Operationalizing the new DEA exception: A novel process for dispensing of methadone for opioid use disorder at discharge from acute care settings.

PURPOSE: To describe one strategy for dispensing of methadone at emergency department (ED) and hospital discharge implemented within 2 urban academic medical centers. SUMMARY: Expanding access to medications for opioid use disorder (OUD) is a national priority. ED visits and hospitalizations offer an opportunity to initiate or continue these lifesaving medications, including methadone and buprenorphine. However, federal regulations governing methadone treatment and significant gaps in treatment availability have made continuing methadone upon ED or hospital discharge challenging. To address this issue, the Drug Enforcement Administration (DEA) granted an exception allowing hospitals, clinics, and EDs to dispense a 72-hour supply of methadone while continued treatment is arranged. Though this exception addresses a critical unmet need, guidance for operationalizing this service is limited. To facilitate expanded patient access to methadone on ED or hospital discharge at 2 Baltimore hospitals, key stakeholders within the parent health system were identified, and a workgroup was formed. Processes were established for requesting, approving, preparing, and dispensing the methadone supply using an electronic health record order set. Multidisciplinary educational materials were created to support end users of the workflow. In the first 3 months of implementation, 42 requests were entered, of which 36 were approved, resulting in 79 dispensed methadone doses. CONCLUSION: This project demonstrates feasibility of methadone dispensing at hospital and ED discharge. Further work is needed to evaluate impact on patient outcomes, such as hospital and ED utilization, length of stay, linkage to treatment, and retention in treatment.

Transitioning off methadone: A qualitative study exploring why patients discontinue methadone treatment for opioid use disorder.

INTRODUCTION: Patients who discontinue methadone for opioid use disorder are at increased risk of overdose and death. We know little about how patients make the decision to stop treatment. This study explored reasons why patients discontinue methadone treatment. METHODS: We conducted 20 individual semi-structured patient interviews and two staff focus groups, each with five participants, at two opioid treatment programs in Baltimore, MD, in the United States from June 2021 to May 2022. Patient interviews and staff focus groups covered three domains: 1) reasons why patients may want to discontinue methadone; 2) perspectives about the ideal length of methadone treatment; and 3) changes that could improve retention. We used a modified grounded theory approach to code interviews, identify emergent themes, and develop a conceptual model. RESULTS: We identified three themes related to patients' internal relationships to methadone: patients (1) viewed methadone as a bridge to opioid-free recovery, (2) believed that long-term methadone damages the body, and (3) felt that methadone increases craving for cocaine; and three themes related to their external relationships with opioid treatment programs and society at large: patients (4) viewed daily dosing as burdensome, (5) feared methadone inaccessibility could trigger relapse, and (6) experienced stigma from friends, family, and peers. Patients with internal reasons planned to stop as soon as possible and asked for education about perceived side effects and treatment for cocaine craving to promote retention. Patients with external reasons were willing to continue for longer and asked for adaptive take-home policies and reduced societal stigma around methadone. CONCLUSIONS: Patients want to discontinue methadone either because of their internal relationship to methadone and its real or perceived side effects, or because of their external experiences with opioid treatment programs and societal stigma of methadone. To improve retention, clinical and policy changes should consider responses to both of these categories of reasons.

Opioid treatment program prescribing of methadone with community pharmacy dispensing: Pilot study of feasibility and acceptability.

Access to methadone for opioid use disorder (OUD) in the United States remains limited to regulated and certified Opioid Treatment Programs (OTPs). Collaboration between OTPs and community pharmacies would increase access to and potentially satisfaction with methadone delivery. While it remains illegal for prescribers to write, and pharmacies to dispense, methadone when the indication is OUD, the present pilot study evaluates the feasibility, acceptability, and outcomes of using community pharmacies to dispense methadone prescribed by OTP physicians (in tablet formulation) to a subset of clinically stable OTP patients; all other treatment services were delivered within the OTP. Necessary Drug Enforcement Administration (DEA) exceptions for OTP prescribers and the pharmacies, along with required Substance Abuse and Mental Health Services Administration (SAMHSA) waiver for OTP participation were obtained. A final sample of 11 patients enrolled in the study and were followed for three months; one left treatment due to dissatisfaction with the tablet formulation. All remaining participants produced drug-negative urine specimens, attended all pharmacy visits and OTP counseling sessions, and completed the evaluation. Participant satisfaction was high. These findings clearly support the feasibility and acceptability of OTP physician prescribing and community pharmacy dispensing of methadone in a subset of abstinent OTP patients, and encourage full scale trials evaluating a broader array of OTPs, pharmacies and patients, in urban and, perhaps most importantly, rural settings.

