Clinical Research Directory

Employing Peer Outreach and Whole Health in Recovery for Homeless-Experienced Veterans

Homelessness is a national crisis in the United States, particularly in the veteran population. Due to multiple chronic conditions, homeless individuals frequently become hospitalized or are treated in emergency departments. Care engagement can mitigate this risk. Interventions grounded in evidence-based practices of peer support and whole health are effective for increasing care engagement. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, whole health intervention for homeless-experienced veterans in permanent supportive housing.

Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy

The aim of the present study is to examine the effects of keeping a therapy journal (journaling) on the effectiveness of cognitive behavioral therapy (CBT). Homework assignments are a fundamental component of behavioral therapies. In line with the learning theory foundation of behavioral therapies, various types of homework are used to facilitate learning processes between therapy sessions and to enable patients to make progress. One way to enhance individual goal setting and reflection in patients is through the use of "therapy journals." The goal of the planned project is to evaluate the effectiveness of goal-oriented journal writing as an additional element in cognitive behavioral therapy (CBT). To do this, psychotherapy patients will be randomly assigned to two treatment groups: CBT vs. CBT + Journaling. Patients will be block-randomized until 40 patients have completed the study in each treatment arm (at least 10 completed sessions).

Screening, Evaluation and Assessment (SEA) Protocol at the NIDA IRP

Background: People who will participate in research studies need to undergo proper screening, evaluation, and assessment (SEA). SEA helps keep those who participate in studies safe. It also helps ensure accurate study results. The National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) wants to screen people with alcohol and/or substance use disorders (ASUD) as well as people without ASUD for ongoing studies at NIDA in Baltimore, MD Objective: To screen people with or without ASUD for ongoing studies at NIDA. The ultimate goals are to learn why some people (1) use drugs; (2) stop using drugs; (3) use drugs but do not get addicted; and (4) never use drugs snd to develop ASUD treatments. Eligibility: People aged 18 years and older. They may (1) currently use nicotine, alcohol, opioids, cocaine, or other drugs; (2) no longer use them; or (3) have never used them. Design: Participants will have 1 screening visit that could last up to 8 hours. The visit may be split over more than 1 day. The duration of the screening may vary for each individual based on which studies they are interested in and screened for. The tests they undergo may vary and may include the following: * Physical exam. * Blood, saliva, and urine tests. * Breath samples that test for alcohol and carbon monoxide. * Test of heart function. * Smell test that measures sense of smell. * Tests of memory, attention, and thinking. * Mental health evaluation. * Mock magnetic resonance imaging (MRI) scan. * Questionnaires about alcohol and other drug use, mental health, medical history, and life in general.

Defining Neurobiological Links Between Substance Use and Mental Illness

Background: Nicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (MDD) are twice as likely to use nicotine compared to the general population. They have greater withdrawal symptoms and are more likely to relapse after quitting compared with smokers without MDD. More research is needed on how nicotine affects brain function in those with MDD. Objective: To understand how nicotine affects symptoms of depression and related brain function. Eligibility: People aged 18 to 60 years, at the time of consent, with and without MDD who do not smoke cigarettes or use other nicotine products. Design: Participants will have 2 or 3 study visits over 1 year. Participants will have 2 MRI scans no less than 4 days apart. Each scan visit will last 5 to 7 hours. At each scan, they will have urine and breath tests to screen for recent use of alcohol, nicotine, and illegal drugs. Before each scan, they will take 1 of 2 medications: nicotine or placebo. Participants will receive each medication once. They will not know which medication they are receiving at each scan. For each MRI scan, they will lie on a table that slides into a cylinder. Sometimes they will be asked to lie still. Sometimes they will complete tasks on a computer. Tasks may include identifying colors or playing games to win money. Each scan will take about 2 hours. Participants will answer questions about their thoughts, feelings, and behaviors before and after each scan. They will have a blood test after each scan.

