key: cord-0696444-2a0aqdop
authors: Hoffman, Kim A.; Foot, Canyon; Levander, Ximena A.; Cook, Ryan; Terashima, Javier Ponce; McIlveen, John W.; Korthuis, P. Todd; McCarty, Dennis
title: 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
date: 2022-05-08
journal: J Subst Abuse Treat
DOI: 10.1016/j.jsat.2022.108801
sha: 954db8502051097dadf9524f0b079b15b97de359
doc_id: 696444
cord_uid: 2a0aqdop

OBJECTIVES: In 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. METHODS: We 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. RESULTS: The 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. CONCLUSIONS: Take-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.

The Substance Abuse and Mental Health Services Administration (SAMHSA) released guidance (March 16, 2020) to State Opioid Treatment Authorities (SOTAs) that they could request blanket exceptions and permit opioid treatment programs (OTPs) to dispense additional take-home methadone to improve treatment access and reduce COVID-19 transmission risk during the COVID-19 public health emergency. Federal regulations limit access to take-home medication based on the number of days in care and eight criteria that must be met to obtain additional take-homes (see summary in Table 1 ) and require documentation of rationale for increases or decreases in take-home dosing regimens. Limited access to take-home methadone results in many patients attending clinic in-person five to six days per week and waiting in lines to receive their daily dose. Given concerns around congested settings at OTPs, SAMHSA relaxed limits on take-homes allowing -clinically stable patients‖ to receive up to 27 days and -less stable patients‖ to receive up to 13 days of take-homes (Substance Abuse and Mental Health Services Administration, 2020).

Reports from 20 OTPs in Oregon documented a 50% reduction in monthly clinic visits and a 100% increase in number of take-home doses dispensed monthly (pre-COVID, the modal number of take-homes per patient was one, post-COVID the distribution was bimodal with peaks at one and 27 take-homes per patient) . Early reports in rural communities raised concerns about the negative impacts of COVID-19 on mental health and substance use (Stack et al., 2021) . Travel time and distance from OTPs can be especially to the enhanced access to take-home methadone in two OTPs that served five Southern Oregon rural counties.

The two clinics followed SAMHSA guidelines and issued up to 27 days of take-home medications for -stable‖ clients despite time in treatment (i.e., negative UA for past 60 days, adherence to treatment plan for at least 60 days, no behavioral health difficulties, stable housing, no past diversion activity, safe medication storage). Working with the client and the client's counselor, they evaluated each patient's condition and issued up to 27 days of takehomes if deemed stable and the patient was comfortable with 27 take-homes (S. Denny, personal communication, March 7, 2022) . SAMHSA also allowed for up to 13 days of takehomes for clients considered less stable (adherence to treatment plan for at least 30 days, absence of diversion activity, at least 30 days of negative toxicology screens). The clinics made decisions on a case-by-case basis. The COVID-19 take-home exception was mainly used for patients who tested positive for COVID, met the -less stable‖ criteria, and needed to distance from the clinic (S. Denny, personal communication, March 7, 2022).

We used a mixed methods convergent design to abstract and analyze quantitative data from electronic health records and qualitative data from semi-structured interviews with patient participants (Creswell & Creswell, 2018) . A non-profit behavioral health and primary care center operated the two OTPs. The Oregon Health and Science University Institutional Review Board approved the study as a minimal risk intervention and permitted a verbal consent process for qualitative interviews.

data on monthly urine drug screens, admission date to the OTP, number of in-clinic and takehome doses per month and patient demographics (e.g., age, gender, race, ethnicity) and provided the study team with a deidentified dataset (please see consort diagram, Figure 1 ).

Journal Pre-proof 2.1.1 Urine drug tests. Consistent with federal guidelines, patients provided random monthly urine drug tests (UDTs); EHR data included the monthly number of UDTs administered and the percent positive for opioid use. The study categorized a patient as having discontinued treatment if their last recorded methadone dose occurred during the COVID-19 study period (April 2020 to September 2020). Covariates included age, gender, days in treatment as of September 2019 (the beginning of the study period) or when they entered care, and patient's cumulative proportion of opioid positive UDT during the pre-COVID period. The analysis compared opioid positive drug test percentages before (September 1, 2019, to February 28, 2020) and after (April 1, 2020 , to September 30, 2020 the SAMHSA policy relaxation. The study excluded March 2020 as the SAMHSA exception became effective mid-month. We restricted data to methadone patients (n = 377) who received methadone during the study period.