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

Background: In the United States, methadone for treatment of opioid use disorder is dispensed via highly-regulated accredited opioid treatment programs (OTP). During the COVID-19 pandemic, federal regulations were loosened, allowing for greater use of take-home methadone doses. We sought to understand how OTP leaders responded to these policy changes. Methods: We distributed a multistate electronic survey from September to November 2020 of OTP leadership to members of the American Association for the Treatment of Opioid Dependence (AATOD) who self-identified as leaders of OTPs. We asked study participants about how their OTP(s) implemented COVID-19-related policy changes into their clinical practice focusing on provision of take-home methadone doses, factors used to determine patient stability, and potential concerns about increased take-home doses. We used Chi-square test to compare survey responses between characterizations of the OTPs. Results: Of 170 survey respondents (17% response rate), the majority represented leadership of for-profit OTPs (69%) and were in a Southern state (54%). Routine allowances and practices related to take-home methadone doses varied across OTPs during the COVID-19 pandemic: 80 (47%) reported 14 days for newly enrolled patients (within past 90 days), 89 (52%) reported 14 days for "less stable" patients, and 112 (66%) reported 28 days for "stable" patients. Conclusions: We found that not all eligible OTP leaders adopted the practice of routinely allowing newly enrolled, "less stable," and "stable" patients on methadone to have increased take-home doses up to the limit allowed by federal regulations during COVID-19. The pandemic provides an opportunity to critically re-evaluate long-established methadone and OTP regulations in preparation for future emergencies.

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

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.

The response of substance use disorder treatment providers to changes in macroeconomic conditions.

OBJECTIVE: To study how substance use disorder (SUD) treatment providers respond to changes in economic conditions. DATA SOURCES: 2000-2012 National Survey of Substance Abuse Treatment Services (N-SSATS) which contains detailed information on specialty SUD facilities in the United States. STUDY DESIGN: We use fixed-effects regression to study how changes in economic conditions, proxied by state unemployment rates, impact treatment setting, accepted payment forms, charity care, offered services, special programs, and use of pharmacotherapies by specialty SUD treatment providers. DATA COLLECTION: Secondary data analysis in the N-SSATS. PRINCIPAL FINDINGS: Our findings suggest a one percentage point increase in the state unemployment rate is associated with a 2.5% reduction in outpatient clients by non-profit providers and a 1.8% increase in the acceptance of private insurance as a form of payment overall. We find no evidence that inpatient treatment, the provision of charity care, offered services, or special programs are impacted by changes in the state unemployment rate. However, a one percentage point increase in the state unemployment rate leads to a 2.5% increase in the probability that a provider uses pharmacotherapies to treat addiction. CONCLUSIONS: Deteriorating economic conditions may increase financial pressures on treatment providers, prompting them to seek new sources of revenue or to change their care delivery models.

Medicaid Coverage for Methadone Maintenance and Use of Opioid Agonist Therapy in Specialty Addiction Treatment.

OBJECTIVE: This study examined differences in opioid agonist therapy (OAT) utilization among Medicaid-enrolled adults receiving public-sector opioid use disorder treatment in states with Medicaid coverage of methadone maintenance, states with block grant funding only, and states without public coverage of methadone. METHODS: Person-level treatment admission data, which included information on reason for treatment and use of OAT from 36 states were linked to state-level Medicaid policies collected in a 50-state survey. Probabilities of OAT use among Medicaid enrollees in opioid addiction treatment were calculated, with adjustment for demographic characteristics and patterns of substance use. RESULTS: In adjusted analysis, 45.0% of Medicaid-enrolled individuals in opioid addiction treatment in states with Medicaid coverage for methadone maintenance used OAT, compared with 30.1% in states with block grant coverage only and 17.0% in states with no coverage. Differences were widest in nonintensive outpatient settings. CONCLUSIONS: Medicaid methadone maintenance coverage is critical for encouraging OAT among individuals with opioid use disorders.

