Randomized trial of methadone treatment of arrestees: 24-month post-release outcomes.

BACKGROUND: We report on the 24-month post-release outcomes of arrestees with opioid use disorder (OUD) enrolled in a randomized trial comparing three treatment approaches initiated in jail. METHODS: Adults (N = 225) receiving medically supervised withdrawal from opioids in the Baltimore Detention Center within a few days of arrest were randomly assigned to: (1) interim methadone treatment plus patient navigation (IM + PN) started in the Detention Center; (2) IM; or (3) Enhanced Treatment-as-Usual (ETAU) consisting of detoxification with methadone and referral to treatment in the community. Participants in both methadone conditions could transfer to standard methadone treatment following release. Participants were interviewed at baseline, and 1, 3, 6, 12, and 24 months post-release. Urine was drug tested at follow-up and official arrest records were obtained. RESULTS: On an intention-to-treat basis, there were no significant differences among the three conditions over the 24-month post-release period in terms of opioid- or cocaine-positive urine test results or self-reported opioid or cocaine use, meeting opioid or cocaine use disorder criteria, self-reported criminal behavior, or the number of official arrests. There were 9 fatal overdoses, none occurring during methadone treatment, and 109 hospitalizations unrelated to the study. CONCLUSIONS: Given the high morbidity and mortality found in this population of arrestees and costs to society associated with their health care utilization and continued crime and arrests, research aimed at finding more effective interventions should be continued. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02334215.

Impact of methadone treatment initiated in jail on subsequent arrest.

BACKGROUND: There are limited data from randomized trials about the impact of starting methadone treatment in jail on subsequent arrest after release for adults with opioid use disorder (OUD). METHODS: Official arrest records were obtained for 212 participants with OUD who were enrolled in a three-group randomized controlled trial of initiating methadone treatment in jail either with or without patient navigation vs. enhanced treatment-as-usual in Baltimore, Maryland. Participants treated for opioid withdrawal in jail were assigned to: 1) interim methadone (IM) with patient navigation (PN; IM + PN); 2) IM without PN (IM); or 3) enhanced treatment-as-usual (ETAU). Participants in both IM groups were able to continue treatment at a community-based methadone treatment program with counseling upon release, while ETAU participants received overdose information and a city-wide treatment assessment/referral number. Likelihood of arrest, time to first subsequent arrest, and severity of arrest charges in the 12 months following release were examined for: 1) combined IM + PN and IM groups compared to ETAU; and 2) IM + PN compared to IM. RESULTS: Within 12 months of release from the index incarceration, 50.5% of the sample had been arrested. The majority of arrest charges (71%) were for low-level, nonviolent crimes. On an intention-to-treat basis, there were no significant differences between the combined IM + PN and IM groups vs. ETAU or IM + PN vs. IM in the likelihood of arrest, time to first subsequent arrest, or severity of arrest charges. CONCLUSION: Initiating IM with or without PN during pretrial detention did not have a significant effect on subsequent arrest during a 12-month post-release follow-up compared to not starting methadone maintenance during detention, despite the high rate of methadone treatment entry in the community following release. This finding may be attributable to the considerable attrition from treatment in the community or other systematic factors. Additional interventions may be needed to reduce the likelihood of subsequent arrest.

Leveraging health information exchange for clinical research: Extreme underreporting of hospital service utilization among patients with substance use disorders.

BACKGROUND: Substance use disorders are associated with inefficient and fragmented use of healthcare services. The Chesapeake Regional Information System for Our Patients, Inc. (CRISP) is a Health Information Exchange (HIE) linking disparate systems of care in the mid-Atlantic region. METHODS: This article describes applications of HIE for tracking hospital service utilization in substance use disorder clinical and services research, drawing upon data from one of the first studies approved to access the CRISP HIE. Participants were 200 medical/surgical inpatients with comorbid opioid, cocaine, and/or alcohol use disorder (45.5 % female; 56.5 % black; 77.5 % opioid use disorder; 42.0 % homeless). This study compared HIE-identified hospital service utilization with conventional methods of participant self-report during in-person research follow-ups (3-, 6-, and 12-months post-discharge) and electronic health record (EHR) review from the hospital system of the index admission. RESULTS: This sample exhibited high levels of hospital utilization, which would have been underestimated using conventional methods. Relying exclusively on self-report in the 12-month observation period would have identified only 33.8 % of 429 inpatient hospitalizations and 9.0 % of 1,287 ED visits, due to both loss-to-follow-up and failure to report events. Even combining self-report with single-system EHR review identified only 66.2 % of inpatient hospitalizations and 59.8 % of ED visits. CONCLUSIONS: CRISP HIE data were superior to conventional methods for ascertaining hospital service utilization in this sample of patients exhibiting high-volume and fragmented care. The use of HIE holds implications for improving rigor, safety, and efficiency in research studies.