Psychosocial Factors in Dual Diagnosis in a General Hospital

Dual diagnosis, defined as the co-occurrence of a mental disorder and a substance use disorder, is frequently associated with increased clinical severity, functional impairment, and poorer health outcomes. Identifying psychosocial protective factors related to better clinical and functional outcomes is essential to improve patient care and treatment planning. The aim of this observational, cross-sectional, single-center study is to analyze psychosocial protective factors and their association with clinical-functional outcomes in hospitalized patients with dual diagnosis. The study will be conducted in a general hospital setting and will include adult inpatients diagnosed with dual diagnosis according to clinical criteria. Sociodemographic, clinical, and psychosocial variables will be collected using standardized assessment tools and clinical records. The results of this study are expected to contribute to a better understanding of psychosocial factors associated with clinical severity and functional outcomes in patients with dual diagnosis, supporting more comprehensive and patient-centered care approaches.

Testing the CrOss Systems Technical Assistance for Retaining Staff (COSTARS) Model for Improving Staff Retention Among Child Welfare Workers and Peer Supporters, and Implementation of Evidence Based Interventions.

The goal of this study is to test whether the CrOss System Technical Assistance for Retaining Staff (COSTARS) supervision leadership institute can promote workforce stability and improved implementation outcomes within the Ohio START child welfare program. The main questions it aims to answer are: * Among supervisors, caseworkers, and family peer mentors, what is the effect of COSTARS on staff retention and perceptions of the work environment? * What is the effect of COSTARS on service timeliness, implementation fidelity, and parent outcomes within Ohio START? Researchers will compare public children services agencies implementing COSTARS to those implementing supervision practices as usual to see if there are differences between groups in the outcomes described above. Participating supervisors will: * Complete a 6-hour training workshop in the FOCUS model of supervision. * Participate in monthly group coaching sessions with other supervisors, for approximately one year. * Receive individualized feedback from coaches about their supervision performance.

Personalized Approach to Healthy Use and Recovery (PATH) Trial

An important part of substance use treatment for many people is learning what triggers their substance use and urges, and how they can better manage those triggers. In this study, the investigators will generate a model for each individual that shows likely causal links between their substance use, urges, and comorbid symptoms (e.g., anxiety, depression, and PTSD), and the investigators will examine these models as a group to draw conclusions about common causes for substance use (and recovery) among Veterans with substance use disorders. The investigators will also test whether receiving a personal model and clinical feedback improves substance use disorder and comorbid symptom outcomes. Results will include both patient-reported and statistically-determined causes of substance use for individuals and groups, clinical impact of a personalized model and feedback session, and participant feedback about the relevance of this study and intervention.

A Type I Hybrid Effectiveness-Implementation Trial of MIO

Mothers with substance use disorders face unprecedented stress in their roles as parents working to care for their children while maintaining healthy recovery. Mothering from the Inside Out (MIO) is the first attachment-based parenting intervention designed specifically for mothers in recovery from substance use disorders that has been shown to have benefit for both mother and child in multiple randomized controlled trials. This project will: (a) test the effectiveness of MIO among women in outpatient treatment under 'real-world' conditions, (b) evaluate implementation in different settings, and (c) assess key implementation factors to support optimal uptake and treatment in future dissemination studies; closing an important science-to-service gap for an underserved population in an effort to support maternal and child health simultaneously.

A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder

Digital interventions have the potential to support healthier behaviors among pregnant and postpartum women (PPW) with substance use disorders (SUDs) and may also provide a promising method for reducing their self-stigma. Enhearten is a digital intervention designed to foster adherence to medications for addiction treatment (MAT) while considering the unique needs of PPW, but its effects on self-stigma, treatment retention, and SUD outcomes have not been rigorously tested. The investigators will conduct an individual-level multicenter randomized controlled trial to test the feasibility, acceptability, and efficacy of Enhearten on reducing self-stigma and on improving SUD treatment and recovery outcomes with a stigma-focused ecological momentary intervention (EMI) designed to: 1) screen for feelings of stigma and 2) counteract these vulnerabilities among PPW with SUD via just-in-time interventions.

OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit

Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, higher suicidal ideation, and higher substance use and relapse rates. Treating OSA with evidence-based positive airway pressure (PAP) in Veterans with SUD/PTSD on a residential unit is a logical way to maximize treatment adherence and treatment outcomes. This study compares OSA treatment while on a SUD/PTSD residential unit to a waitlist control group. The investigators hypothesize that treating OSA on the residential unit, compared to the waitlist control, will have better functional, SUD, and PTSD outcomes.

Neuromodulation in Substance Use Disorders

The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs.

Smoking Cessation CM for Veterans With or at Risk for Cancer

Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing. In the first year, the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. In the second year, they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period. The success of the pilot study will determine whether to proceed with a larger randomized controlled trial (RCT) in years three to six, comparing the efficacy of mobile CM with standard treatment. The project will take place at SFVA.

Successful Transitions and Reintegration Tools for Veterans (START-VETS)

This study will develop prison reentry materials for Veterans leaving prison.

Targeting Drug Memories With Methylphenidate

This study aims to identify the neural, behavioral, and pharmacological mechanisms promoting diminished expression of drug-related memories in human drug addiction. In this fMRI study with a within-subjects placebo-controlled double-blind cross-over design, oral methylphenidate (20 mg) or placebo will be administered to individuals with cocaine use disorders (CUD) to peak during the retrieval of a drug-cue memory before extinction; in addition to fMRI activations, skin conductance responses (SCR, acquired simultaneously) will serve as the psychophysiological indicators of memory modification. Assessments of interference with the return of drug-cue memories via SCR and craving will be conducted the day following MRI. This pharmocologically-enhanced behavioral approach to decreasing drug memories and craving in iCUD could ultimately be used to develop effective cue-exposure therapies for drug addiction. Procedures include MRI, blood draw, questionnaires and interviews, skin conductance response measures, and behavioral tasks.

Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care

This project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents. The investigators believe that pediatric primary care providers (PCP) could play an important role in helping youth with SUD because most adolescents see their PCPs for annual wellness visits. However, PCPs have many barriers to treating their young patients with SUD/OUD: lack of training, resources, and support to deliver SUD/OUD services, limited time with patients, and the only available referral options often come with long wait times for an appointment. Through this project, the investigators will build upon an existing Integrated Behavioral Health (IBH) system by offering stigma-reduction interventions and brief SUD interventions within primary care settings. The goal of this project is to learn if clinics participating in an Integrated Behavioral Healthcare Program with SUD resources will increase delivery of effective adolescent SUD care and ultimately lead to better health outcomes when compared to standard primary care treatment. During the first project phase, the research team will gather a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the primary care-based SUD interventions. The investigators will gather input from national experts, local stakeholders, and PCPs to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care. During the second project phase, researchers will assess the impact of SUD IBH on PCP behaviors around adolescent SUD intervention. The investigators will interview and survey PCPs, clinic managers, and other clinical staff for willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward SUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based SUD services, the use of brief interventions for adolescents, number of consultation calls, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention. This project is supported by the HEAL Initiative (https://heal.nih.gov/).