Characterizing smoking, cessation services, and quit interest across outpatient substance abuse treatment modalities.

The majority of individuals seeking treatment for substance use disorders are cigarette smokers, yet smoking cessation is rarely addressed during treatment. Conducting a detailed smoking-related characterization of substance abuse treatment patients across treatment modalities may facilitate the development of tailored treatment strategies. This study administered a battery of self-report instruments to compare tobacco use, quit attempts, smoking knowledge and attitudes, program services, and interest in quitting among smoking patients enrolled in opioid replacement therapy (ORT) versus non-opioid replacement (non-ORT). ORT compared with non-ORT participants smoked more heavily, had greater tobacco dependence, and endorsed greater exposure to smoking cessation services at their treatment programs. Favorable attitudes towards cessation during treatment were found within both groups. These data identify several potential clinical targets, most notably including confidence in abstaining and attitudes toward cessation pharmacotherapies that may be addressed by substance abuse treatment clinics.

Assessing traumatic event exposure: comparing the Traumatic Life Events Questionnaire to the Structured Clinical Interview for DSM-IV.

Post-traumatic stress disorder (PTSD) diagnosis requires first identifying a traumatic event, but very few studies have evaluated methods of potential traumatic event assessment and their impact on PTSD diagnosis. The authors compared a behaviorally specific comprehensive multiple-item traumatic event measure with a single-item measure to determine their impact on traumatic event identification and subsequent PTSD diagnosis. In a within-subject, counterbalanced design, the Traumatic Life Events Questionnaire (TLEQ; E. S. Kubany et al., 2000) was compared with the single-question traumatic event assessment in the Structured Clinical Interview for DSM-IV (SCID; M. B. First, R. L. Spitzer, M. Gibbon, & J. B. W. Williams, 1998) in 129 participants in opioid-dependence treatment. The TLEQ produced a 9-fold higher rate of traumatic events reported by the participants, compared with the SCID. As a result, PTSD diagnoses in the sample increased to 33% after the TLEQ measure from 24% after the SCID. The increase in potential traumatic event identification and PTSD diagnosis was greater in women than in men. This study provides strong support for the use of comprehensive traumatic event assessments to measure traumatic events and PTSD diagnoses, particularly in women.

Assessing the effectiveness of an Internet-based videoconferencing platform for delivering intensified substance abuse counseling.

Enhanced schedules of counseling can improve response to routine opioid-agonist treatment, although it is associated with increased time demands that enhance patient resistance and nonadherence. Internet-based counseling can reduce these concerns by allowing patients to participate from home. This study assesses treatment satisfaction and response to Internet-based (CRC Health Group's e-Getgoing) group counseling for partial responders to methadone maintenance treatment. Patients testing positive for an illicit substance (n = 37) were randomly assigned to e-Getgoing or onsite group counseling and followed for 6 weeks. Patients in both conditions responded favorably to intensified treatment by achieving at least 2 consecutive weeks of abstinence and 100% attendance to return to less-intensive care (e-Getgoing: 70% vs. routine: 71%, ns). Treatment satisfaction was good and comparable across conditions. E-Getgoing patients expressed a preference for the Internet-based service, reporting convenience and increased confidentiality as major reasons. Integrating Internet-based group counseling with on-site treatment services could help expand the continuum of care in methadone maintenance clinics.

Assessment and management of chronic pain in individuals seeking treatment for opioid dependence disorder.

OBJECTIVE: To review the problem of chronic pain in patients with substance use disorders, focusing on the prevalence of chronic pain in patients with substance dependence disorders, especially prescription opioid dependence, associated comorbidities, and the impact on drug abuse treatment response. METHOD: We identified relevant articles using PubMed from 1987 to 2008. Additional articles were obtained from the reference lists of key reviews of relevant topics. Studies were included if they investigated the relation between chronic pain and substance use disorders. Of particular interest were articles that proposed integrated treatment for both problems. RESULTS: The high prevalence of chronic pain syndromes was only recently explored in patients seeking treatment for drug abuse. The presence of chronic pain increases the risk of poor response to substance abuse treatment and an increased likelihood of multiple comorbidities that further add to the negative impact experienced by patients with substance dependence disorders. Substance abuse treatment programs offering integrated medical and psychiatric care for these comorbidities improve outcomes, with stepped care approaches offering the best treatment by tailoring the level of care to the individual patient's needs. CONCLUSIONS: Substance abuse treatment programs should expand their services to address the comorbidities likely to pose barriers to successful drug rehabilitation. Given the high prevalence and negative impact of chronic pain, new pain management services should be integrated within the drug treatment program and adapted as patients demonstrate the need for more intensive treatment. If applied to the problem of chronic pain, a model substance abuse treatment program of integrated stepped care would improve outcomes for patients with both devastating disorders.