Initiating methadone in jail and in the community: Patient differences and implications of methadone treatment for reducing arrests.

The extent to which patient characteristics differ between individuals entering methadone treatment through community programs and jail-based programs is not known. Such differences could impact the likelihood of relapse and recidivism in these two populations and inform efforts at targeting interventions. We compared treatment-entry characteristics of participants enrolling in methadone treatment in two studies conducted in Baltimore, one conducted in community programs (N = 295) and the other in a jail-based program (N = 225). Controlling for age, race, and gender, individuals starting methadone treatment in jail compared to the community, had more severe drug use and criminal justice profiles. These different characteristics suggest that patients initiating methadone in a jail-based program could have greater likelihood of future arrest compared to patients entering community-based treatment. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT 02334215 and NCT 01442493.

Pharmacotherapy for opioid addiction in community corrections.

Pharmacotherapy for opioid addiction with methadone, buprenorphine, and naltrexone has proven efficacy in reducing illicit opioid use. These treatments are under-utilized among opioid-addicted individuals on parole, probation, or in drug courts. This paper examines the peer-reviewed literature on the effectiveness of pharmacotherapy for opioid addiction of adults under community-based criminal justice supervision in the US. Compared to general populations, there are relatively few papers addressing the separate impact of pharmacotherapy on individuals under community supervision. Tentative conclusions can be drawn from the extant literature. Reasonable evidence exists that illicit opioid use and self-reported criminal behaviour decline after treatment entry, and that these outcomes are as favourable among individuals under criminal justice supervision as the general treatment population. Surprisingly, there is no conclusive evidence regarding the extent to which pharmacotherapy impacts the likelihood of arrest and incarceration among individuals under supervision. However, given the proven efficacy of these three medications in reducing illicit opioid use and the evidence that, in the general population, methadone and buprenorphine treatment are associated with reduction in overdose mortality, the use of all three pharmacotherapies among patients under criminal justice supervision should be expanded while more data are collected on their impact on arrest and incarceration.

Treatment outcomes among a cohort of African American buprenorphine patients: Follow-up at 12 months.

BACKGROUND: Although buprenorphine/naloxone (bup/nal) is well-established as a safe and effective treatment for opioid use disorders (OUDs), there are few studies reporting 12-month outcomes of patients receiving bup/nal in formerly drug-free outpatient programs. OBJECTIVES: To examine 12-month outcomes by bup/nal treatment enrollment status among a cohort of African American patients enrolled in a clinical trial. METHODS: This analysis builds upon a randomized trial of 300 opioid-dependent African American bup/nal patients in two outpatient programs in Baltimore, MD. A subset of participants (N = 133, n = 47 female) were tracked for a 12-month follow-up interview. RESULTS: The participants receiving bup/nal at 12 months had significantly fewer opioid-positive urine screens (44% v. 73%) and days of self-reported heroin use (M [SE] = 1.13 [.34] v. 7.12 [1.44]) than the out-of-bup/nal-treatment group (both ps ≤ .001). Similarly, those receiving bup/nal reported significantly fewer days of cocaine use (M [SE] = 0.85 [0.23] v. 2.88[0.75]) and alcohol use (M [SE] = 1.44 [0.38] v. 3.69 [1.04]; both ps<.05). There were no significant differences related to criminal activity, quality of life, and most ASI composite scores. Models adjusting for the baseline value, prior treatment experience, and assigned study condition largely confirmed these findings, except that participants in treatment had fewer days of crime and higher psychological quality of life scores compared to those out-of-treatment. CONCLUSIONS: Those receiving bup/nal at 12 months had significantly lower rates of illicit opioid use than those who were not. Approaches to improve bup/nal treatment retention and reengagement of patients with OUD are needed.

Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles.

Conflicts with methadone program counseling staff and violations of program rules can contribute to patients leaving treatment prematurely. This qualitative study was conducted as part of a larger trial of patient-centered methadone treatment (PCM). In-depth, semi-structured interviews at baseline and 12-month follow-up were conducted with five counselors and three clinical supervisors from the programs participating in the PCM parent study. Data were analyzed using Atlas.ti. Counselors reported that, in some cases, PCM allowed them to focus on building a therapeutic alliance with patients because they were not addressing program rule issues. Some reported using more pro-active, innovative strategies for engaging PCM patients and that counseling sessions tended to include a broader range of individually tailored topics, compared to topics normally addressed in typical treatment sessions. Adjusting to the new counselor role was challenging for some counselors and required a shift in tactics to encourage patients' participation in counseling services. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT 01442493.