The study compared proportion of take-home doses, opioid positive drug tests, and retention rates between pre-and post-COVID periods, stratified by time in treatment (0 to 90 days, 91 to 180 days, 181 days or more). The analysis included all patients who received methadone during the study period (n = 377). Time in treatment was a time-varying variable-someone could have been in treatment for fewer than 90 days during the pre-COVID period, and more than 90 days following the policy change, and -contributed‖ to both exposure categories. Our primary analysis estimated the effect of SAMHSA's blanket exception on opioid drug screen positivity rates and treatment discontinuation. take-home proportion to vary for each patient and period. The model also included patientspecific random slopes for time in treatment, allowing the take-home dose trajectory to vary between patients according to the length of time they had been in treatment at the OTP prior to the study.

To assess the counterfactual scenario in which no guideline change occurred, the study limited a person-specific (random effects) model to patients with at least three months of pre-COVID data and one month of post-COVID data (n = 216); three months of pre-COVID data were required to estimate patient-specific treatment trends leading up to the guideline change, and one month of post-COVID data allowed inclusion of individuals who discontinued treatment during the post-COVID period. The model generated patient-specific estimates of the expected take-home dose proportion for each period. We contrasted these estimates to obtain a quantitative measure of take-home doses received above or below expected for each patient, representing the difference between the observed guideline change (the post-COVID period) and what would have been expected under no change (estimated during the pre-COVID period, accounting for pre-COVID UDT results, demographics, and treatment trajectory). Positive values indicated that patients received more take-homes than expected given no change in guidelines. Two regression models were fit comparing this quantity, the -take-homes above expected,‖ with the patient's rate of opioid positive UDT results in the post-COVID period (a linear regression model) and the likelihood of treatment discontinuation during the post-COVID period (a logistic regression model). These models adjusted for patient age, gender, clinic, time in treatment, and pre-COVID UDT positivity.

A case study approach using a constructivist paradigm provided the framework for the qualitative portion of the study. The study team developed research questions and an interview guide using an iterative group process to explore patient experiences and reactions to increased take-home dosing. Highly trained and experienced J o u r n a l P r e -p r o o f Journal Pre-proof qualitative researchers (KAH and XAL) conducted in-depth, semi-structured qualitative interviews with a convenience sample of 32 patient participants at the two OTPs. The interviewers did not have previous contact with the participants and built trust and rapport with participants during the informed consent process, ensuring that patients understood that their responses were confidential and would not impact their relationship with the OTP or their counselor. Interviews were conducted until data saturation was achieved. Participants received compensation of $40.00 following interview completion. Participants had varying take-home methadone allowances following the COVID-19 policy changes. The study completed the interviews in 2 waves: 1) August-September 2020 and 2) November-December 2020 (total n=32). We conducted all interviews via phone using best practices for virtual collection of qualitative data ; interviews were audio-recorded and professionally transcribed.

We conducted a thematic analysis following Braun and Clark's (2006) guidelines. Three researchers (KAH, XAL, and JPT) developed a list of preliminary codes after reading interview transcripts, with codes grouped into overarching themes. Data were iteratively analyzed at the semantic level using Atlas.ti (ATLAS.ti Scientific Software Development GmbH, 2020) for data management. Two coders performed the coding (KAH and XAL). Ten percent of the sample was double coded to check for inter-coder agreement. A third coder (JPT) adjudicated the double coded sample. The study achieved an inter-coder agreement rate of 85%.

3.1.1 Overall effects. The patients were primarily non-Hispanic White (93%) women (49%) and men (51%) with a mean age of 40 years (SD = 11) and a median care duration of 532 (IQR: 257, 851) days (from treatment entry to the end of the study period; see Table 2 ). J o u r n a l P r e -p r o o f Journal Pre-proof Two-thirds (65%) of patients were in the program at the beginning of the study period, and 47% of the initial cohort remained through the end of the study period.

Figure 2 displays trends in patient take-home dosing (median number and percentages), UDT opioid positivity by length of time in treatment, and treatment discontinuation; we summarize these results across the two periods in Table 3 (n = 377). Patients in care for more than 180 days had a significant increase in median per month take-home dosing (premedian= 8 take-homes; postmedian = 13 take-homes per month, p = 0.011). The proportion of positive UDT results or retention rate in treatment did not change. Patients in treatment fewer than 90 days did not have an increase in take-home doses and were more likely to discontinue treatment in the post-COVID period (13% discontinuation pre-COVID vs. 26% post, p = .047).

