The Medications for Opioid Use Disorder Study: Methods and Initial Outcomes From an 18-Month Study of Patients in Treatment for Opioid Use Disorder.

OBJECTIVE: Opioid use disorder (OUD) affects approximately 5.6 million people in the United States annually, yet rates of the use of effective medication for OUD (MOUD) treatment are low. We conducted an observational cohort study from August 2017 through May 2021, the MOUD Study, to better understand treatment engagement and factors that may influence treatment experiences and outcomes. In this article, we describe the study design, data collected, and treatment outcomes. METHODS: We recruited adult patients receiving OUD treatment at US outpatient facilities for the MOUD Study. We collected patient-level data at 5 time points (baseline to 18 months) via self-administered questionnaires and health record data. We collected facility-level data via questionnaires administered to facility directors at 2 time points. Across 16 states, 62 OUD treatment facilities participated, and 1974 patients enrolled in the study. We summarized descriptive data on the characteristics of patients and OUD treatment facilities and selected treatment outcomes. RESULTS: Approximately half of the 62 facilities were private, nonprofit organizations; 62% focused primarily on substance use treatment; and 20% also offered mental health services. Most participants were receiving methadone (61%) or buprenorphine (32%) and were predominately non-Hispanic White (68%), aged 25-44 years (62%), and female (54%). Compared with patient-reported estimates at baseline, 18-month estimates suggested that rates of abstinence increased (55% to 77%), and rates of opioid-related overdoses (7% to 2%), emergency department visits (9% to 4%), and arrests (15% to 7%) decreased. CONCLUSIONS: Our results demonstrated the benefits of treatment retention not only on abstinence from opioid use but also on other quality-of-life metrics, with data collected during an extended period. The MOUD Study produced rich, multilevel data that can lay the foundation for an evidence base to inform OUD treatment and support improvement of care and patient outcomes.

Health care use and cost of treatment for adolescents and young adults with opioid use disorder.

BACKGROUND: Few studies have examined the cost of medication for opioid use disorder (MOUD) with counseling for the adolescent and young adult population. This study calculated the health care utilization and cost of MOUD treatment, other substance use disorder treatment, and general health care for adolescents and young adults receiving treatment for opioid use disorder. METHODS: The study randomized youth ages 15 to 21 (N = 288) equally into the two study conditions: extended-release naltrexone (XR-NTX) or treatment as usual (TAU). While participants committed to treatment based on randomization the study observed considerable nonadherence to both randomized conditions. Instead of using the randomly assigned study conditions, we present descriptive costs by the type of MOUD treatment received: XR-NTX only, buprenorphine only, any other combination of MOUD treatments, and no MOUD. Health care use was aggregated over the 6-month period for each participant, and we calculated average/participant utilization for each treatment group. To determine participant costs, we multiplied the unit costs of health care services obtained from the literature by the reported amount of health care utilization for each participant. We then calculated the mean, standard error, median and IQR for MOUD costs, other substance use disorder treatment costs and general healthcare cost from the health care sector perspective. RESULTS: On average, participants in the XR-NTX only group received 2.6 doses of XR-NTX (equivalent to approximately 78 days of treatment). The buprenorphine only group had an average of 97 days of buprenorphine treatment. The XR-NTX only group had higher/patient costs compared to participants in the buprenorphine only group ($10,491 vs. $8765) and higher XR-NTX utilization would further increase costs. Participants in the any other MOUD combination group had the highest total costs ($14,627) while participants in the no MOUD group at the lowest ($3453). DISCUSSION: Our cost analysis calculates the real-world cost of MOUD treatment and, while not generalizable, provides policy makers an estimate of costs for adolescents and young adults. We found that participants in the XR-NTX only group received fewer days of medication compared to the buprenorphine only group, but their medication costs were higher due to the cost of XR-NTX injections. While the buprenorphine only group had the highest number of days of medication utilization of all the groups, the average number of days of medication utilization was considerably shorter than the six-month treatment period.

Cost and cost-effectiveness of abstinence contingent wage supplements.

