CoMBAT Opioid Use Disorder: A Pilot RCT of a Combined Medication assisted and Behavioral Activation Treatment for People Living with Opioid Use Disorder

Research Project Leader
5/1/2019 – Present

Jaclyn White Hughto, PhD, MPH

Assistant Professor of Behavioral and Social Sciences; Assistant Professor of Epidemiology, Brown School of Public Health

Tel: 401-863-6580
Email: Jaclyn_Hughto@brown.edu

Biography

Jackie White Hughto, PhD, MPH is an Assistant Professor of Behavioral and Social Sciences and Epidemiology at the Brown School of Public Health. She is also faculty within the Center for Health Promotion and Health Equity at Brown University and an Adjunct Investigator at the Fenway Institute of Fenway Health in Boston, an interdisciplinary research center focused on understanding and improving health outcomes for sexual and gender minority populations and those at risk for or living with HIV. She received a PhD in Chronic Disease Epidemiology from the Yale School of Public Health, an MPH in Behavioral Sciences and Health Education from the Rollins School of Public Health at Emory University, and a BA in Psychology from Boston University.

Employing methods from the fields of epidemiology and behavioral science, Dr. Hughto examines the individual, interpersonal, and structural drivers of health inequities, with a focus on the impact of stigma on the health of sexual and gender minority populations, people who use drugs, and those living with HIV. Her research also includes the development and testing of bio-behavioral interventions to prevent and treat substance use disorder, overdose, HIV, and poor mental health in diverse populations domestically and internationally.

Dr. Hughto is currently the PI of two federally-funded grants including an NIGMS-funded award through the COBRE on Opioids and Overdose that involves the development and testing of a behavioral intervention to improve retention in care for individuals receiving medications for opioid use disorder; and a Center for Medicare and Medicaid (CMS) grant that explores engagement in the HIV prevention and care continuum for transgender and cisgender people using insurance claims data. She is also a Co-Investigator on five federally-funded grants, including a CDC-funded mixed-method study exploring the epidemiology of opioid-related overdoses in Massachusetts (NU17CE002724); an R34 that involves the development and testing of a PrEP uptake and adherence intervention for transgender women in Los Angeles (1R34MH122499-01A1); an R34 that involves the development and testing of an ART adherence intervention for sexual and gender minority youth in Brazil (1R34MH126894-01); a COBRE-funded pilot award that uses mixed methods to identify facilitators and barriers to substance use treatment for transgender people in Rhode Island (P20GM125507); and a pilot study funded by the NIAID-supported Providence/Boston Center for AIDS Research (CFAR) that uses mixed-methods to explores PrEP uptake and adherence among transgender youth across the US (P30AI042853).

Dr. Hughto has authored more than 80 publications. Her research has also been cited in expert testimony before state and federal courts to advance the health of gender minority and other underserved populations.

COBRE Abstract

CoMBAT OUD: Combined Medication and Behavioral Activation Treatment for people living with Opioid Use Disorder.

Background: Opioid use disorder is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medication for Opioid Use Disorder (MOUD) has been shown to reduce opioid use in diverse populations; however, long-term retention in MOUD care is often suboptimal. Depression, the stigma of opioid use and addiction, and limited self-efficacy to navigate life challenges have been shown to contribute to MOUD disengagement. Behavioral activation (BA) therapy is an evidenced-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder.

Conceptual Model. The conceptual model underlying BA posits that self-defeating behaviors, such as substance use and the behavioral avoidance of health-promoting resources serve the function of coping with negative feelings and make individuals feel better in the short-run, but ultimately exacerbate depression through a process of negative reinforcement. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression, cope with stigma, and build the capacity to navigate life challenges, pairing BA with MOUD could help to ensure continued engagement in care and improve treatment outcomes for individuals with opioid use disorder.

Overview of Study. Following the NIH Stage Model of psychosocial treatment development and testing, this study seeks to determine the feasibility of study procedures, enhance participant acceptability, and provide preliminary efficacy data to support the submission of a full-scale, NIH R01 efficacy trial. We will enroll individuals currently being treated with MOUD for opioid use disorder in a pilot randomized controlled trial (RCT) of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 8-session CoMBAT intervention; or 2) MOUD alone (treatment-as-usual). The primary outcome is retention in MOUD care. Secondary outcomes include days of opioid use, opioid positive urinalysis, and potential mediator (depression) and moderators (e.g., comorbid mental health conditions, substance use) of the intervention at baseline, and 3- and 6-months. Intervention feasibility and acceptability will also be assessed. This study will provide the requisite data to inform future efficacy testing of the intervention in a large-scale R01 trial, with the ultimate goal of developing an efficacious intervention to address the opioid epidemic.