Patients in treatment for 90 to 180 days did not receive more take-homes following the takehome relaxation and their UDT opioid positivity rate increased post-COVID (19% to 33%, p = .041).

3.1.2 Take homes above expected analysis. The 216 patients included in the -takehomes above expected‖ analysis had more days in care than those in the overall patient population, with a median of 688 days in treatment (IQR: 482, 936). On average, these patients received 42% of their doses as take-homes pre-COVID. The take-home rate increased to 57% following the COVID-19 policy relaxation. In the mixed effects model estimating take-home doses above expected, take-home dosing increased an average of 15% (95% CI 0.11, 0.19; p < 0.001). A negative relationship existed between the increase in take-home dosing and post-COVID policy relaxation UDT opioid positivity (B = -0.12, 95% CI -0.21, -0.04; p = 0.005). The adjusted odds of treatment discontinuation declined 0.97 for every one-percentage point increase in take-home dosing above expected (aOR = 0.97, 95% CI 0.95, 0.99; p = 0.003).

The 32 interviewed participants were non-Hispanic White (81%), women (50%) with a mean age of 42.6 years. The qualitative interviews assessed the specific aspects of methadone J o u r n a l P r e -p r o o f Journal Pre-proof take-homes that participants found most helpful to contextualize the quantitative findings.

Overall, participants found increased take-home doses effective and acceptable without return to substance use. Three themes emerged: 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.

3.2.1 Theme 1: Value of feeling trusted with increased responsibility. Most participants given more take-home doses expressed appreciation for the opportunity and did not want to jeopardize their dosing schedule: "It's took me a long time to get to this point, so I'm not going to do anything to mess that up." [Case Wave 2_11]. Many expressed a sense of pride in being given the responsibility for their take-home doses, which instilled a feeling of trust and enhanced their recovery. One participant noted that the take-homes "helped her recovery," later on explaining, ...I feel that it's given me a sense of responsibility. I wasn't sure if I was ready to handle--but of course, I rose to the challenge. That makes me feel proud of myself. It really does. Having that responsibility and taking care of them on my own. [Case Wave 1_09] This sense of responsibility indicated to participants that they had grown in their recovery over time, and they felt affirmed they were on the right track:

Not to give myself a pat on the back but like compared to the beginning I must be doing well to get that many. It Due to the nature of the large catchment area of the clinic, many respondents reported traveling up to an hour or more from their homes to reach the clinic. Increased take-homes meant fewer trips to the clinic, which saved time and reduced stress:

Some participants who were not yet on 27-day take-home schedules aspired to become 

potential triggers. Another positive aspect of not having to commute into the town center where the clinics were located related to avoiding chance encounters with people who participants knew and possible triggers related to previous substance use:

It's a small town. You run into people that you used to use with or … you have known from before, so having the month's take-homes and only having to deal with that once a month is so much nicer than having to try to avoid those people on a daily basis. I really, really appreciate having the take-homes…most people already know from seeing you at the clinic that you don't want to talk to them or you don't want to have a part of that life so they kind of keep their distance like outside of here too. So that makes it nice for making that barrier. [Case Wave 1_13] This sentiment was echoed by another respondent:

'Cause when I would come here every day, I see people that I used with every day. And so when I am not seeing them every day I am getting a different type of habit. I am growing a different type of a habit outside of the clinic and so it's better for me that way I guess. I have changed people, places and things in my life so when I come here and I still see some of the same ol' people doing the same old things that kind of stuff bothers me now and so I like--so that's where I like being able to come just once a month. [Case Wave 2_15] Given that the clinic was limiting the number of individuals who could be in the waiting room, patients would often stand in a queue outside. When asked what aspects they enjoyed about having more take-homes, a participant explained: -You don't have to listen to the crap--outside

A working mother mentioned that it was difficult for her to get childcare early in the morning, and she preferred that her daughter not have contact with individuals they might encounter on their way to the clinic: 

The relaxation of take-home methadone restrictions was associated with increased distribution of take-home medication among established patients. Quantitative analyses suggested that increased take-homes did not increase, and potentially slightly decreased, use of illicit opioids and the likelihood of treatment discontinuation. We observed, however, that patients who had been in treatment for fewer than 90 days were more likely to discontinue treatment in the post-COVID period. Because this group saw no change in take-out dosing, this finding may be due to COVID-19 disruptions and stressors. Also of note, one OTP's patients had more days in treatment prior to the policy change, an important difference given that the literature shows better outcomes for people retained in care for longer periods (Chan et al., 2020; Sordo et al., 2017) . The OTP had been established two years prior to the other site.

