FRI is pleased to announce that Dr. Shannon Gwin Mitchell (PI) was recently awarded a new R01 grant from the National Institute on Drug Abuse. The “Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology” study will examine the use of a digital contingency management delivery tool for people with opioid and cocaine polysubstance use receiving methadone treatment. FRI Co-investigators include Drs. Maxine Stitzer, Jan Gryczynski, and Jesse Fletcher. Methadone is a highly effective treatment for opioid use disorder, but many patients leave treatment prematurely, placing them at high risk of relapse and overdose. Extensive research shows that comorbid cocaine use is associated with poor retention in methadone treatment. The newly-funded study will examine a novel intervention designed to improve methadone treatment retention and other outcomes among people with opioid and cocaine polysubstance use. The design is a 2-arm randomized controlled trial comparing participants receiving treatment as usual from the participating methadone treatment programs with those receiving the DynamiCare Health Contingency Management (DCM) app in addition to their methadone treatment. The primary behaviors relevant to retention that will be targeted with incentives using the DCM program include abstinence from opioids and cocaine, as verified via remote oral fluid testing, and medication pickup from the methadone program, as verified by clinic records. Findings from this project can improve the public health impact of methadone treatment by identifying an effective and scalable approach to address polysubstance use among patients at heightened risk of treatment dropout.
FRI is pleased to announce that Dr. Jan Gryczynski (PI) has been awarded an R01 grant from the National Institute on Drug Abuse. The “Take-Home Expansion: Scope and Impact Study”, or THESIS, will examine the impact of recent changes in the delivery of methadone treatment. FRI Co-investigators include Drs. Robert Schwartz, Mishka Terplan, and Karli Hochstatter. Key collaborators on the project include RTI International (Drs. Tami Mark and Gary Zarkin) and BayMark Health Services (Dr. Nicholas Van Dyke). Methadone is an effective treatment for opioid use disorder (OUD) that is delivered in the U.S. through specialized Opioid Treatment Programs (OTPs). Since the inception of the OTP system many decades ago, federal regulations have required frequent clinic attendance to monitor patients’ response to treatment and reduce the risks of methadone diversion. Patients could only ‘earn’ take-home methadone after significant time in treatment while demonstrating rigid standards for adherence and stability. The COVID-19 pandemic transformed service delivery practices at OTPs. To reduce crowding in clinics, SAMHSA regulators swiftly issued regulatory exemptions that gave most OTPs unprecedented discretion to provide take-home methadone doses and deliver counseling via telehealth. OTPs were suddenly permitted to dispense up to 14 days of take-home methadone for ‘less stable’ patients, and 28 days for ‘stable’ patients. In late 2021, SAMHSA reaffirmed the regulatory exemptions and announced intentions to pursue permanent regulatory reform for OTPs. The THESIS project will examine the scope and impact of these major changes to care delivery, both in the immediate aftermath of the regulatory exemptions and prospectively. The study will use clinical and administrative data from BayMark Health Services, the largest provider of outpatient OUD treatment in the U.S. It could provide critical data to guide regulators, OTP administrators, and practitioners, yielding novel data that could inform methadone treatment delivery over the next decade and beyond.
Dr. Karli Hochstatter of Friends Research Institute (FRI) has been awarded an R01 grant from the National Institute on Drug Abuse/National Institutes of Health HEAL Initiative, entitled “Identifying Suspected Drug Overdose Deaths in Near Real-Time Using Data Collected by Death Investigators.” Along with Dr. Hochstatter, the interdisciplinary team of experts include Co-Investigators Dr. Jan Gryczynski of FRI and Drs. Nabila El-Bassel and Smaranda Muresan from Columbia University. This study aims to improve monitoring of overdose fatalities and overcome barriers associated with significantly delayed death certificate data for suspected drug-related deaths. In close collaboration with the New York City (NYC) Office of Chief Medical Examiner (OCME), this study will comprehensively evaluate and refine a tool, named the Suspected Potential Overdose Tracker (SPOT), that uses data routinely collected during death investigations to identify accidental drug overdose as the cause and manner of death in near real-time. While preliminary findings show that SPOT is highly promising for identifying fatal overdoses in near real-time, there is a need to further enhance the tool, examine its performance across different subpopulations, and assess its performance and usability outside of NYC. Thus, this study aims to (1) Optimize SPOT through additional data from the NYC OCME to improve performance of the tool and develop advanced features using natural language processing; (2) Assess barriers and facilitators of adopting SPOT in preparation for its deployment through semi structured interviews with users of overdose mortality data; and (3) Evaluate the usability and performance of SPOT in coroner/medical examiner offices across New York State, including counties involved in the NIDA-funded HEALing Communities Study. The public health implications of adopting this tool are significant, as near real-time data on overdose deaths will allow for rapid data-driven decision making, the identification of gaps in public health and public safety overdose response preparedness, and opportunities to evaluate overdose prevention interventions, programs, and policies. If found successful, the SPOT methodology can be readily disseminated to other states to enhance surveillance of drug overdose mortality.
