MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. Appeared originally in Nat Med 2021; 27:1025-1033.

Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial.

BACKGROUND: The extent of human interaction needed to achieve effective and cost-effective use of mobile health (mHealth) apps for individuals with mild to moderate alcohol use disorder (AUD) remains largely unexamined. This study seeks to understand how varying levels of human interaction affect the ways in which an mHealth intervention for the prevention and treatment of AUDs works or does not work, for whom, and under what circumstances. OBJECTIVE: The primary aim is to detect the effectiveness of an mHealth intervention by assessing differences in self-reported risky drinking patterns and quality of life between participants in three study groups (self-monitored, peer-supported, and clinically integrated). The cost-effectiveness of each approach will also be assessed. METHODS: This hybrid type 1 study is an unblinded patient-level randomized clinical trial testing the effects of using an evidence-based mHealth system on participants' drinking patterns and quality of life. There are two groups of participants for this study: individuals receiving the intervention and health care professionals practicing in the broader health care environment. The intervention is a smartphone app that encourages users to reduce their alcohol consumption within the context of integrative medicine using techniques to build healthy habits. The primary outcomes for quantitative analysis will be participant data on their risky drinking days and quality of life as well as app use from weekly and quarterly surveys. Cost measures include intervention and implementation costs. The cost per participant will be determined for each study arm, with intervention and implementation costs separated within each group. There will also be a qualitative assessment of health care professionals' engagement with the app as well as their thoughts on participant experience with the app. RESULTS: This protocol was approved by the Health Sciences Minimal Risk Institutional Review Board on November 18, 2019, with subsequent annual reviews. Recruitment began on March 6, 2020, but was suspended on March 13, 2020, due to the COVID-19 pandemic restrictions. Limited recruitment resumed on July 6, 2020. Trial status as of November 17, 2021, is as follows: 357 participants were enrolled in the study for a planned enrollment of 546 participants. CONCLUSIONS: The new knowledge gained from this study could have wide and lasting benefits related to the integration of mHealth systems for individuals with mild to moderate AUDs. The results of this study will guide policy makers and providers toward cost-effective ways to incorporate technology in health care and community settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04011644; https://clinicaltrials.gov/ct2/show/NCT04011644. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31109.

Effects of a nursing home telehealth program on spending and utilization for Medicare residents.

OBJECTIVE: To assess the effects of eLongTermCare (eLTC), a telehealth program implemented by an integrated health system in 45 nursing homes across the Midwest, on the use of acute hospital services and total expenditures for Medicare residents. DATA SOURCES: Minimum Data Set, Medicare fee-for-service claims, and enrollment data from 2013 to 2018. STUDY DESIGN: We used a longitudinal difference-in-differences design to estimate the changes in outcomes for treatment beneficiaries before and after participating in the eLTC program, relative to changes for the matched comparison beneficiaries over the same period. We measured outcomes over a 24-month follow-up period, including total Medicare spending, emergency department (ED) visits, hospitalizations, and the likelihood of readmission. DATA COLLECTION/EXTRACTION METHODS: Using administrative data, we identified treatment beneficiaries who stayed at participating nursing facilities during the program period and matched comparison beneficiaries with similar baseline characteristics from non-participating facilities in the same geographic locations. PRINCIPAL FINDINGS: For long-term care residents, the eLTC program led to an estimated reduction of 73 ED visits per 1000 beneficiaries (p < 0.01, 8.6% effect) over the two-year follow-up period. The estimated effects for this group were concentrated among beneficiaries who entered the nursing home after program startup, with sizable reductions in hospitalizations, ED visits, and spending. For skilled care residents, the program was associated with an estimated reduction of 85 ED visits per 1000 beneficiaries (p = 0.03, 9.7% effect), but had no discernible effect on their hospitalizations or total Medicare spending. CONCLUSIONS: Telehealth can be a valuable tool for nursing homes to enhance care coordination and provide timely access to care, leading to lower spending for nursing home residents. Future research needs to explore payment methods that encourage telehealth expansion in nursing homes.

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.

Six features of Medicare coordinated care demonstration programs that cut hospital admissions of high-risk patients.

As policy makers seek to slow the growth in Medicare spending, they have appropriately focused attention on beneficiaries with multiple chronic conditions. Many care coordination and disease management programs designed to improve beneficiaries' care and reduce their need for hospitalizations have been tested, but few have been successful. This study, however, found that four of eleven programs that were part of the Medicare Coordinated Care Demonstration reduced hospitalizations by 8-33 percent among enrollees who had a high risk of near-term hospitalization. The six approaches practiced by care coordinators in at least three of the four programs were as follows: supplementing telephone calls to patients with frequent in-person meetings; occasionally meeting in person with providers; acting as a communications hub for providers; delivering evidence-based education to patients; providing strong medication management; and providing timely and comprehensive transitional care after hospitalizations. When care management fees were included, the programs were essentially cost-neutral, but none of these programs generated net savings to Medicare. Our results suggest that incorporating these approaches into medical homes, accountable care organizations, and other policy initiatives could reduce hospitalizations and improve patients' lives. However, the approaches would save money only if care coordination fees were modest and organizations found cost-effective ways to deliver the interventions.