These findings provide additional data on how patients adapted to COVID-19-related policy changes, the benefits and challenges with increased take-home doses, and possibilities for future directions of OTP-related regulations (Harris et al., 2021; Levander, Hoffman, et al., 2021) . Qualitative reports of continued recovery in the context of fewer restrictions suggest feasibility and desirability of enhanced access to take-homes without detrimental harm particularly in OTPs serving rural communities.

Assessment of the implementation of the take-home modification illuminates the potential for changing OTP policies to permit greater use of take-home medication in the future and re-evaluation of how OTPs determine patient stability. Crisis can be a tipping point for policy innovation and our results suggest that the federal regulations could be formally amended to permit more use of take-homes. The qualitative interviews provided patient perceptions and important context for the quantitative findings on the impacts of the pandemic and regulatory J o u r n a l P r e -p r o o f relaxation to reduce COVID-19 transmission risks. Qualitative analysis revealed three themes that explain and support how increased access to take-home methadone supported patient recovery.

Speculatively, the pre-COVID limitations on methadone take-home doses may not improve the quality or safety of contemporary OTP services. In fact, stricter rules may be harmful to patient recovery, as participants noted how increased responsibility with take-homes made them feel more trusted and enhanced their recovery. Strict federal and state OTP regulations could be modified to permit greater use of clinical judgement and reassessment of the take-home methadone requirements. Prior to COVID-19, at 181 days patients at OTPs became eligible for 3 take-home doses compared to the 27 they were potentially eligible for during COVID-19. On November 18, 2021, SAMHSA announced that the relaxation would be maintained for at least one year following an expiration of the pandemic public health emergency and the intent to modify the federal restrictions on take-home medication (SAMHSA, 2021) . Engaging all key stakeholders, including OTP leaders and staff who likely have unique perspectives and interests around changing federal policie,s will be important in modifying federal regulations around take-home methadone, (Levander, Pytell, et al., 2021) . Any changes in federal restrictions to take-home methadone will also need to include updates to insurance reimbursement moving from fee-for-service to bundled payments (Joseph et al., 2021) .

Changing the federal regulations would be particularly beneficial for patients in rural communities, as people with OUD in rural communities often have difficultly accessing OTPs (Joudrey et al., 2019) . Respondents noted that distance and time spent traveling to their respective clinics were significant barriers to continuing in treatment and engaging in meaningful activities such as work and spending time with family prior to the pandemic. Similarly, a systematic review of rural-specific barriers to medication treatment for OUD in the United States found that travel and time constraints presented barriers to accessing care (Lister et al., 2020) .

Our results are similar to a prior report that demonstrated that patients who received more take-J o u r n a l P r e -p r o o f Journal Pre-proof home doses felt they had fewer life disruptions than when they had to come into the clinic each day .

Our results are consistent with studies testing medically managed methadone using primary care physicians to monitor patient health and providing 27-days of methadone for selected stable patients. Novick and Joseph found that 82.5% of methadone clinic patients who were transferred to primary care and received ongoing 27-day take-homes remained in care. Similarly, Schwartz et al. (1999) showed that only 28.6% of patients withdrew from care during a 12-year study of monthly prescribed methadone by primary care physicians and the study observed no methadone-related overdose or diversion. In a study of methadone medical maintenance patients who received a 27-day supply of methadone, King et al. (2006) found that 84% of patients completed the 12-month study, patients had low rates of drug use or failed medication recall, and treatment satisfaction was high. In general, no evidence existed of diversion or return to drug use with the 27-day take-homes, and patients reported increased satisfaction with services and improved quality of life because of less restriction on work and travel. Our study found similar results as the relaxation of take-home restrictions and implementation of tele-health in response to COVID-19 did not change rates of positive UDT among OTP patients. This, together with qualitative reports of continued recovery in the context of fewer restrictions, suggests that amending federal regulations to permit more use of take-homes might be safe and merits study in broader populations. More research and outreach is needed to study patients with OUD receiving methadone who do not remain in care or who are less stable in their recovery.