FRI is pleased to announce that Drs. Michael S Gordon (MPI) and Thomas R. Blue (Co-I), along with Dr. Curt Beckwith (MPI) from The Miriam Hospital/Rhode Island Hospital and Alpert Medical School of Brown University and Dr. Lauren Brinkley-Rubinstein (MPI), from the Social Medicine at UNC—Chapel Hill have received a three-year R34 grant from the National Institute on Drug Abuse entitled, Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community. The study will be conducted in in collaboration with the Maryland Department of Public Safety and Correctional Services (MD DPSCS) and Total Health Care.
The study has three specific aims. Aim 1: Conduct interviews with justice and treatment experienced persons living with HIV (PWH) (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition PWH with viral suppression on oral anti-retroviral therapy (ART) to long-acting injectable ART in prison with continuation during community re-entry. Aim 2: Develop an initial LAI ART community re-entry protocol based on Aim 1 findings and conduct an open label pilot study. Post-release follow up will occur for three months among 10 incarcerated PWH eligible for LAI ART who are near release from prison in order to optimize protocol procedures including participant recruitment, initiation of LAI ART in prison, transition of LAI ART to community providers, and to evaluate study retention methods and assessments, including post-release HIV viral loads and urine drug testing, during the follow-up period. Aim 3: Following optimization of the LAI ART community re-entry protocol, conduct a pilot RCT among 50 incarcerated PWH eligible for LAI ART and scheduled to be released from prison; participants will be randomized 1:1 to transition cabotegravir (CAB), the first FDA-approved LAI ART regimen, or continue their daily oral ART regimen through a six-month follow-up period after release. During the follow-up period, we will assess the primary outcome of HIV viral suppression and secondary outcomes including ART adherence, substance use, and continuance of the assigned LAI or oral ART regimen.
FRI is pleased to announce that Drs. Michael Gordon, Thomas Blue, Frank Vocci and Shannon Mitchell along with Dr. Marc Fishman from Mountain Manor Treatment Center and Dr. Sean Murphy from Weill Cornell Medicine received a two-year administrative supplement to their HEAL- JCOIN grant entitled, “A comparison of sublingual and extended-release buprenorphine for individuals leaving jail.” This study consists of adding a quasi-control arm to the parent study wherein 120 incarcerated men and women receiving Sublingual buprenorphine (SL-B) in jail will be asked to participate by continuing their buprenorphine in the community and completing follow-up assessments over 12 months post-release (Monthly follow-ups during months 1-7 and a final follow-up at month 12). This quasi-control arm will be compared to participants randomized to extended-release buprenorphine (XR-B) in the parent study. Because participants will not undergo random assignment, data will be balanced to avoid biases from unequally distributed pretreatment covariates by way of propensity score weighting. HEAL JCOIN common measures will be utilized to facilitate data harmonization and cross-study analyses. We plan to conduct semi-structured interviews with correctional administrators, correctional officers; and jail health providers (N=25) to understand issues related to implementation of SL-B in jails.
The study has three specific aims: Aim 1. To determine the effectiveness of XR-B compared to SL-B in terms of (a) pharmacotherapy adherence (days in buprenorphine treatment), b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. Explore barriers and facilitators to SL-B implementation in jail: (1) dose induction; (2) diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another facility; (4) staffing (both custody and medical) needs for daily buprenorphine dosing; and (5) the process of verifying the dosage of an individual coming from a community maintenance program after being arrested. Aim 3. To (a) calculate the cost to the correctional health system of implementing and sustaining an SL-B or XR-B program (XR-B costs are being calculated in parent trial but will need to be estimated for new sites); and (b) determine the relative value of XR-B compared to SL-B, including the subsequent community treatment costs, from a state-policymaker and societal perspective.
Dr. Nikej Shah of Nirsum Labs and Dr. Frank Vocci of Friends Research Institute have been awarded the final three years of a UG/UH3 grant titled: Development of a Novel Drug for Treating Opioid Use Disorder from the National Institute on Drug Abuse/National Institutes of Health HEAL Initiative. The project will now shift from IND-enabling work to a Phase I Clinical Pharmacology study of NRS-033, an opioid antagonist investigational product, in healthy human male and female volunteers. The objectives of the study will be to assess the safety and tolerability of NRS-033 and its pharmacokinetics in plasma following a single intramuscular injection.
