Therapeutic Potential of Psychedelic Drugs: Navigating High Hopes, Strong Claims, Weak Evidence, and Big Money.

Therapeutic claims about many psychedelic drugs have not been evaluated in any studies of even modest rigor. The science of psychedelic drugs is strengthening however, making it easier to differentiate some promising findings amid the hype that suffuses this research area. Ketamine has risks of adverse side effects (e.g., addiction and cystitis), but multiple studies suggest it can benefit individuals with treatment-resistant depression. Other therapeutic signals from psychedelic drug research that merit rigorous replication studies include 3,4-Methylenedioxymethamphetamine (MDMA) for post-traumatic stress disorder (PTSD) and psilocybin for depression, end of life dysphoria, and alcohol use disorder. The precise mechanisms through which psychedelic drugs can produce benefit and harm are not fully understood. Rigorous research is the best path forward for evaluating the therapeutic potential and mechanisms of psychedelic drugs. Policies governing the clinical use of these drugs should be informed by evidence and prioritize the protection of public health over the profit motive.

Associations of hepatitis C virus (HCV) antibody positivity with opioid, stimulant, and polysubstance injection among people who inject drugs (PWID) in rural U.S. communities.

BACKGROUND: People who inject drugs (PWID) in the rural U.S. often inject stimulants, alone or with opioids. The impact of these substance use patterns may influence HCV risk behaviors. This analysis examines the associations of HCV antibody positivity with injecting only opioids, only stimulants (methamphetamine/cocaine), and opioids and stimulants together among rural PWID. METHODS: The Rural Opioid Initiative (ROI) consists of eight research sites that enrolled people who use drugs in rural communities in ten U.S. states from 2018 to 2020. This cross-sectional analysis included adult participants who resided in a study area and injected any drug in the past 30 days. The primary outcome was HCV antibody positivity. The exposure of interest was injection drug use classified as only opioids, only stimulants, separate injections of opioids and stimulants, and same-syringe injection of both in the past 30 days. We used multivariable log-binomial regression with generalized linear mixed models to generate prevalence ratios (P.R.) adjusted for demographics, injection history, health insurance, and substance use treatment. RESULTS: Among 3,084 participants enrolled in the ROI, 1,982 met inclusion criteria. Most participants injected opioids and stimulants in the same syringe (34%) or separately (21%), followed by injecting only stimulants (26%), and injecting only opioids (19%). Half (51%) were HCV antibody positive. Compared to people who injected only stimulants, HCV antibody positivity was more prevalent among people who injected opioids alone (aPR=1.62, 95% CI:(1.29-2.03)), injected both opioids and stimulants separately (aPR=1.61, 95% CI:(1.32-1.95)), and in the same syringe (aPR=1.54, 95% CI:(1.28-1.85)). CONCLUSION: HCV antibody positivity, indicating prior exposure, was highest among those who had recently injected opioids, alone or with stimulants. Additional nucleic acid testing is necessary to confirm active infection. More research is needed to determine the underlying causes of HCV antibody positivity by injection use.

Patient evaluation of a smartphone application for telehealth care of opioid use disorder.

BACKGROUND: People with opioid use disorder (OUD) face barriers to entering and remaining in life-saving treatment (e.g., stigma, detrimental interactions with health care, and privacy concerns). Telehealth and related technology can reduce barriers to entering and staying in care. Patient feedback is critical to the development of these newer treatment approaches to ensure they are usable and do not inadvertently recreate treatment barriers. PURPOSE: Evaluate the perceived usability of existing and planned features of a mobile application (app) that facilitates delivery of OUD treatment via telehealth. METHODS: People with current or prior experience with OUD treatment were eligible for the study. Participants (n = 31; 55% women) provided feedback on an interactive prototype demonstration via individual qualitative interviews and completed a quantitative survey on the app's perceived usability. Descriptive statistics summarized the usability survey. We analyzed qualitative interview transcripts to elicit common themes. RESULTS: Participants were primarily white (77%) with a mean age of 42.2 years (range 22-69). Participants rated the six major features of the current app as helpful (median response 5 out of 5) and appreciated the flexibility of conducting a visit from a place of their choosing. Participants regarded the five proposed components of the app, such as daily affirmations and medication treatment-related reminders (e.g., pick up medication at pharmacy, medication schedule), as useful features with medians 5 out of 5, and reported they would recommend the app to others for OUD care. Participant qualitative interviews provided additional information on perceived usability of existing and proposed app features. CONCLUSION: Our study suggests that an appealing, easy-to-use app-with tools and features that effectively support care-could circumvent existing barriers and foster sustained recovery.

