Dr. Misha Terplan, FRI Medical Director, in collaboration with Dr. Sarah Roberts (UCSF) were recently awarded a grant from the Foundation for Opioid Response Efforts (FORE) to address stigma through professional education and training. Entitled “Doing Right at Birth: Reducing stigma and improving recovery through professional education around child welfare reporting,” the project goal is to make interactions between birthing people with opioid use disorder (OUD) and both healthcare providers and the child welfare system (CWS) more ethically sound, respectful, grounded in evidence, and within but not exceeding legal requirements, and thereby reduce stigma and discrimination and improve treatment engagement and recovery postpartum and beyond. The project will be convening experts in health, policy, law, and advocacy, including people affected by the CWS, to: 1) develop and disseminate trainings (webinars, a self-paced video course, toolkit) on CWS reporting and consequences for birthing people with OUD, and 2) create a cadre of provider champions to bring about reporting policy changes.

Friends Research Institute (FRI) and its clinical collaborators at Chase Brexton Health Care are serving as one of the five sites in a National Institute of Drug Abuse (NIDA) Clinical Trials Network study, entitled the Subthreshold Opioid Use Disorder Prevention (STOP) trial. Research personnel at FRI will assist with the conduct of the study.

The study tests a collaborative care intervention that aims to reduce risky opioid use in adult primary care patients who do not have moderate-severe opioid use disorder. Risky opioid use is defined as nonmedical use of prescribed opioids (taking a higher dose or taking an opioid more frequently than prescribed), any use of illicit opioids, or taking pharmaceutical opioids that were not prescribed to the individual taking them. In this cluster randomized trial, enrolled patients of participating primary care providers will be randomly assigned to the STOP intervention vs. enhanced usual care condition, and followed for 12 months. In the intervention, patient participants will receive support from a nurse care manager and a telephone health coach, as well as brief advice from their primary care provider. Findings from the study will shed light on the efficacy of a collaborative care model to reduce days of risky opioid use, and potentially to prevent opioid use disorder and other opioid-related health problems, in primary care.

FRI is pleased to announce that Dr. Jan Gryczynski, along with Co-Investigators Drs. Robert Schwartz, Shannon Mitchell, and Kathleen Page have received a grant award from the National Institute on Drug Abuse, entitled Opioid Use Disorder Treatment Linkage at STD Clinics using Buprenorphine (OUTLAST-B). Untreated opioid use disorder (OUD) is a continuing public health emergency in the United States, and is associated with significant morbidity and mortality, including overdose death. Buprenorphine is an effective treatment for OUD, but most individuals who need such treatment do not access it. Public STD clinics are high-volume, episodic care medical settings that serve a high-risk population, often on a walk-in basis. The OUTLAST-B study will examine OUD treatment linkage strategies for opioid-dependent patients seeking services at public STD clinics. This three-arm, parallel randomized clinical trial (RCT) will compare Usual Care (UC), vs. referral via Patient Navigation (PN), vs. Patient Navigation with STD-clinic initiated buprenorphine (PN+BUP). The UC Arm will include standard services at the STD clinic. The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment. The PN+BUP Arm will include all UC and PN Arm services, with the addition of meeting with the STD clinic’s buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. Research assessments consisting of a structured interview battery and biomarkers for drug use and STDs will be conducted at baseline, 3-, and 6-month follow-up, while selected outcomes will be examined through 12-months via health record linkage. The study will examine participant outcomes in the domains of: (1) OUD treatment entry and retention, (2) Opioid use and related problems (including fatal and non-fatal overdose), and (3) HIV/STD-related outcomes. This study could identify new approaches to engaging a high-risk patient population in OUD treatment. Findings from the study could inform novel integration across two traditionally separate service sectors of STD care and OUD treatment.

FRI is pleased to announce that Dr. Cathy Reback, along with Co-Investigators Drs. Jesse Fletcher, also from FRI, and Adam Carrico from University of Miami, have received a grant from the National Institute on Drug Abuse entitled, “Getting Off: A Theory-based mHealth Intervention for Methamphetamine-using Men who Have Sex with Men (MSM).” The Phase II study builds upon the established efficacy of Drs. Reback’s and Steve Shoptaw’s group-based manualized methamphetamine abuse treatment intervention, “Getting Off: A Behavioral Treatment Intervention for Gay and Bisexual Male Methamphetamine Users,” and the highly promising findings from the successful Stage I proof-of-concept study conducted by Drs. Reback, Carswell, Gryczynski, and Fletcher. This five-year study will complete translation of the Getting Off group-based manual into a cross-platform (iOS and Android) mobile app and assess the app’s efficacy and non-inferiority in a randomized controlled trial (RCT). The Getting Off app, like the group-based intervention before it, will use the principles of Cognitive Behavioral Theory and Stages of Change to help MSM reduce or eliminate methamphetamine use and HIV sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum (including uptake of HIV testing, pre-, and post-exposure prophylaxis [PEP/PrEP] and PrEP adherence and persistence for those who are HIV negative; ART uptake and adherence for those who are HIV positive). Following the development of the group-based Getting Off intervention into a cross-platform computerized mobile app, including formative work and a feasibility pilot test, the study will conduct a RCT trial to evaluate reductions of methamphetamine use and HIV sexual risk behaviors, and increased advancement along the HIV Prevention or Care Continuum, using three approaches: a) Efficacy Trial – a two-arm RCT to determine intervention effects through comparison of the Immediate Delivery (ID; n=150) and Delayed Delivery (DD; n=150) arms; b) Efficacy Trial – an observed treatment effects analysis to compare pre/post data from the pooled ID and DD conditions (N=300); and, c) Non-inferiority Trial – a two-arm historical matched comparison design to evaluate the outcomes of the Getting Off app (ID + DD; N=300) relative to a matched sample of participants having previously attended the brick-and-mortar, group-based Getting Off intervention (N~600; total N=900). The RCT uses repeated measures to assess participants at baseline, 1-, 2- (DD condition only), 3-, 6-, and 9-month follow-up. This study could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent and highly scalable methamphetamine treatment to this very high-risk population.

FRI is pleased to announce that Dr. Michael Gordon was recently interviewed by a reporter from WBAL-TV in Baltimore to discuss his 5-year National Institute on Drug Abuse (NIDA) funded study entitled “Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment,” which uses Vivitrol in an effort to help pre-release inmates reduce opiate-taking behavior as they transition back to the community.

View the interview.