Dr. Frank Vocci

Dr. Frank Vocci Receives U01 Subaward

Drs. Nikej Shah of Nirsum Labs and Frank Vocci of Friends Research Institute are Co-Principal Investigators of an NIH UG3/UH3 grant, “Development of a novel drug to treat opioid use disorder.” All IND-enabling studies have been completed and the Food and Drug Administration (FDA) granted an IND to Nirsum to proceed to Phase I trials. NRS-033, a pro-drug opioid antagonist, is currently completing Phase I human trials. Nirsum Labs has been awarded a second NIH U01 award, “Select Late-Stage CMC, Nonclinical Studies, and Quality Programs to Accelerate NRS-033 Towards Pivotal Studies and Registration in Opioid Use Disorder” in which Dr. Vocci will be a Co-investigator. The purpose of the newly funded cooperative agreement is to expedite NRS-033 into Phase 3 trials and FDA registration. Accordingly, late-stage chemistry and manufacturing controls data will be developed for the Active Pharmaceutical Ingredient (NRS-033) and the drug product (a room temperature stable ready-to-use prefilled syringe). Other registration enabling non-clinical studies will be performed and Nirsum Labs will engage with the FDA to discuss Phase 3 protocols and other requirements for New Drug Application registration.

Dr. Hochstatter Receives an Administrative Supplement to Extend her NIDA-funded R01

FRI is pleased to announce that Drs. Karli R Hochstatter (PI) and Jan Gryczynski (Co-I), along with the Chief Medical Examiner from the New York City Medical Examiner’s Office, have received an administrative supplement entitled, “Addressing substance use among the social network of suspected drug overdose decedents: rapidly translating epidemiology into prevention intervention science.” This supplement will extend their NIDA-funded R01 study focused on identifying and tracking suspected overdoses in near real-time (parent award R01DA057685) into prevention intervention research by studying the timely delivery of services to a potentially hidden population with unmet needs: overdose decedents’ network members who use drugs. The Social Worker Outreach and Resource Delivery (SWORD) intervention is delivered by a trained social worker at the medical examiner’s office and integrates evidence-based strategies, including motivational interviewing, social support, and linkage to services, to mitigate health risks following loss to overdose. The specific aims of this supplement are to: 1) Estimate the prevalence of substance use and substance use disorders (SUDs) among the close social ties of overdose decedents, and 2) Examine the effect of the SWORD intervention on substance use, risk/protective behaviors, and service engagement among overdose decedents’ close social ties who use drugs. To achieve these aims, we will conduct a cross-sectional survey with 384 close social ties of overdose decedents to characterize substance use patterns by type of drug and estimate the prevalence of substance use and SUDs in this population. Up to 130 participants (65 SWORD, 65 Control) who report drug use will be invited to participate in an extended survey to examine outcomes of substance use, risk/protective behaviors, and service engagement. Data collected from these supplemental activities will provide critical information about how this time-sensitive service delivery opportunity prevents substance use risks among overdose decedents’ network members who use drugs.

Cathy Reback

Dr. Cathy Reback Receives R01 Award

FRI is pleased to announce that Dr. Cathy Reback, along with Dr. Sean Murphy from Weill Cornell Medical College (MPIs), have received a five-year R01 grant from the National Institute on Drug Abuse entitled, “Comparative- and Cost-effectiveness Research Determining the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression.” In addition to Drs. Reback and Murphy, the interdisciplinary investigative team of experts includes Drs. Tom Blue (FRI), Raphael J. Landovitz (UCLA), and Ali Jalali (Weill Cornell Medical College). This study builds on the promising findings from two HRSA-funded demonstration projects, The Alexis Project and Text Me, Girl!, which utilized Peer Health Navigation (PHN) and SMS (i.e., text messaging), respectively, for advancing trans women living with HIV to full viral suppression. Though the effectiveness of both interventions has been established, their comparative-effectiveness, required resources/costs, cost-effectiveness, and heterogeneous effects on subgroups, including those with a SUD, have not been evaluated. This Phase II comparative-effectiveness RCT will randomize participants (N=225) into: PHN alone (n=75), SMS alone (n=75), or PHN+SMS (n=75). Using the same time points as the HRSA projects, the repeated-measures design will assess participants at baseline, 3-, 6-, 12-, and 18-months post-randomization. The specific aims are to: 1) Conduct a comparative effectiveness research trial to determine the relative effectiveness of PHN vs. SMS vs. PHN+SMS in terms of: Primary (a) virologic suppression; and Secondary outcomes (b) HIV Treatment Adherence Self-Efficacy Scale scores; (c) the AIDS Health Belief Scale scores; (d) the Inventory of Socially Supportive Behaviors scores; and (e) urine drug screen results; 2) Identify the resources required to prepare for, implement, and sustain each intervention, and estimate the associated costs; 3) Conduct a comprehensive cost-effectiveness analysis to determine the relative value of each intervention from the healthcare-sector, state-policymaker, and societal perspectives; and, a Secondary Aim to determine heterogeneous intervention effects across interventions due to social and structural determinants of health and individual-level characteristics. Findings have the potential to improve individual and population health outcomes by generating significant improvements in viral suppression among trans women, and guiding service provision and public policy.

Friends Community Center Receives Grant

FRI’s community research site, Friends Community Center located in Hollywood, CA, was recently awarded the “Opioid Use and Stimulant Use Education and Outreach in 2S/LGBTQ+ Communities” grant funded by The Center at Sierra Health Foundation. Funding is awarded to organizations throughout California that are focused on expanding prevention and recovery services for people with substance use disorder.

In its second year of funding, The Spencer Project, will focus on implementing a holistic continuum of harm reduction and care services, specifically related to opioid and stimulant use, designed to benefit 2S/LGBTQ+ populations in the Hollywood/West Hollywood area of Los Angeles County. Using a two-pronged approach, The Spencer Project will combine harm reduction education through outreach to the community and a personalized treatment navigation plan for individuals identified as seeking treatment for opioid or stimulant use.

Friends Community Center Receives Grant

FRI’s community research site, Friends Community Center located in Hollywood, CA, was recently awarded the “Reducing Inequities in Priority Populations” grant funded through a partnership between Together Toward Health and Public Health Institute. Funding awarding aims to identify community-based organizations who provide services to populations disproportionately impacted by COVID-19 and Mpox. The project aims to serve hard-to-reach and historically underserved populations across Los Angeles County, specifically LGBTQ+ populations.

This project will focus on culturally appropriate outreach and engagement with LGBTQ+ individuals to increase good health outcomes surrounding COVID-19 and Mpox prevention and vaccination uptake. Direct service work with the communities will enable project staff to have two-way conversations to ensure personalized discussions, active listening, and wrap-around services to alleviate barriers to COVID-19 and Mpox vaccination.