When does methadone treatment reduce arrest and severity of arrest charges? An analysis of arrest records.

This is an analysis of the odds of arrest, severity of charges, and factors predicting these outcomes in the year after methadone treatment entry using arrest records of patients (N=289) participating in two opioid treatment programs (OTPs) in Baltimore, MD as part of a previously-reported study. Baseline Addiction Severity Index data were examined along with publicly-available dates of arrest and arrest charges from the year before and after OTP entry. Severity of charges was rated independently by three researchers using a 1-7 point scale. Data were analyzed using Generalized Estimating Equations and Multiple Regression. The majority of the patients had no arrests over both time periods (61.6% and 65.7%, respectively). Of those arrested, the majority of the sample were charged with non-severe crimes in the year before and after OTP entry (82.9% and 73.7%, respectively). There were no significant differences in the odds of arrest or severity of charges in the year before versus the year after OTP admission (both ps>0.05). Predictors of arrest following admission included an arrest in the year prior to admission (p<0.001), younger age (p<0.001), and more lifetime months of incarceration (p=0.045). Predictors of the higher severity of charges included younger age (p<0.001), African-American race (p=0.032), and more lifetime months of incarceration (p=0.018). While in this population, the odds of arrest and severity of charges did not decrease significantly in the year following OTP entry, we discuss the need to avoid generalizing findings without considering those factors that may influence the likelihood of post-OTP entry arrest.

Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations.

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD. PERSPECTIVE: Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation.

Patient-centered methadone treatment: a randomized clinical trial.

BACKGROUND AND AIMS: Methadone patients who discontinue treatment are at high risk of relapse, yet a substantial proportion discontinue treatment within the first year. We investigated whether a patient-centered approach to methadone treatment improved participant outcomes at 12 months following admission, compared with methadone treatment-as-usual. DESIGN: Two-arm open-label randomized trial. SETTING: Two methadone treatment programs (MTPs) in Baltimore, MD, USA. PARTICIPANTS: Three hundred newly admitted MTP patients were enrolled between 13 September 2011 and 26 March 2014. Their mean age was 42.7 years [standard deviation (SD) = 10.1] and 59% were males. INTERVENTION: Newly admitted MTP patients were assigned randomly to either patient-centered methadone treatment (PCM; n = 149), which modified the MTP's rules (e.g. counseling attendance was optional), and counselor roles (e.g. counselors were not responsible for enforcing clinic rules) or treatment-as-usual (TAU; n = 151). MEASUREMENTS: The primary outcome was opioid-positive urine test at 12-month follow-up. Other 12-month outcomes included days of heroin and cocaine use, cocaine-positive urine tests, meeting DSM-IV opioid and cocaine dependence diagnostic criteria, HIV risk behavior and quality of life and retention in treatment. FINDINGS: There was no significant difference between PCM and TAU conditions in opioid-positive urine screens at 12 months [adjusted odds ratio = 0.98; 95% confidence interval (CI) = 0.61, 1.56]. There were also no significant differences in any of the secondary outcome measures (all Ps > 0.05) except Quality of Life Global Score (P = 0.04; 95% CI = 0.01, 0.45). There were no significant differences between conditions in the number of individual or group counseling sessions attended. (Ps > 0.05). CONCLUSIONS: Patient-centered methadone treatment (with optional counseling and the counselor not serving as the treatment program disciplinarian) does not appear to be more effective than methadone treatment-as-usual.

Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial.

BACKGROUND: Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. METHODS: This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. RESULTS: We describe the background and rationale for the study, its aims, hypotheses, and study design. CONCLUSIONS: Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. ClinicalTrials.gov: NCT02334215.

Understanding Patterns Of High-Cost Health Care Use Across Different Substance User Groups.

Substance use contributes to significant societal burdens, including high-cost health care use. However, these burdens may vary by type of substance and level of involvement. Using the 2009-13 National Surveys on Drug Use and Health, we examined all-cause hospitalizations and estimated costs across substance use profiles for alcohol, marijuana, and other illicit drugs. For each substance, we characterized differences between abstainers, nondiagnostic users (people who used the substance but did not meet diagnostic criteria for substance use disorder), and people with substance use disorders. In a multivariate analysis, we found that the odds of hospitalization were 16 percent lower for nondiagnostic marijuana users and 11 percent lower for nondiagnostic alcohol users, compared to abstainers. Neither alcohol- nor marijuana-specific substance use disorders were associated with hospitalization. In contrast, substance use disorders for other illicit drugs were strongly associated with hospitalization: People with those disorders had 2.2 times higher odds of hospitalization relative to abstainers. A more detailed understanding of health care use in different substance user groups could inform the ongoing expansion of substance use services in the United States.