BACKGROUND: Substance use disorders are correlated with unemployment and poverty. However, few interventions aim to improve substance use, unemployment, and, distally, poverty. The Abstinence-Contingent Wage Supplement (ACWS) randomized controlled trial combined a therapeutic workplace with abstinence-contingent wage supplements to address substance use and unemployment. The ACWS study found that abstinence-contingent wage supplements increased the percentage of participants who had negative drug tests, who were employed, and who were above the poverty line during the intervention period. This study presents the cost of ACWS and calculates the cost-effectiveness of ACWS compared with usual care. METHODS: To calculate the cost and cost-effectiveness of ACWS, we used activity-based costing methods to cost the intervention and calculated the costs from the provider and healthcare sector perspective. We calculated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves for negative drug tests and employment. RESULTS: ACWS cost $11,310 per participant over the 12-month intervention period. Total intervention and healthcare costs per participant over the intervention period were $20,625 for usual care and $30,686 for ACWS. At the end of the intervention period an additional participant with a negative drug test cost $1437 while an additional participant employed cost $915. CONCLUSIONS: ACWS increases drug abstinence and employment and may be cost-effective at the end of the 12-month intervention period if decision makers are willing to pay the incremental cost associated with the intervention.

Economic Evaluation Design within the HEAL Prevention Cooperative.

The rapid rise in opioid misuse, disorder, and opioid-involved deaths among older adolescents and young adults is an urgent public health problem. Prevention is a vital part of the nation's response to the opioid crisis, yet preventive interventions for those at risk for opioid misuse and opioid use disorder are scarce. In 2019, the National Institutes of Health (NIH) launched the Preventing Opioid Use Disorder in Older Adolescents and Young Adults cooperative as part of its broader Helping to End Addiction Long-term (HEAL) Initiative ( https://heal.nih.gov/ ). The HEAL Prevention Cooperative (HPC) includes ten research projects funded with the goal of developing effective prevention interventions across various settings (e.g., community, health care, juvenile justice, school) for older adolescent and young adults at risk for opioid misuse and opioid use disorder (OUD). An important component of the HPC is the inclusion of an economic evaluation by nine of these research projects that will provide information on the costs, cost-effectiveness, and sustainability of these interventions. The HPC economic evaluation is integrated into each research project's overall design with start-up costs and ongoing delivery costs collected prospectively using an activity-based costing approach. The primary objectives of the economic evaluation are to estimate the intervention implementation costs to providers, estimate the cost-effectiveness of each intervention for reducing opioid misuse initiation and escalation among youth, and use simulation modeling to estimate the budget impact of broader implementation of the interventions within the various settings over multiple years. The HPC offers an extraordinary opportunity to generate economic evidence for substance use prevention programming, providing policy makers and providers with critical information on the investments needed to start-up prevention interventions, as well as the cost-effectiveness of these interventions relative to alternatives. These data will help demonstrate the valuable role that prevention can play in combating the opioid crisis.

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population.

BACKGROUND: A randomized clinical trial found that patient navigation for hospital patients with comorbid substance use disorders (SUDs) reduced emergency department (ED) and inpatient hospital utilization compared with treatment-as-usual. OBJECTIVE: To compare the cost and calculate any cost savings from the Navigation Services to Avoid Rehospitalization (NavSTAR) intervention over treatment-as-usual. RESEARCH DESIGN: This study calculates activity-based costs from the health care providers and uses a net benefits approach to calculate the cost savings generated from NavSTAR. NavSTAR provided patient navigation focused on engagement in SUD treatment, starting before hospital discharge and continuing for up to 3 months postdischarge. SUBJECTS: Adult hospitalized medical/surgical patients with comorbid SUD for opioids, cocaine, and/or alcohol. COST MEASURES: Cost of the 3-month NavSTAR patient navigation intervention and the cost of all inpatient days and ED visits over a 12-month period. RESULTS OF BASE CASE ANALYSIS: NavSTAR generated $17,780 per participant in cost savings. Ninety-seven percent of bootstrapped samples generated positive cost savings, and our sensitivity analyses did not change our results. LIMITATIONS: Participants were recruited at one hospital in Baltimore, MD through the hospital's addiction consultation service. Findings may not generalize to the broader population. Outpatient health care cost data was not available through administrative records. CONCLUSION: Our findings show that patient navigation interventions should be considered by payors and policy makers to reduce the high hospital costs associated with comorbid SUD patients.

Cost and Cost-Effectiveness of Incentives for Viral Suppression in People Living with HIV.

Only 63% of people living with HIV in the United States are achieving viral suppression. Structural and social barriers limit adherence to antiretroviral therapy which furthers the HIV epidemic while increasing health care costs. This study calculated the cost and cost-effectiveness of a contingency management intervention with cash incentives. People with HIV and detectable viral loads were randomized to usual care or an incentive group. Individuals could earn up to $3650 per year if they achieved and maintained an undetectable viral load. The average 1-year intervention cost, including incentives, was $4105 per patient. The average health care costs were $27,189 per patient in usual care and $35,853 per patient in the incentive group. We estimated a cost of $28,888 per quality-adjusted life-year (QALY) gained, which is well below accepted cost-per-QALY thresholds. Contingency management with cash incentives is a cost-effective intervention for significantly increasing viral suppression.