Several limitations to the study may limit generalizability of the findings. The sample included a specific geographic region that lacks racial/ethnic diversity. Additionally, the study took place in two smaller OTPs with the same medical director, thus their policy responsiveness may differ from larger OTPs. The two study OTPs, moreover, operate more conservatively than J o u r n a l P r e -p r o o f Journal Pre-proof many OTPs. The OTP's administrative data were not collected for research purposes and, therefore, important measures such as patients' reasons for treatment discontinuation, methadone dosage levels, and treatment histories were not available. The OTPs in our study collected monthly UDTs, which may be different from other clinical settings given notable and public health impacts of increased access to take-homes on patients and their recovery in OUD treatment, however, remain unknown. The purpose of our study is to assess patient responses to the enhanced access to take-home methadone in two OTPs that served five Southern Oregon rural counties. 

We used a mixed methods convergent design to abstract and analyze quantitative data from electronic health records and qualitative data from semi-structured interviews with patient participants (Creswell & Creswell, 2018) . A non-profit behavioral health and primary care center operated the two OTPs. The Oregon Health and Science University Institutional Review Board approved the study as a minimal risk intervention and permitted a verbal consent process for qualitative interviews.

data on monthly urine drug screens, admission date to the OTP, number of in-clinic and take-

Journal Pre-proof home doses per month and patient demographics (e.g., age, gender, race, ethnicity) and

provided the study team with a deidentified data set (please see consort diagram, Figure 1 ). 

A case study approach using a constructivist paradigm provided the framework for the qualitative portion of the study. The study team developed research questions and an interview guide using an iterative group process to explore patient experiences and reactions to increased take-home dosing. Highly trained and experienced J o u r n a l P r e -p r o o f Journal Pre-proof qualitative researchers (KAH and XAL) conducted in-depth, semi-structured qualitative interviews with a convenience sample of 32 patient participants at the two OTPs. The interviewers did not have previous contact with the participants and built trust and rapport with participants during the informed consent process, ensuring that patients understood their responses were confidential and would not impact their relationship with the OTP or their counselor. Interviews were conducted until data saturation was achieved. Participants were compensated $40.00 following interview completion. Participants had varying take-home methadone allowances following the COVID-19 policy changes. Interviews were completed in 2 waves: 1) August-September 2020 and 2) November-December 2020 (total n=32). We conducted all interviews via phone using best practices for virtual collection of qualitative data ; interviews were audio-recorded and professionally transcribed.

We conducted a Thematic Analysis following Braun and Clark's (2006) guidelines. Three researchers (KAH, XAL, and JPT) developed a list of preliminary codes after reading interview transcripts, with codes grouped into overarching themes. Data were iteratively analyzed at the semantic level using Atlas.ti (ATLAS.ti Scientific Software Development GmbH, 2020) for data management. Two coders performed the coding (KAH and XAL). 10% of the sample was double coded to check for inter-coder agreement rat. A third coder (JPT) adjudicated the double coded sample. An inter coder agreement rate of 85% was achieved.

Overall effects. The patients were primarily non-Hispanic white (93%) women (49%) and men (51%) with a mean age of 40 years (SD = 11) and a median care duration of 532 (IQR: 257, 851) days (from treatment entry to the end of the study period. See Table 2 . Two-thirds (65%) patients were in the program at the beginning of the study period, and 47% of the initial cohort remained through the end of the study period. UDT opioid positivity by length of time in treatment, and treatment discontinuation and these results were summarized across the two periods in Table 3 (n = 377). Patients in care for more than 180 days had a significant increase in median per month take-home dosing (pre median= 8 take-homes; post median = 13 take-homes per month, p = 0.011). The proportion of positive UDT results or retention rate in treatment did not change. Patients in treatment less than 90 days did not have an increase in take-home doses and were more likely to discontinue treatment in the post-COVID period (13% discontinuation pre-COVID vs. 26% post, p = .047).

Patients in treatment for 90 to 180 days did not receive more take-homes following the takehome relaxation and their UDT opioid positivity rate increased post-COVID (19% to 33%, p = .041).

Take Homes Above Expected Analysis. The 216 patients included in the ‗take-homes above expected' analysis had more days in care than those in the overall patient population, with a median of 688 days in treatment (IQR: 482, 936). On average, these patients received 42% of their doses as take-homes pre-COVID. The take-home rated increased to 57% following the COVID-19 policy relaxation. In the mixed effects model estimating take-home doses above expected, take-home dosing increased an average of 15% (95% CI 0.11, 0.19; p < 0.001).