Sleep problems reported by patients entering opioid agonist treatment.

Treatment-seeking opioid-dependent individuals frequently report sleep-related problems. This study provides a detailed assessment of sleep duration and quality in this population, including their effect on daily functioning and relationship to psychiatric severity and drug use. Samples of newly admitted patients to opioid agonist maintenance treatment (n = 113) completed a series of questionnaires to assess sleep functioning, psychiatric severity, and drug use due to sleep problems over the past 30 days. The results showed that study participants reported considerable sleep-related difficulties that had little effect on their appraisals of daily functioning. Nevertheless, sleep problems were associated with psychiatric distress, and those reporting substance use specifically to increase or decrease sleepiness endorsed more sleep problems and lower levels of daily functioning. Overall, these results replicate and extend previous work showing poor sleep functioning in this population and show that sleep problems are associated with variables that often have an adverse impact on substance abuse treatment outcome.

Implementing methadone medical maintenance in community-based clinics: disseminating evidence-based treatment.

Methadone medical maintenance (MMM) is an effective intervention that minimizes the demands of opioid agonist treatment without compromising good treatment response. Despite the benefits of MMM to both patients and treatment programs, little information is available to help community-based programs implement MMM and select patients who might benefit from this intervention. This study evaluates the impact of a seven-session seminar presentation combined with optional on-site consultation on subsequent changes in clinical programming and on the opinions of community-based treatment staff (n = 96) in five methadone maintenance treatment clinics regarding both the adoption of an MMM protocol and the use of an adaptive stepped care model to deliver it. The presentations were developed based on results from a randomized clinical trial (King, V. L., Kidorf, M. S., Stoller, K. B., Schwartz, R., Kolodner, K., Brooner, R. K. (2006) A 12-month controlled trial of methadone medical maintenance integrated into an adaptive treatment model. Journal of Substance Abuse Treatment 31, 385-393.) together with other studies of MMM to help program staff (a) understand the risks and benefits of MMM, (b) develop criteria to choose who may benefit from MMM, and (c) implement an adaptive stepped care delivery system that includes MMM as the least restrictive level of care. A survey of clinic staff opinion about MMM and stepped care was administered at baseline and at five other points over the course of the 1-year project. Overall, the presentations were rated highly favorable for content and presentation (3.3 on a 4-point scale). At the 12-month follow-up, staff were more likely to believe that MMM facilitates patient participation in community-based rehabilitation oriented activities (p = .026) and that MMM patients receive adequate counseling services (p = .025) and were more likely to support treatment that matches patients who are stable with minimal intensities of care (p = .041). One clinic modified its routine care to an adaptive stepped care model in response to the presentations, and 3 of the 5 clinics used MMM levels of treatment intensity at the end of the project. The results suggest that seminar presentations combined with on-site consultation may be a beneficial mechanism for helping staff at community-based programs learn about and adopt effective interventions developed and tested using rigorous research designs.

Comparing adaptive stepped care and monetary-based voucher interventions for opioid dependence.