A National Cost Analysis of Community Interventions to Prevent Underage Drinking and Prescription Drug Misuse.

This prospective cost analysis addresses a gap in the prevention literature by providing estimates of the typical real-world costs to implement community interventions focused on preventing underage drinking and prescription drug misuse. The study uses cost data reported by more than 400 community subrecipients participating in a national cross-site evaluation of the Substance Abuse and Mental Health Services Administration's Strategic Prevention Framework Partnerships for Success grant program during 2013-2017. Community subrecipient organizations completed an annual Web-based survey to report their intervention costs. The analysis compares the relative startup and annual ongoing implementation costs of different prevention strategies and services. Partnerships for Success communities implemented a wide variety of interventions. Annual ongoing implementation was typically more costly than intervention startup. Costs were generally similar for population-level interventions, such as information dissemination and environmental strategies, and individual-level interventions, such as prevention education and positive alternative activities. However, population-level interventions reached considerably more people and consequently had much lower costs per person. Personnel contributed the most to intervention costs, followed by intervention supplies and overhead. Startup costs for initial training and costs for incentives, ongoing training, and in-kind contributions (nonlabor) during ongoing implementation were not typically reported. This study informs prevention planning by providing detailed information about the costs of classes of interventions used in communities, outside of research settings.

Minimal-Contact Versus Standard Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Cost-Effectiveness Results of a Multisite Trial.

BACKGROUND: Irritable bowel syndrome (IBS) is a common, often disabling gastrointestinal (GI) disorder for which there is no satisfactory medical treatment but is responsive to cognitive behavior therapy (CBT). PURPOSE: To evaluate the costs and cost-effectiveness of a minimal contact version of CBT (MC-CBT) condition for N = 145 for IBS relative to a standard, clinic-based CBT (S-CBT; N = 146) and a nonspecific comparator emphasizing education/support (EDU; N = 145). METHOD: We estimated the per-patient cost of each treatment condition using an activity-based costing approach that allowed us to identify and estimate costs for specific components of each intervention as well as the overall total costs. Using simple means analysis and multiple regression models, we estimated the incremental effectiveness of MC-CBT relative to S-CBT and EDU. We then evaluated the cost-effectiveness of MC-CBT relative to these alternatives for selected outcomes at immediate posttreatment and 6 months posttreatment, using both an intent-to-treatment and per-protocol methodology. Key outcomes included scores on the Clinical Global Impressions-Improvement Scale and the percentage of patients who positively responded to treatment. RESULTS: The average per-patient cost of delivering MC-CBT was $348, which was significantly less than the cost of S-CBT ($644) and EDU ($457) (p < .01). Furthermore, MC-CBT produced better average patient outcomes at immediate and 6 months posttreatment relative to S-CBT and EDU (p < .01). The current findings indicated that MC-CBT is a cost-effective option relative to S-CBT and EDU. CONCLUSION: As predicted, MC-CBT was delivered at a lower cost per patient than S-CBT and performed better over time on the primary outcome of global IBS symptom improvement.

Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.

BACKGROUND: Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group. METHODS: We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective. RESULTS: The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs. CONCLUSIONS: IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.

Group Versus Standard Behavioral Couples' Therapy for Alcohol Use Disorder Patients: Cost-Effectiveness.

OBJECTIVE: The purpose of this study was to evaluate the costs and cost-effectiveness of two treatments for 101 alcohol use disorder patients and their intimate partners--group behavioral couples' therapy plus individual-based treatment (G-BCT), or standard behavioral couples' therapy plus individual-based treatment (S-BCT). METHOD: We estimated the per-patient cost of each intervention using a microcosting approach that allowed us to estimate costs of specific components in each intervention as well as the overall total costs. Using simple means analysis and multiple regression models, we estimated the incremental effectiveness of G-BCT relative to S-BCT. Immediately after treatment and 12 months after treatment, we computed incremental cost-effectiveness ratios (ICER) and cost-effectiveness acceptability curves for percentage days abstinent, adverse consequences of alcohol and drugs, and overall relationship functioning. RESULTS: The average per-patient cost of delivering G-BCT was $674, significantly less than the cost of S-BCT ($831). However, 12 months after treatment, S-BCT participants performed better on all outcomes compared with those in G-BCT, and the calculated ICER moving from G-BCT to S-BCT ranged from $10 to $12 across these outcomes. The current findings indicated that, except at very low willingness-to-pay values, S-BCT is a cost-effective option relative to G-BCT when considering 12-month posttreatment outcomes. CONCLUSIONS: As expected, G-BCT was delivered at a lower cost per patient than S-BCT; however, S-BCT performed better over time on the clinical outcomes studied. These economic findings indicate that alcohol use disorder treatment providers should seriously consider S-BCT over G-BCT when deciding what format to use in behavioral couples' therapy.