Expanding access to medications for opioid use disorder through locally-initiated implementation.

BACKGROUND: Despite demonstrated efficacy, medication treatment for opioid use disorder (MOUD) remain inaccessible to many patients, with barriers identified at the individual, clinic and system level. A wide array of implementation strategies have guided efforts to expand access to MOUD, with most centered around externally-facilitated approaches to practice change. While effective, such approaches may be inaccessible to those clinics and systems that lack the resources necessary to partner with an external team, suggesting a need to identify and describe change-processes that are internally developed and promoted. METHODS: Guided by the Consolidated Framework for Implementation Research (CFIR), we utilized qualitative interviews and ethnographic observation to investigate the planning, design and implementation of a locally-initiated process to expand access to MOUD within one health care system. All study documents were coded by a primary coder and secondary reviewer using a codebook designed for use with the CFIR. To analyze data, we reviewed text tagged by key codes, compared these textual excerpts both across and within documents, and organized findings into themes. Processes identified were mapped to established implementation science constructs and strategies. RESULTS: Interviews with clinicians and administrators (n = 9) and ethnographic observation of planning meetings (n = 3) revealed how a self-appointed local team developed, established broad support for, and successfully implemented a Primary Care-based Buprenorphine Clinic and E-Consult Service to expand access to MOUD to patients across the health care system. First, national and local policy changes-including altered clinical practice guidelines, performance pay incentives regarding opioid prescribing, and a directive from VA Central Office increased individual staff and administrators' perception of the need for change and willingness to invest time and resources. Then, a self-appointed interdisciplinary team utilized cross-clinic meetings and information gathering to identify appropriate, and widely supported, models of care delivery and care consultation. Finally, the team increased staff investment in these change efforts by bringing them into the planning process and encouraging collaborative problem solving. CONCLUSIONS: This study reveals how a local team developed and built widespread support for new processes of care that were tailored to local needs and well-positioned for sustainability over time.

Hospital and outpatient health services utilization among HIV-infected adults in care 2000-2002.

BACKGROUND: Rapid changes in HIV epidemiology and antiretroviral therapy may have resulted in recent changes in patterns of healthcare utilization. OBJECTIVE: The objective of this study was to examine sociodemographic and clinical correlates of inpatient and outpatient HIV-related health service utilization in a multistate sample of patients with HIV. DESIGN: Demographic, clinical, and resource utilization data were collected from medical records for 2000, 2001, and 2002. SETTING: This study was conducted at 11 U.S. HIV primary and specialty care sites in different geographic regions. PATIENTS: In each year, HIV-positive patients with at least one CD4 count and any use of inpatient, outpatient, or emergency room services. Sample sizes were 13,392 in 2000, 15,211 in 2001, and 14,403 in 2002. MAIN OUTCOME MEASURES: Main outcome measures were number of hospital admissions, total days in hospital, and number of outpatient clinic/office visits per year. Inpatient and outpatient costs were estimated by applying unit costs to numbers of inpatient days and outpatient visits. RESULTS: Mean numbers of admissions per person per year decreased from 2000 (0.40) to 2002 (0.35), but this difference was not significant in multivariate analyses. Hospitalization rates were significantly higher among patients with greater immunosuppression, women, blacks, patients who acquired HIV through drug use, those 50 years of age and over, and those with Medicaid or Medicare. Mean annual outpatient visits decreased significantly between 2000 and 2002, from 6.06 to 5.66 visits per person per year. Whites, Hispanics, those 30 years of age and over, those on highly active antiretroviral therapy (HAART), and those with Medicaid or Medicare had significantly higher outpatient utilization. Inpatient costs per patient per month (PPPM) were estimated to be 514 dollars in 2000, 472 dollars in 2001, and 424 dollars in 2002; outpatient costs PPPM were estimated at 108 dollars in 2000, 100 dollars in 2001, and 101 dollars in 2002. CONCLUSION: Changes in utilization over this 3-year period, although statistically significant in some cases, were not substantial. Hospitalization rates remain relatively high among minority or disadvantaged groups, suggesting persistent disparities in care. Combined inpatient and outpatient costs for patients on HAART were not significantly lower than for patients not on HAART.