This 6-month randomized clinical trial (with 3-month follow-up) used a 2x2 design to compare the independent and combined effectiveness of two interventions designed to improve outcomes in treatment-seeking opioid dependent patients (n=236): motivated stepped care (MSC) and contingent voucher incentives (CVI). MSC is an adaptive treatment strategy that uses principles of negative reinforcement and avoidance to motivate both attendance to varying levels of counseling services and brief periods of abstinence [Brooner, R.K., Kidorf, M., 2002. Using behavioral reinforcement to improve methadone treatment participation. Sci. Pract. Perspect. 1, 38-46; Brooner, R.K., Kidorf, M.S., King, V.L., Peirce, J.M., Bigelow, G.E., Kolodner, K., 2004. A modified "stepped care" approach to improve attendance behavior in treatment seeking opioid abusers. J. Subst. Abuse Treat. 27, 223-232]. In contrast, CVI [Higgins, S., Delaney, D.D., Budney, A.J., Bickel, W.K., Hughes, J.R., Foerg, B.A., Fenwick, J.W., 1991. A behavioral approach to achieving initial cocaine abstinence. Am. Psychiatr. 148, 1218-1224] relies on positive reinforcement to motivate drug abstinence. The results showed that the combined approach (MSC+CVI) was associated with the highest proportion of drug-negative urine samples during both the randomized and 3-month follow-up arms of the evaluation. The CVI-only and the MSC-only conditions evidenced similar proportions of drug-negative urine samples that were both significantly greater than the standard care (SC) comparison group. Voucher-based reinforcement was associated with better retention, while adaptive stepped-based care was associated with better adherence to scheduled counseling sessions. These results suggest that both CVI and MSC are more effective than routine care for reducing drug use in opioid dependent outpatients, and that the overall benefits of MSC are enhanced further by adding positive reinforcement.

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

Methadone medical maintenance (MMM) reduces the reporting schedule for stable and well-functioning methadone maintenance patients to once a month, with counseling provided by medical staff. We report on the 12-month outcomes of 92 highly stable methadone maintenance patients randomly assigned to one of three study conditions: routine care, MMM at the methadone maintenance program, and MMM at a physician's office. Methadone medical maintenance patients received a 28-day supply of methadone, whereas routine care patients received five or six take-home methadone doses each week. All patients performed a medication recall once a month and submitted two urine samples each month. An adaptive stepped-care system of treatment intensification was used for patients who failed recall or who had drug-positive urine specimens. Seventy-seven patients completed the 12-month study period. Dropout was caused primarily by problems with handling methadone and disliking the recall frequency. There were low rates of drug use or failed medication recall. Treatment satisfaction was high in all groups, but the MMM patients initiated more new employment or family/social activities than did routine care patients over the study period. The stepped-care approach was well tolerated and matched patients to an appropriate step of service within a continuum of treatment intensity.

Involving significant others in the care of opioid-dependent patients receiving methadone.

Positive, abstinence-oriented, social support is associated with good substance abuse treatment outcome but few interventions are designed to help patients improve their social supports. This article reports on a behavioral intervention designed to encourage opioid-dependent patients receiving methadone to include drug-free family members or friends in treatment and to use these individuals to facilitate development of a supportive, non-drug-using social network. This report uses data from a quality assurance program review of the treatment response of 59 opioid-dependent outpatients who identified a drug-free significant other to participate in their treatment. Fifty-five (93.2%) brought a significant other (most often the patient's mother, 29%) to both the initial evaluation session and at least one joint session. Social support activities were family- (33%), church- (28%), and self-help group-related (30%). Approximately 78% of patients who participated in the social support intervention achieved at least four consecutive weeks of abstinence. Women responded better than men. We conclude that methadone-maintained patients can and will include non-drug-using family members and friends in treatment, and these individuals can be mobilized to help patients improve their recovery.

Behavioral contingencies improve counseling attendance in an adaptive treatment model.

Poor patient adherence remains a serious obstacle to improving the effectiveness of many drug abuse therapies and the overall quality of care delivered in programs. The present study evaluated the utility and efficacy of incorporating behavioral contingencies in a stepped care treatment approach to motivate patient attendance to the varying amounts of prescribed weekly counseling. Study participants were opioid-dependent patients (n = 127) newly admitted to an ambulatory treatment program that provides methadone. Participants were randomly assigned to a Motivated Stepped Care condition (MSC; n = 65) with behavioral contingencies to specifically motivate counseling attendance vs. a Standard Stepped Care condition (SSC; n = 62) without these contingencies. The MSC vs. SSC condition was associated with a higher rate of counseling attendance (83% vs. 44%, p < .001) and a lower rate of poor treatment response (46% vs. 79%, p < .001). The behavioral contingencies were well tolerated and strongly associated with excellent attendance across both lower and higher doses of weekly counseling.