Buprenorphine dose induction in non-opioid-tolerant pre-release prisoners.

BACKGROUND: In a previously reported randomized controlled trial, formerly opioid-dependent prisoners were more likely to enter community drug abuse treatment when they were inducted in prison onto buprenorphine/naloxone (hereafter called buprenorphine) than when they received counseling without buprenorphine in prison (47.5% vs. 33.7%, p=0.012) (Gordon et al., 2014). In this communication we report on the results of the induction schedule and the adverse event profile seen in pre-release prisoners inducted onto buprenorphine. METHOD: This paper examines the dose induction procedure, a comparison of the proposed versus actual doses given per week, and side effects reported for 104 adult participants who were randomized to buprenorphine treatment in prison. Self-reported side effects were analyzed using generalized estimated equations to determine changes over time in side effects. RESULTS: Study participants were inducted onto buprenorphine at a rate faster than the induction schedule. Of the 104 (72 males, 32 females) buprenorphine recipients, 64 (37 males, 27 females) remained on medication at release from prison. Nine participants (8.6%) discontinued buprenorphine because of unpleasant opioid side effects. There were no serious adverse events reported during the in-prison phase of the study. Constipation was the most frequent symptom reported (69 percent). CONCLUSION: Our findings suggest that buprenorphine administered to non-opioid-tolerant adults should be started at a lower, individualized dose than customarily used for adults actively using opioids, and that non-opioid-tolerant pre-release prisoners can be successfully inducted onto therapeutic doses prior to release.

Heroin Use, HIV-Risk, and Criminal Behavior in Baltimore: Findings from Clinical Research.

This article reviews research conducted in Baltimore over the past 15 years, examining the following: (1) What factors differentiate heroin-addicted individuals who enter methadone treatment from those who do not? (2) How difficult is gaining access to methadone treatment? (3) What are effective ways to overcome barriers to treatment entry? (4) Why do so many methadone patients drop out of treatment prematurely? (5) What are the added benefits of counseling when coupled with methadone or buprenorphine treatment? (6) Does increasing access to treatment have an impact on overdose deaths? Specific recommendations are made for policymakers concerned with addressing heroin addiction.

Changes in Quality of Life following Buprenorphine Treatment: Relationship with Treatment Retention and Illicit Opioid Use.

Studies of substance abuse treatment outcomes that give priority to cessation of all drug use may obscure other tangible benefits of treatment that are important to patients. The aim of this study was to examine the association between changes in quality of life (QoL) and: (1) retention in treatment; and (2) opioid use as measured by self-report and urine testing. Participants were 300 African American men and women starting outpatient buprenorphine treatment. Participants completed assessments at baseline, three and six months consisting of the World Health Organization's Quality of Life brief scale, Addiction Severity Index, and urine testing for opioids. There were statistically significant increases over time across all four QoL domains: physical, psychological, environmental, and social. Self-reported frequency of opioid use was negatively associated with psychological QoL, but opioid urine test results were not significantly associated with any QoL domains. Continued treatment enrollment was significantly associated with higher psychological QoL and environmental QoL. Patients entering buprenorphine treatment experience improvements in QoL, which are amplified for patients who remain in treatment. Point-prevalence opiate urine test results obtained at each assessment were not associated with any of the QoL domains and may not accurately reflect improvements perceived by patients receiving buprenorphine treatment.

Buprenorphine Treatment and 12-step Meeting Attendance: Conflicts, Compatibilities, and Patient Outcomes.

This analysis examines patient experiences and outcomes with 12-step recovery group attendance during buprenorphine maintenance treatment (BMT), two approaches with traditionally divergent philosophies regarding opioid medications for treatment of opioid use disorder. Using quantitative (n = 300) and qualitative (n = 20) data collected during a randomized trial of counseling services in buprenorphine treatment, this mixed-methods analysis of African Americans in BMT finds the number of NA meetings attended in the prior 6 months was associated with a higher rate of retention in BMT (p < .001) and heroin/cocaine abstinence at 6 month follow-up (p = .005). However, patients whose counselors required them to attend 12-step meetings did not have better outcomes than patients not required to attend such meetings. Qualitative narratives highlighted patients' strategies for managing dissonant viewpoints on BMT and disclosing BMT status in community 12-step meetings. Twelve-step meeting attendance is associated with better outcomes for BMT patients over the first 6 months of treatment. However, there is no benefit to requiring meeting attendance as a condition of treatment, and clinicians should be aware of potential philosophical conflicts between 12-step and BMT approaches.