Screening and Intervention for Suicide Prevention: A Cost-Effectiveness Analysis of the ED-SAFE Interventions.

OBJECTIVE: Suicide screening followed by an intervention may identify suicidal individuals and prevent recurring self-harm, but few cost-effectiveness studies have been conducted. This study sought to determine whether the increased costs of implementing screening and intervention in hospital emergency departments (EDs) are justified by improvements in patient outcomes (decreased attempts and deaths by suicide). METHODS: The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) study recruited participants in eight U.S. EDs between August 2010 and November 2013. The eight sites sequentially implemented two interventions: universal screening added to treatment as usual and universal screening plus a telephone-based intervention delivered over 12 months post-ED visit. This study calculated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves to evaluate screening and suicide outcome measures and costs for the two interventions relative to treatment as usual. Costs were calculated from the provider perspective (e.g., wage and salary data and rental costs for hospital space) per patient and per site. RESULTS: Average per-patient costs to a participating ED of universal screening plus intervention were $1,063 per month, approximately $500 more than universal screening added to treatment as usual. Universal screening plus intervention was more effective in preventing suicides compared with universal screening added to treatment as usual and treatment as usual alone. CONCLUSIONS: Although the choice of universal screening plus intervention depends on the value placed on the outcome by decision makers, results suggest that implementing such suicide prevention measures can lead to significant cost savings.

Re-engineering methadone-Cost-effectiveness analysis of a patient-centered approach to methadone treatment.

Methadone maintenance treatment has proven effectiveness in the treatment of opioid use disorder, but significant barriers remain to treatment retention. In a randomized clinical trial, 300 newly-admitted methadone patients were randomly assigned to patient-centered methadone (PCM) v. treatment-as-usual (TAU). In PCM, participants were treated under revised program rules which permitted voluntary attendance at counseling and other changes focused on reducing involuntary discharge, and different staff roles which shifted disciplinary responsibility from the participant's counselor to the supervisor. The study found no significant differences in treatment retention, measures of opioid use, or other patient outcomes. This paper employs an activity-based costing approach to estimate the cost and cost-effectiveness of the two study conditions. We found that service use and costs were similar between PCM and TAU. Specifically, the average cost for PCM patients was $2396 compared to $2292 for standard methadone, while the average length of stay was 2 weeks longer for PCM patients. Incremental cost-effectiveness ratios (ICER) for self-reported heroin use, opioid positive urine screens, and meeting DSM-IV criteria for opioid dependence were mixed, with TAU achieving non-significantly better outcomes at lower treatment episode costs (i.e., economically dominating) for opioid positive urine screens. PCM patients reported slightly more days abstinent from heroin and fewer meet the opioid dependence criteria. While these differences are small and not statistically significant, we can still examine the cost-effectiveness implications. For days, abstinent from heroin, the ICER was $242 for one additional day of abstinence, however, there was notable uncertainty around this estimate. For opioid dependence criteria, the ICER was $1160 for a one-percentage point increase in the probability that a participant no longer met criteria for opioid dependence at follow-up. This economic study finds that patient choice concepts can be introduced into methadone treatment without significant impacts on costs or patient outcomes.

Predictors of medical and mental health care use in patients with irritable bowel syndrome in the United States.

Because health care demand among IBS patients imposes a heavy economic burden, identifying high utilizers has potential for improving quality and efficiency of care. Previous research has not identified reliable predictors of utilization of IBS patients. We sought to identify factors predictive of health care utilization among severe IBS patients. 291 IBS patients completed testing whose content mapped onto the Andersen model of health care utilization. 2-stage hurdle models were used to determine predictors of health care use (probability and frequency). Separate analyses were conducted for mental health and medical services. Whether patients used any medical care was predicted by diet and insurance status. Tobacco use, education, and health insurance predicted the probability of using mental health care. The frequency of medical care was associated with alcohol use and physical health status, while frequency of mental health services was associated with marital status, tobacco use, education, distress, stress, and control beliefs over IBS symptoms. For IBS patients, the demand for health care involves a complex decision-making process influenced by many factors. Particularly strong determinants include predisposing characteristics (e.g., dietary pattern, tobacco use) and enabling factors (e.g., insurance coverage) that impede or facilitate demand. Which factors impact use depends on whether the focus is on the decision to use care or how much care is used. Decisions to use medical and mental health care are not simply influenced by symptom-specific factors but by a variety of lifestyle (e.g., dietary pattern, education, smoking) and economic (e.g., insurance coverage) factors.

