travel time to clinics, facilitated retention in care, and reduced stigma associated with clinic attendance. However, some participants reported negative consequences of COVID-19, most notably, decreased access to basic resources, such as food, clothing, and harm reduction materials that had previously been distributed at some MOUD clinics. Conclusion: Access to and retention in MOUD can be lifesaving for persons using drugs. COVID-19-impelled program changes, including increased take-home doses, home medication delivery, and telehealth generally improved participants’ experiences with MOUD. Making these permanent could improve retention in care.

The epidemic within the pandemic: Behavioral health and substance use in the face of COVID-19

The epidemic within the pandemic: Behavioral health and substance use in the face of COVID-19