There was a negative relationship between the increase in take-home dosing and post-COVID policy relaxation UDT opioid positivity (B = -0.12, 95% CI -0.21, -0.04; p = 0.005). The adjusted odds of treatment discontinuation declined 0.97 for every one-percentage point increase in takehome dosing above expected (aOR = 0.97, 95% CI 0.95, 0.99; p = 0.003).

The 32 interviewed participants were non-Hispanic White (81%), women (50%) with a mean age of 42.6 years. The qualitative interviews assessed the specific aspects of methadone take-homes participants found most helpful to contextualize the quantitative findings. Overall, participants found increased take-home doses effective and acceptable without return to J o u r n a l P r e -p r o o f Journal Pre-proof substance use. Three themes emerged: 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. This sense of responsibility indicated to participants that they had grown in their recovery over time, and they felt affirmed they were on the right track:

Not to give myself a pat on the back but like compared to the beginning I must be doing well to get that many. The relaxation of take-home methadone restrictions was associated with increased distribution of take-home medication among established patients. Quantitative analyses suggested that increased take-homes did not increase, and potentially slightly decreased, use of illicit opioids and the likelihood of treatment discontinuation. We observed, however, that patients who had been in treatment for less than 90 days were more likely to discontinue treatment in the post-COVID period. Because this group saw no change in take-out dosing, this finding may be due to COVID-19 disruptions and stressors. Also of note, one OTP's patients had more days in treatment prior to the policy change, an important difference given that the literature shows better outcomes for people retained in care for longer periods (Chan et al., 2020; Sordo et al., 2017) . The OTP had been established two years prior to the other site.

These findings provide additional data on how patients adapted to COVID-19-related policy changes, the benefits and challenges with increased take-home doses, and possibilities for future directions of OTP-related regulations (Harris et al., 2021; Levander, Hoffman, et al., 2021) . Qualitative reports of continued recovery in the context of fewer restrictions suggest feasibility and desirability of enhanced access to take-homes without detrimental harm particularly in OTPs serving rural communities.

Assessment of the implementation of the take-home modification illuminates the potential for changing OTP policies to permit greater use of take-home medication in the future and re-evaluation of determination of patient stability. Crisis can be a tipping point for policy innovation and our results suggest that the federal regulations could be formally amended to permit more use of take-homes. The qualitative interviews provided patient perceptions and important context for the quantitative findings on the impacts of the pandemic and regulatory relaxation to reduce COVID-19 transmission risks. Qualitative analysis revealed three themes that explain and support how increased access to take-home methadone supported patient recovery.

J o u r n a l P r e -p r o o f (Levander, Pytell, et al., 2021) . Any changes in federal restrictions to take-home methadone will also need to include updates to insurance reimbursement moving from fee-for-service to bundled payments (Joseph et al., 2021) .

Changing the federal regulations would be particularly beneficial for patients in rural communities, as people with OUD in rural communities often have difficultly accessing OTPs (Joudrey et al., 2019) . Respondents noted that distance and time spent traveling to their respective clinics were significant barriers to continuing in treatment and engaging in meaningful activities such as work and spending time with family prior to the pandemic. Similarly, a systematic review of rural-specific barriers to medication treatment for OUD in the U.S. found that travel and time constraints presented barriers to accessing care (Lister et al., 2020) . Our results are similar to a prior report which demonstrated that patients who received more takehome doses felt they had fewer life disruptions than when they had to come into the clinic each day .

Our results are consistent with studies testing medically managed methadone using primary care physicians to monitor patient health and providing 27-days of methadone for selected stable patients. Novick and Joseph found that 82.5% of methadone clinic patients who were transferred to primary care and received ongoing 27-day take-homes remained in care. Similarly, Schwartz et al. (1999) showed that only 28.6% of patients withdrew from care during a 12-year study of monthly prescribed methadone by primary care physicians and no methadone-related overdose or diversion was observed. In a study of methadone medical maintenance patients who received a 27-day supply of methadone, King et al (2006) found that 84% of patients completed the 12-month study, there were low rates of drug use or failed medication recall, and treatment satisfaction was high. In general, there was no evidence of diversion or return to drug use with the 27-day take-homes and patients reported increased satisfaction with services and improved quality of life because of less restriction on work and travel. Our study found similar results as the relaxation of take-home restrictions and implementation of tele-health in response to COVID-19 did not change rates of positive UDT among OTP patients. This, together with qualitative reports of continued recovery in the context of fewer restrictions suggest that amending federal regulations to permit more use of takehomes might be safe and merits study in broader populations. More research and outreach is needed to study patients with OUD receiving methadone who do not remain in care or who are less stable in their recovery.