The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings.

BACKGROUND: Among the nearly 750,000 inmates in U.S. jails, 12% report using opioids regularly, 8% report use in the month prior to their offense, and 4% report use at the time of their offense. Although ample evidence exists that medications effectively treat Opiate Use Disorder (OUD) in the community, strong evidence is lacking in jail settings. The general lack of medications for OUD in jail settings may place persons suffering from OUD at high risk for relapse to drug use and overdose following release from jail. METHODS: The three study sites in this collaborative are pooling data for secondary analyses from three open-label randomized effectiveness trials comparing: (1) the initiation of extended-release naltrexone [XR-NTX] in Sites 1 and 2 and interim methadone in Site 3 with enhanced treatment-as usual (ETAU); (2) the additional benefit of patient navigation plus medications at Sites 2 and 3 vs. medication alone vs. ETAU. Participants are adults with OUD incarcerated in jail and transitioning to the community. RESULTS: We describe the rationale, specific aims, and designs of three separate studies harmonized to enhance their scientific yield to investigate how to best prevent jail inmates from relapsing to opioid use and associated problems as they transition back to the community. CONCLUSIONS: Conducting drug abuse research during incarceration is challenging and study designs with data harmonization across different sites can increase the potential value of research to develop effective treatments for individuals in jail with OUD.

A randomized clinical trial of group versus standard behavioral couples therapy plus individually based treatment for patients with alcohol dependence.

OBJECTIVE: Multiple studies show that behavioral couples therapy (BCT) is more efficacious than individually based therapy (IBT) for substance use and relationship outcomes among patients with alcohol use disorder. To facilitate dissemination, a multicouple, rolling admission Group BCT (G-BCT) format has been suggested as an alternative to the 1 couple at a time, conjoint Standard BCT (S-BCT) format. This randomized study compared outcomes of G-BCT versus S-BCT over a 1-year follow-up. The authors predicted that G-BCT, as compared to S-BCT, would have equivalent (i.e., noninferior) improvements on substance and relationship outcomes. METHOD: Participants were patients (N = 101) with alcohol dependence and their heterosexual relationship partners without substance use disorder. Participants were mostly White, in their 40s, and 30% of patients were women. Patients were randomized to either G-BCT plus 12-step-oriented IBT or S-BCT plus IBT. Primary outcomes included Timeline Followback Interview percentage days abstinent and Inventory of Drug Use Consequences measure of substance-related problems. Secondary outcome was Dyadic Adjustment Scale. Outcome data were collected at baseline, posttreatment, and quarterly for 1-year follow-up. RESULTS: Results overall found no support for the predicted statistical equivalency of G-BCT and S-BCT. Rather than the predicted equivalent outcomes, substance and relationship outcomes were significantly worse for G-BCT than S-BCT in the last 6-9 months of the 12-month follow-up period, because G-BCT deteriorated and S-BCT maintained gains during follow-up. CONCLUSION: This was the first study of the newer rolling admission group format for BCT. It proved to have worse not equivalent outcomes compared to standard conjoint BCT. (PsycINFO Database Record

Behavioral Health Outcomes Among Adults: Associations With Individual and Community-Level Economic Conditions.

OBJECTIVE: This study examined the relationship between state and local economic conditions and serious psychological distress, substance use disorders, and mental health service utilization among adults in the United States. METHODS: Using data from 21,100 adults who responded to the 2008-2010 National Survey on Drug Use and Health, a nationally representative survey of the U.S. civilian noninstitutionalized population living in households, the study used multivariate methods to examine associations between selected macroeconomic conditions and behavioral health outcomes. RESULTS: Living in states in the top three quartiles for serious mortgage delinquency rate and in counties in the top three quartiles for unemployment rate was associated with a lower likelihood of using mental health services among individuals experiencing serious psychological distress (adjusted relative risk [ARR]=.54, .52, and .73, and ARR=.58, .62, and .71, respectively, versus quartile 1). Individual-level characteristics were the primary predictors associated with higher odds of having substance use disorders or experiencing serious psychological distress, but macroeconomic variables were not statistically significant predictors of these outcomes. CONCLUSIONS: Both individual-level socioeconomic characteristics and population-level macroeconomic conditions were associated with behavioral health outcomes. Prevalence of serious psychological distress and substance use disorders and use of mental health services varied by economic measure. The findings suggest that access to and availability of mental health services for individuals experiencing serious psychological distress may be more challenging for those who do not have health insurance or who reside in regions with higher rates of mortgage foreclosures or higher rates of unemployment.