Dr. Jesse Fletcher was recently awarded (Co-I: Dr. Jae Sevelius) an NIMH-funded grant entitled “Development and Testing of an Identity Measure for Transgender and Gender Diverse Persons” to create a multidimensional measure of gender identity specific to transfeminine persons, establish the reliability and validity of this new measure, and estimate associations between instances of identity non-verification and participants’ HIV-related (and other critical) health outcomes. This study will be the first formal application of identity theory to transfeminine persons, allowing for the creation of all the relevant identity theory metrics (e.g., multidimensional identity standards, multisource reflected appraisals, salience/prominence/commitment ratings) and mechanisms (e.g., identity non-verification as the difference between identity standards and reflected appraisals) which comprise the framework and set it apart from its compatriots (e.g., gender affirmation theory; minority stress and resilience). Evidence demonstrates that transfeminine persons (i.e., those persons assigned male sex at birth but who identify as more feminine along the gender identity spectrum) are at dramatically elevated risk for HIV and a number of other detrimental health outcomes in part as a result of pervasive exposure to gender-based stigma and discrimination. Such prejudicial treatment is internalized by transfeminine persons as “identity non-verification,” a well-established behavioral mechanism in Identity Theory which has yet to be broadly adopted by researchers studying transfeminine populations. The study would occur in two stages, beginning with a Development Stage in which in-depth interviews are carried out with a purposively sampled group of transfeminine persons evenly split by age and HIV status. This is followed by the Testing Stage (N = 150), in which the reliability and validity of the new measure could be established, and a test of how identity non-verification is associated with critical health outcomes will be carried out. A deeper and more granular understanding of how transfeminine persons see themselves, how they believe other people see them, and how differences between these two constructs are associated with HIV-related outcomes and risks (including exposure to HIV and uptake/adherence to ART or PEP/PrEP) could generate new hypotheses, better research questions, and new methods of intervening in one of the populations most affected by HIV in the US.
Multiple Principal Investigators, Dr. Mary Mitchell from Friends Research Institute and Dr. Alicia Lucksted from the University of Maryland, were awarded a 3-year R34 grant entitled, “Intervention to Reduce Internalized Stigma (IRIS) among People Living with HIV who use Substances.” The purpose of the grant is to adapt and test an existing intervention to reduce self-stigma among people living with HIV (PLWH) with opioid use disorder and/or cocaine use disorder. The first year of the grant includes formative interviews with PLWH and key informants, and two pilot rounds of delivering the group intervention via Zoom. The grant culminates in a 2-year randomized clinical trial with 70 PLWH to test the intervention feasibility and acceptability, and preliminary measures of effectiveness.
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, “Optimizing PrEP Implementation and Cost-effectiveness among Sexual and Gender Minority Individuals with a Substance Use Disorder.” In addition to Drs. Reback and Murphy, the interdisciplinary investigative team of experts includes Drs. Steve Shoptaw and Raphael J. Landovitz (UCLA), David Benkeser (Emory University), and Ali Jalali (Weill Cornell Medical College). This study builds upon the highly promising findings from our open-label Phase I A.S.K.-PrEP (Assistance Services Knowledge-PrEP) pilot, which utilized PrEP navigation with text message (SMS) support to increase PrEP initiation among transgender women (TW) and men who have sex with men (MSM). This Phase II study will implement a RCT with a Stepped Care design of ASK-PREP vs. standard of care (SOC) to determine optimal intervention response among TW/MSM with a Substance Use Disorder (SUD; N=285; n=95 TW; n=190 MSM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n=214) or SOC (n=71). Participants in the Stepped Care arm receive the same ASK-PrEP intervention that was delivered in the pilot study and will be assessed at 3-months for intervention response; responders will be maintained in ASK-PrEP, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone). The specific aims are to: 1) Evaluate a Stepped Care approach promoting advancement along the PrEP Care Continuum and reductions in substance use among TW/MSM with a SUD; 2) Estimate the cost of implementing and sustaining each intervention and conduct a cost-effectiveness analysis to determine the value of each intervention relative to SOC, and to each other, from the healthcare-sector, state-policymaker, and societal perspectives; Secondary Aim 1) Determine the individual effects of specific substances, routes of administration, severity of SUD, social and structural determinants of health, and differing individual-level characteristics as moderators of outcomes; and Exploratory Aim) Evaluate intervention engagement and response by chosen PrEP modality (oral daily or long-acting injectable). The “intent-to-treat” RCT uses repeated assessments at baseline and at 3-, 6-, 9-, and 12-months post enrollment. Although PrEP is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes, and the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration. Thus, this Phase II RCT could have significant public health impact by identifying scalable and effective PrEP interventions that match intensity and participant needs to maximize efficacy while minimizing costs.
FRI’s community site, Friends Community Center, was recently awarded the “Opioid Use and Stimulant Use Prevention and Recovery Services in the LGBTQ2S+ Community” grant funded by The Center at Sierra Health Foundation. Funding awarded through to The Center’s Medication Assisted Treatment (MAT) Access Points Project is allotted to organizations throughout California focused on expanding prevention and recovery services for people with substance use disorder (SUD).
Our new project, The Spencer Project, will focus on implementing a holistic continuum of harm reduction and care services, specifically related to opioid and stimulant use prevention, designed to benefit men who have sex with men and transgender individuals in the Hollywood/West Hollywood area of Los Angeles County. Additionally, The Spencer Project will promote sustainability through the creation of a community advisory board to obtain insight regarding the formation of a network of culturally responsive, trauma-informed, and stigma free providers.