There are several limitations to the study which may limit generalizability of the findings.

The sample included a specific geographic region that lacks racial/ethnic diversity. Additionally, the study was performed in two smaller OTPs with the same medical director, thus their policy responsiveness may differ from larger OTPs. The two study OTPs, moreover, operate more conservatively than many OTPs. The OTP's administrative data was not collected for research purposes and therefore important measures such as patients' reasons treatment J o u r n a l P r e -p r o o f Journal Pre-proof discontinuation, methadone dosage levels, and treatment histories were not available. The

OTPs in our study collected monthly urine drug tests, which may be different from other clinical settings given notable regional variability in UDT guidelines. Urine drug screens are frequently used for care decisions (number of take homes), however there is needed research on correlations between urine drug testing frequency and clinical outcomes . Further research is needed to assess whether the changes seen in the initial analysis period were durable over time.

J o u r n a l P r e -p r o o f Journal Pre-proof Defined as the number of days between patient's entry into the program and the end of the study period J o u r n a l P r e -p r o o f 

United States

Qualitative Data Collection in an Era of Social Distancing

Office-Based Methadone Treatment for Opioid Use Disorder and Pharmacy Dispensing: A Scoping Review

Lacking evidence for the association between frequent urine drug screening and health outcomes of persons on opioid agonist therapy

Reduction in Oregon's Medication Dosing Visits After the SARS-CoV-2 Relaxation of Restrictions on Take-home Medication

Large Variation in Provincial Guidelines for Urine Drug Screening during Opioid Agonist Treatment in Canada

Medical maintenance: The treatment of chronic opiate dependence in general medical practice

Using thematic analysis in psychology

Retention Strategies for Medications for Addiction Treatment in Adults With Opioid Use Disorder: A Rapid Evidence Review

Research Design: Qualitative, Quantitative, and Mixed Methods Approaches

A chance to do it better: Methadone maintenance treatment in the age of Covid-19

It's like ‗liquid handcuffs‖: The effects of take-home dosing policies on Methadone Maintenance Treatment (MMT) patients' lives

-No home to take methadone to‖: Experiences with addiction services during the COVID-19 pandemic among survivors of opioid overdose in Boston

Re-thinking patient stability for methadone in opioid treatment programs during a J o u r n a l P r e -p r o o f Journal Pre-proof global pandemic: Provider perspectives

Opioid use disorder and treatment: Challenges and opportunities

Reimagining patient-centered care in opioid treatment programs: Lessons from the Bronx during COVID-19

Drive Times to Opioid Treatment Programs in Urban and Rural Counties in 5 US States

A 12-month controlled trial of methadone medical maintenance integrated into an adaptive treatment model

Rural opioid treatment program patient perspectives on take-home methadone policy changes during COVID-19

COVID-19-related policy changes for methadone take-home dosing: A multistate survey of opioid treatment program leadership

A systematic review of rural-specific barriers to medication treatment for opioid use disorder in the

United States

Qualitative Data Collection in an Era of Social Distancing

Office-Based Methadone Treatment for Opioid Use Disorder and Pharmacy Dispensing: A Scoping Review

Lacking evidence for the association between frequent urine drug screening and health outcomes of persons on opioid agonist therapy

Reduction in Oregon's Medication Dosing Visits After the SARS-CoV-2 Relaxation of Restrictions on Take-home Medication

Large Variation in Provincial Guidelines for Urine Drug Screening during Opioid Agonist Treatment in Canada

Medical maintenance: The treatment of chronic opiate dependence in general medical practice

A 12-year follow-up of a methadone medical maintenance program

Mortality risk during and after opioid substitution treatment: Systematic review and meta-analysis of cohort studies

The Impacts of COVID-19 on Mental Health, Substance Use, and Overdose Concerns of People Who Use Drugs in Rural Communities

Formal analysis: Hoffman, Cook, Foot Levander; Funding acquisition: Hoffman, McCarty, Korthuis; Investigation