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 National Brain Injury Rescue and Rehabilitation Study - a multicenter observational study of hyperbaric oxygen for mild traumatic brain injury with post-concussive symptoms.

The National Brain Injury Rescue and Rehabilitation Project was established as a preliminary study to test the safety and practicality of multi-center hyperbaric oxygen administration for the post-concussive symptoms of chronic mild traumatic brain injury as a precursor to a pivotal, independent, multi-center, controlled clinical trial. This report presents the results for 32 subjects who completed a preliminary trial of hyperbaric oxygen several years before the passage of the 21 st Century Cures Act. This study anticipated the Act and its reassessment of clinical research. Subjects received 40-82 one-hour treatments at 1.5 atmospheres absolute 100% oxygen. Outcome measures included repeated self-assessment measures and automated neurocognitive tests. The subjects demonstrated improvement in 21 of 25 neurocognitive test measures observed. The objective neurocognitive test components showed improvement in 13 of 17 measures. Earlier administration of hyperbaric oxygen post injury, younger age at the time of injury and hyperbaric oxygen administration, military status, and increased number of hyperbaric oxygen administrations were characteristics associated with improved outcomes. There were no adverse events. Hyperbaric oxygen was found to be safe, inexpensive and worthy of clinical application in the 21 st Century model of facile data collection provided by recent research regulatory shifts in medicine. The study was approved by the ethics review committee of the Western Institutional Review Board (WIRB; Protocol #20090761).

Barriers and facilitators of hepatitis C treatment uptake among people who inject drugs enrolled in opioid treatment programs in Baltimore.

BACKGROUND: Hepatitis C virus (HCV) infection is a major public health issue among people who inject drugs (PWID) with prevalence of 50-80% in the United States. Effective, simple, oral direct acting agents (DAA) of short duration with minimal side effects have been associated with cure rates > 95%. However, HCV treatment uptake among PWID remains low. We characterized the HCV care continuum, HCV treatment knowledge, as well as barriers and facilitators to HCV treatment uptake among PWID enrolled in two opioid treatment programs (OTPs) in Baltimore, Maryland, USA. METHODS: Between July and November 2016, 124 HCV infected PWID were recruited from two opioid treatment programs in Baltimore through convenience sampling. Participants completed a 50-item questionnaire to assess HCV treatment knowledge, attitudes, and practices. Progress through the HCV care continuum was assessed based on a series of questions assessing evaluation for HCV treatment, recommendation for HCV treatment by a provider, and HCV treatment initiation. HCV status was assessed based on participant self-report. RESULTS: The median age was 52 years (IQR 44-58), 56% were male, the majority were African American (69%), and 19% reported HIV coinfection. Participants had been tested for HCV at their primary care provider's (PCP's) office (34%), drug treatment center (20%), emergency room (11%), or prison (9%), and most (60%) had been diagnosed with HCV over 5 years prior. The majority reported that HCV was a major health concern for them (91%), were aware there were new treatments for HCV (89%), and that the new treatments cure most people (69%). More than half (60%) had seen a health professional who could treat HCV, 40% had HCV therapy recommended by their HCV specialist, and 20% had started or completed treatment. In univariable analysis, PWID were significantly more likely to have been treated if they were HIV co-infected (OR 3.4 (95% CI 1.3-9.2)) or had a partner or friend concerned about their HCV (OR 3.4 (95% CI 1.2-9.7)), and were significantly less likely to have been treated if they had used any illicit drugs in the preceding 6 months (OR 0.4 (95% CI 0.2-0.99). In multivariable analysis, having a friend or partner concerned about their HCV remained significantly associated with HCV treatment (OR 5.0 (95% CI 1.4-17.7)). When questioned about what would facilitate HCV treatment, the majority (85%) reported that a friend telling them that HCV treatment had helped them and having HCV treatment provided at their opioid treatment program would make them more likely to engage in HCV treatment. CONCLUSION: Despite a high prevalence of HCV among opioid treatment program patients and the availability of effective treatments, uptake remains low. We identified several key barriers and facilitators that can affect HCV treatment uptake.

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.

All the right moves: the need for the timely use of hyperbaric oxygen therapy for treating TBI/CTE/PTSD.

BACKGROUND: The modern age of hyperbaric medicine began in 1937; however, today few know about hyperbaric oxygen's effects on the body and medical conditions outside of diving medicine and wound care centers - a serious ethical issue as there are 20 US military veterans committing suicide every day directly related to Traumatic Brain Injury/Post Traumatic Stress Disorder. The problem is not whether hyperbaric oxygen is effective for treating brain injuries, but why the interference in offering this therapy to those who need it. DISCUSSION: Up against black-boxed anti-depressants that are not efficacious, it should be a "no-brainer" to use a safe, off-label drug, but in the case of military veterans, every suicide might be seen as a tremendous cost saving to certain technocrats. The unspoken rationale is that if the military were to embrace hyperbaric oxygen as the efficacious therapy that it is then current active troops that have suffered injuries will come forward and seek treatment and benefits for their Traumatic Brain Injuries now that they know there is a viable therapy and in so doing troop strength will be decimated. So, to attempt to delay the acceptance of hyperbaric oxygen the Department of Defense has funded faux-studies claiming low pressure room air to be a placebo or sham, and then proclaiming there is no statistical difference between treatment arms and sham or placebo treatment arms. With few who understand hyperbaric medicine there is almost no one to call them on this subterfuge and prevarication. Many peer-reviewed articles have been published in the last decade that demonstrate hyperbaric oxygen is effective in repairing an injured brain even long after that injury took place. One of the most notable showed that blast-induced brain injured war veterans experienced a 15 point IQ increase (p < 0.001). SUMMARY: Hyperbaric oxygen is an efficacious, benign and humanitarian way to affect brain repair but it has not been adopted because it lacks patent protection and has no large corporate sponsors. It has also met interference because other agendas are present be they the protection of the status quo, myopic budgetary constraints, or perceived liability issues.

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.

Hyperbaric oxygen therapy (1.5 ATA) in treating sports related TBI/CTE: two case reports.

Despite adequate evidence, including randomized controlled trials; hyperbaric oxygen is not yet recognized as efficacious for treating various forms of brain injury, specifically traumatic brain injury. Political-economic issues have kept this benign therapy from being widely adopted despite the lack of viable alternatives. Two football players with TBI/CTE are herewith shown to benefit from being treated with hyperbaric oxygen as documented by neurocognitive examinations and functional brain imaging, in one case treatment commenced decades after the brain injury. Perhaps the interest in HBOT by those participating in high-risk sports will help expand this orphan therapy into mainstream medicine.

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.

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.

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.