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FRI Selected with Chase Brexton Health Care as One of Five Sites for the CTN 0101 Trial

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 Receives Justice Community Opioid Innovation Network (JCOIN) Awards

Michael S. Gordon

Dr. Michael S. Gordon

Friends Research Institute was awarded one of 12 national grants from The National Institutes of Health and the National Institute on Drug Abuse as part of the Helping to End Addiction Long-term (HEAL) Justice Community Opioid Innovation Network (JCOIN). Drs. Michael Gordon and Shannon Gwin Mitchell are leading this important study. Individuals with opioid use disorder in seven Maryland county jails who consent to study participation will be randomly assigned to treatment with either extended-release naltrexone or extended-release buprenorphine.

Shannon Gwin Mitchell

Dr. Shannon Gwin Mitchell

The first injection will be provided prior to release followed by six monthly injections at a community treatment program. The study is significant because it will provide novel data on the comparative effectiveness of these two medications in reducing relapse to drug use, re-incarceration, and overdose death. The study will also provide insight into approaches to expand acceptance of long-acting medications for opioid use disorder treatment. Its findings will have far-reaching implications for treatment expansion in this high-risk population.

Robert P. Schwartz

Dr. Robert Schwartz

In addition, FRI was awarded a second of the 12 JCOIN grants through a collaboration of five research sites across the country, led by Dr. Josh Lee of the New York University School of Medicine. Dr. Robert Schwartz is leading the FRI effort as part of this study, which will compare the effectiveness of extended-release naltrexone and a different extended-release buprenorphine formulation than mentioned above among study participants in US jails and prisons. This study will provide novel data to assess two potentially useful re-entry treatment options for a population prone to relapse.

View NIH Press Release

Jan Gryczynski, Ph.D.

Dr. Jan Gryczynski Receives R01 Award

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.

Dr. Kimberly Kisler Receives First HRSA Award

FRI is pleased to announce that Dr. Kimberly Kisler, along with Co-Investigator Dr. Cathy J. Reback, have received a three-year grant from Health Resources and Services Administrations’ Special Projects of National Significance entitled, “Adaptation of an Evidence-informed Behavioral Health Intervention to Improve Health Outcomes among Black Men who have Sex with Men (BMSM) Living with HIV.” Black men who have sex with men (BMSM) living with HIV in Los Angeles County experience a number of interrelated and mutually reinforcing behavioral health challenges, including prejudice/discrimination, substance use, mental health disorder, housing instability, and other individual, cultural, and structural barriers that stand as obstacles to HIV care and other needed services. The funded intervention will target heavily impacted BMSM living with HIV, between the ages of 18 and 65 years, and who due to pervasive behavioral health issues are hard-to-reach, underserved, and underinsured. The primary goal of the adapted intervention will be to link or re-engage and retain BMSM living with HIV (N=90), who are heavily impacted by the intersectionality of other behavioral health issues, in HIV care so they can reach and sustain viral suppression. The intervention will be delivered across three months and includes a total of six case management sessions. The case management sessions will include detailed assessment of participants’ needs, barriers to treatment, and HIV risk behavior acuity, all leading to the development of a participant-centered treatment plan. Peer Case Managers will work with participants to increase HIV health literacy, identify and remove barriers to optimal HIV health care and other services, and to directly link participants to all needed services. Assessments will be conducted at baseline, 3-, 6-, and 9-months post-enrollment and will examine the following research questions: 1) What proportion of BMSM enrolled in the intervention will be retained in HIV care?; 2) What proportion of BMSM enrolled in the intervention will achieve undetectable viral load status and maintain it through 9-months post-enrollment?; and 3) How are individual- (e.g., mental health disorder, substance use) and/or structural-level (e.g., poverty, housing instability, racism/homophobia/HIV stigma) factors associated with HIV care outcomes among BMSM participants?

Dr. Cathy Reback Receives R01 Award

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.

Dr. Michael Gordon Receives R01 Award

FRI is pleased to announce that Dr. Michael Gordon, along with Co-Investigators Drs. Frank Vocci, Marc Fishman, and Faye Taxman have received a grant award from the National Institute on Drug Abuse entitled “Buprenorphine for probationers and parolees: Bridging the gap into treatment.” This five-year study is a two-group randomized controlled trial in which 320 men and women with Opioid Use Disorder (OUD) on community supervision in Baltimore will be randomly assigned to one of two treatment conditions: (1) Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment; or (2) Treatment as Usual (TAU): Participants will receive a referral to buprenorphine treatment in the community. Both conditions will receive information on overdose prevention. Participants will be assessed at baseline, and 1, 2, 3, 6, and 12 months post-intake using a comprehensive assessment battery. The Primary Aim: To compare the relative effectiveness of BBT to TAU in terms of: (a) illicit opioid urine test results. The Secondary Aim: To examine the extent to which BBT is superior to TAU in terms of: (b) number of days receiving opioid treatment; (c) number of days using illicit opioids; (d) quality of life (i. physical health; ii. mental health); (e) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); (f) criminal activity; (g) re-arrest; and (h) re-incarceration. The proposed study is significant because the large number of individuals under community supervision with OUD have limited access to an efficacious treatment, buprenorphine pharmacotherapy. The proposed study is innovative because it would be the first trial in the US assessing the effectiveness of interim buprenorphine initiated at a community supervision office compared to referral to a community treatment program. The public health impact would be widespread, as this model of care could be scaled-up throughout many areas of the US with criminal justice populations with high rates of OUD.