Publications

Mentors

Funded Research

Ongoing Research Support

NIMH R34MH126894: Biello & Mimiaga (MPI) 05/01/2021-04/30/2024
Making Universal, Free-of-Charge Antiretroviral Therapy Work for Sexual and Gender Minority Youth in Brazil. The purpose of this study is to develop and pilot test a theory-driven, integrated group counseling and technology intervention, that aims to foster social support, self-efficacy and cognitive and behavioral skills to improve ART adherence among SGM youth (ages 15-24) living with HIV in Rio de Janeiro, Brazil. Role: Co-I.

NIMH 1R34MH122499-01A1: Mimiaga & Biello (MPI) 07/01/2020-06/30/2023
Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence among At-Risk Transgender Women (TGW). This study evaluates the preliminary efficacy of an intervention to address multilevel barriers to PrEP uptake and adherence among TGW. Role: Co-I.

NIGMS 1P20GM125507-01: Rich (PI)
Junior Investigator Award Hughto (PI) 05/01/2019-08/31/2021
CoMBAT Opioid Use Disorder: A Pilot RCT of a Combined Medication and Behavioral Activation Treatment for People Living with Opioid Use Disorder. This study evaluates the feasibility, acceptability, and preliminary efficacy of behavioral activation to facilitate retention in care and long-term reductions in opioid use among individuals with receiving medications for opioid use disorder. Role: PI.

CDC NU17CE002724: Ruiz (PI)
RACK Study: Green (PI) 11/15/2018-08/31/2023
Rapid Assessment of Consumer Knowledge on Opioids. Uses rapid assessment of consumer knowledge (RACK) methodology to examine the context underlying recent epidemiological trends in Massachusetts in the increase in opioid-related overdoses. Role: Co-I.

CMS Health Equity Research Award: Hughto (PI) 10/01/2018-03/14/2022
Characterizing Disparities in the HIV Prevention and Care Continuum among Transgender and Cisgender Medicaid and Medicare Beneficiaries. Uses Center for Medicare & Medicaid services claims data to explore disparities in HIV prevention and care engagement for transgender and cisgender adults. Role: PI.

NIGMS 1P20GM125507-01: Rich (PI)
Pilot Award: Operario (PI) 04/01/2021-03/31/2022
Substance Use Treatment for Transgender and Gender Diverse Adults. Uses mixed methods to examine the capacity of substance use treatment providers to care for transgender patients. Role: Co-I.

NIAID P30AI042853-20A1: Cu-Vin (PI)
Developmental Award: Gordon (PI) 04/01/2021-03/31/2022
Multi-level Determinants of Prep Awareness, Attitudes, and Experiences in A National Survey of Transgender And Gender Diverse US Young Adults. This mixed methods study aims to examine facilitators and barriers to accessing the PrEP continuum of care as well as preferences for PrEP education and delivery in a national sample of transgender young adults. Role: Co-I.

NIDA R01DA042805-01A1 Mimiaga & Safren (MPI) 04/01/2017-03/31/2022
Integrated Behavioral Activation and HIV Risk Reduction Counseling for MSM with Stimulant Abuse. This study tests the efficacy of an integrated psychosocial treatment (behavioral activation) and HIV risk reduction for HIV uninfected men who have sex with men with stimulant use disorder. Role: Cross-Site Coordinator.

Completed Research Support

PCORI AD–2017C1–6569: Reisner (PI) 04/01/2018-03/31/2021
Transgender Cohort Study of Gender Affirmation and HIV-Related Health. The study investigated the role of medical gender affirmation in HIV-care in a multisite clinical cohort of 5,100 transgender patients. Role: Co-I.

NIMHD 1R21MD012371-01 Jasuja & Rose (MPI) 09/20/2017-12/31/2020
Exploring Quality Measures for the Care of Transgender Persons. This study developed an algorithm to identify transgender people in commercial insurance data; characterize the healthcare received by transgender persons in the US; and begin the process of developing quality measures for transgender care. Role: Co-I.

NIAID P30AI042853-20A1: Cu-Vin (PI)
Developmental Award: Hughto (PI) 09/01/2018-08/31/2019
Examining Multilevel Factors Associated with Entry into and Engagement in the HIV Prevention and Care Continuum for Transgender Adults in Massachusetts and Rhode Island. Utilizes mixed methods to explore factors associated with engagement in HIV prevention and care services for transgender adults. Role: PI.

NIMHD F31MD011203-01: Hughto (PI) 09/01/2016-01/15/2018
Intervention to Overcome Mental Health Disparities in Criminally-Justice Involved Transgender Women. This documented the mental health effects of incarceration in transgender women and developed and evaluated a transgender cultural and clinical competency training for correctional healthcare providers. Role: PI.

CoMBAT Opioid Use Disorder: A Pilot RCT of a Combined Medication assisted and Behavioral Activation Treatment for People Living with Opioid Use Disorder

Jaclyn White Hughto, PhD, MPH

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