Peer Recovery Support Services for Individuals in Recovery Residences on MOUD

The United States is experiencing an unprecedented opioid epidemic with a rapid increase in overdose deaths. Medications for opioid use disorder (MOUD) including methadone, buprenorphine, and extended-release naltrexone are efficacious and the recommended standard of care, yet barriers to sustained MOUD treatment reduce the overall efficacy of MOUD. Rates of MOUD retention are alarmingly low and MOUD dropout predicts opioid use/relapse, overdose, and death. While previous research has identified predictors of MOUD retention and adherence, there are no evidence-based interventions to improve MOUD retention. Recovery support services are a broad set of strategies to promote healthy outcomes among individuals with substance use disorder (SUD) that are typically separate from standard professional treatment. Among those strategies most utilized are peer recovery support services (PRSS) and recovery residences (RRs). PRSS include coaching, mentoring, education, and other supports delivered by individuals uniquely qualified by their lived experience with SUD. PRSS are increasingly utilized in a range of clinical settings, and advantages of PRSS include inherent shared understanding of addiction and a high degree of acceptance and understanding that is not found in most professional relationships. Existing research tentatively supports PRSS; however, the evidence to date is sparse and comes with significant methodological limitations and inconsistencies that make it difficult to conclude the efficacy of PRSS. No studies have examined the role of PRSS in promoting retention in MOUD. RRs provide a supportive living environment for persons in recovery from SUD and are widely utilized in the United States with an estimated 17,943 residences in 2020. Despite their proliferation, the evidence for RRs is only moderate and diminished by methodological weaknesses. Further, individuals on MOUD seeking housing through RRs often face increased MOUD-related stigma or may be disqualified from a RR for taking MOUD and need additional support to navigate these challenges. The potential synergistic benefits of combining PRSS and RRs to improve MOUD retention are considerable. PRSS and RRs are already mainstays in the recovery support services repertoire and could be leveraged to support MOUD retention. For example, more frequent, informal outreach typical of PRSS could facilitate regular monitoring of shifting attitudes and behaviors related to MOUD. The structure and accountability embedded in RRs could be used to support MOUD adherence and retention. Waxing and waning motivation to participate in MOUD treatment is common, and standard treatment is often unsuccessful at identifying early signs of future dropout or facilitating re-engagement after dropout. We will recruit participants on MOUD in RRs and provide them with PRSS using approaches such as recovery coaching and care navigation with a particular focus on supporting retention in MOUD care. PRSS will also provide assertive outreach between episodes of care, emphasize continuation in treatment and other recovery activities after leaving a RR (either successfully or unsuccessfully), and emphasize return to care after treatment dropout and/or relapse. The peers will be deeply embedded within the local provider community and care continuum to facilitate ease of care navigation. The ultimate goal of our research agenda is to test the efficacy of a PRSS intervention among individuals with OUD living in RRs through a rigorous trial. The eventual trial design would be informed by preparatory activities and experience proposed in this planning project. Preparatory activities proposed in this project include three major phases. Phase 1 - preparation for the intervention including: building a network of RRs that will be recruitment sites in the pilot RCT, recruiting and training peer support specialists, conducting focus groups and interviews to gather stakeholder input, and developing PRSS approaches to promote MOUD retention. Phase 2 - pilot test the PRSS intervention by randomizing N=50 individuals on MOUD recruited from collaborating RRs to either: a 24-week course of the PRSS intervention added to usual services, or usual services without the PRSS intervention. Phase 3 - gather additional input from former participants and RR staff post-intervention to further refine the intervention, and use lessons learned to inform our trial design and data collection procedures for the next-step R01 application.

VR Based Therapy to Treat Anxiety in Dual Diagnosis

Dual diagnosis refers to patients with both severe mental illness and substance abuse. Dual diagnosis is therefore a challenging condition to treat, and the group typically represents the most vulnerable individuals in society. Historically, research on dual diagnosis has been underprioritized, and thus, we still do not know enough about how to best assist this vulnerable group. However, new studies indicate that virtual reality programs can reduce anxiety in patients with psychotic disorders. They achieve this by providing access to a virtual therapist and lifelike environments where patients can challenge their thoughts about the dangers of navigating the world. For both psychotic disorders and substance abuse, we know that anxiety often plays a role in the clinical picture. Therefore, anxiety almost always has an impact on dual diagnosis patients, where it is crucial in maintaining substance abuse and functional impairment. Despite this, anxiety is rarely a focus in existing treatment options, as it is too resource-intensive in addition to an already intensive treatment process. This study investigates whether the resource barrier can be overcome and whether hospitalized dual diagnosis patients can experience reduced anxiety, fewer relapses, and better outcomes after discharge when their anxiety is treated through partially automated virtual reality therapy.