Michael S. Gordon

Interview: Dr. Michael Gordon on 5-year Study

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.

Shannon Gwin Mitchell

FRI Researcher Receives Conrad N. Hilton Foundation Award for Project Evaluation

FRI is pleased to announce that Dr. Shannon Gwin Mitchell will lead the evaluation of the National Council for Behavioral Health’s FaCES (Facilitating Change for Excellence in SBIRT) project. Funded by the Conrad N. Hilton Foundation, FaCES will assemble a team of national experts to develop a standardized implementation model – or a “change package” – for Screening, Brief Intervention and Referral to Treatment (SBIRT) for adolescent-serving primary care practices with a particular focus on Federally Qualified Health Centers. After developing the change package, the National Council will launch an SBIRT learning collaborative to test the effectiveness of the change package in primary care practices.

Jan Grycynski

FRI Researcher Receives New R01 Award

FRI is pleased to announce that Jan Gryczynski, along with Co-Investigators Drs. Robert SchwartzShannon Gwin Mitchell, and Christopher Welsh have received a grant award from the National Institute on Drug Abuse entitled “Navigation Services to Avoid Rehospitalization (NavSTAR) among substance users.” In recent years, the problem of repeat hospitalization has come under intense focus as a contributor to preventable morbidity and escalating healthcare costs. Substance use disorders (SUDs) are strongly associated with poor health outcomes and inefficient use of healthcare services, including repeat hospitalizations. Interventions that increase adherence to recommendations for outpatient medical care and SUD treatment could potentially help recently-hospitalized individuals to avoid unnecessary rehospitalization, associated morbidity, and medical expenses. This study is a randomized controlled trial comparing the effectiveness of Navigation Services to Avoid Rehospitalization (NavSTAR) vs. Treatment-as-Usual (TAU) for hospital patients with co-occurring medical problems and SUDs. Applying Andersen’s theoretical model of health service utilization, NavSTAR uses a small dedicated team to deliver the promising strategies of Patient Navigation and motivational interventions for hospital patients post-discharge, with the goal of facilitating engagement in outpatient medical and SUD treatment. Patient Navigators embedded within the substance abuse consultation liaison service at a large urban hospital will deliver patient-centered, proactive navigation and motivational services initiated during the hospital stay and continued for 3 months post-discharge. Participants randomized to TAU will receive usual care from the hospital and the substance abuse consultation liaison service. Participants will be assessed at study entry and again at 3-, 6-, and 12-months follow-up on various measures of healthcare utilization, substance use, and functioning. The primary outcome of interest is rehospitalization through 12 months. In addition, a range of secondary outcomes spanning domains of individual health, functioning, and service utilization will be assessed. The study will include an economic evaluation of NavSTAR from the service provider perspective. If NavSTAR proves to be effective and cost-effective in reducing rehospitalizations and improving outcomes in this high-risk patient group, it would have important implications for designing hospital discharge planning services, informing national cost containment initiatives, and improving public health.

Jan Grycynski

FRI Researcher Receives First R01 Award

FRI is pleased to announce that Jan Gryczynski, along with Co-Investigators Drs. Robert SchwartzShannon Gwin Mitchell, and Alexander Cowell have received a grant award from the National Institute on Drug Abuse entitled “A randomized trial of SBIRT services in school-based health centers.” Substance use among adolescents continues to be highly prevalent in the US. Likewise, many adolescents engage in sexual behaviors that place them at elevated risk for HIV and other sexually transmitted infections. Screening, brief intervention, and referral to treatment (SBIRT) is a promising approach for integrating substance use services into healthcare settings. School-based health centers (SBHCs) are a rapidly expanding model of healthcare delivery offering health services far beyond those of the traditional school health office. Implementing SBIRT in SBHCs could have major public health benefits, but research is needed to identify the most effective way to deliver SBIRT for adolescents in these settings. Two approaches for SBIRT that are particularly promising in their practicality, scalability, and sustainability are nurse practitioner-delivered brief intervention and computer-delivered brief intervention. We propose to conduct a randomized controlled trial to determine the comparative clinical effectiveness and cost-effectiveness of these two approaches in reducing marijuana use, alcohol use, and sex risk behaviors. The study will be conducted in SBHCs embedded within two public high schools in Baltimore, Maryland. SBHC patients ages 14-18, inclusive, will be screened for eligibility by research staff with the CRAFFT, a brief substance misuse screening instrument recommended by the American Academy of Pediatrics. The study will enroll 300 male and female adolescents who report risky marijuana or alcohol use. Participants will be randomly assigned to receive a nurse practitioner-delivered brief intervention (NBI) consisting of brief motivational advice as part of their medical visit, or a promising interactive computer-delivered brief intervention (CBI) based on motivational interviewing. Both intervention conditions will include HIV risk reduction content tailored based on individual risk factors, and both conditions will include a referral pathway for additional substance abuse assessment and possible treatment by specialized substance abuse treatment staff. Research assessments will be conducted at baseline and at 3- and 6-month follow-up, and will gather self-reported data on substance use and sexual risk behaviors. A focused economic analysis will compare the NBI and CBI conditions with respect to their incremental cost-effectiveness for selected primary behavioral outcomes and for quality-adjusted life years (QALYs). A qualitative process evaluation will examine adolescent participants’ and SBHC staff members’ perspectives on the competing BI strategies.