Clinical Research Directory

Peer Support Workers Study

Many people with high-risk opioid use visit emergency departments (EDs), facing a high risk of death if they leave before completing care. Peer support workers (Peers) - people with lived experience of substance use - may improve patient comfort, reduce early departures, and potentially lower mortality rates. This study aims to evaluate how a hospital-implemented ED Peer program can enhance patient support, reduce barriers to care, and provide harm-reduction resources in a person-centred and trauma-informed manner. The study will assess whether Peer availability and direct Peer-patient interactions are associated with improved ED care outcomes, including reduced leaving before treatment completion, as well as subsequent healthcare utilization, overdose, mortality, and other relevant patient outcomes.

Effects of Qigong Exercise on Anxiety and Depression in Patients Receiving Inpatient Treatment for Substance Use Disorder

Patients receiving inpatient treatment for substance use disorder may experience anxiety and depressive symptoms. Qigong is a mind-body exercise that combines gentle movements, breathing techniques, and relaxation. This study aimed to evaluate the effects of Qigong exercises on anxiety and depression levels. The study was conducted as a single-blind, randomized controlled trial. Patients meeting the predefined eligibility criteria were randomly assigned to either the intervention group or the control group. The intervention group participated in Shibashi Qigong exercises four times a week for three weeks (12 sessions in total), while the control group did not receive Qigong exercises. Both groups continued their usual treatments. Anxiety and depression levels were assessed using the State-Trait Anxiety Inventory (STAI) and the Beck Depression Inventory (BDI) at three time points: before the intervention, immediately after the three-week exercise program, and one week after its completion.

Justice Core Trial

The goal of this clinical trial is to learn if Justice Core, an intervention that moves pregnant women with substance use disorder (SUD) from jail into community-based SUD treatment while awaiting trial, can improve the health of pregnant women compared to referring them to treatment at the time of jail release. The main questions it aims to answer are: * Will the Justice Core intervention help women start and stay in SUD treatment compared to a group of women being given a treatment referral when they leave the jail? * How does the Justice Core intervention affect pregnancy health outcomes compared with a group that is given a treatment referral when they leave the jail? * What are the challenges in starting a new intervention, keeping it running, and the ethical issues during and after the trial? Researchers will compare the outcomes of women who receive the Justice Core intervention with women who receive a treatment referral when they are released from jail. They will look at how many women start and continue treatment and compare pregnancy-related and incarceration outcomes. Participants will be asked to: * Complete a treatment assessment. * Take part in three follow-up phone surveys. * Some participants may also be asked to complete a longer phone interview to share more about their experiences.

Open-Label Psilocybin Study in Transdiagnostic Population

The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

Predicting Dropout and Outcome From Neuropsychological Functions in SUD Patients

The aim of this project is to gain a more specific understanding of how different cognitive profiles predict residential treatment drop-out, treatment retention and post-treatment outcome in a population with Substance Use Disorder.

Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization

This study is a randomized controlled trial evaluating the impact of financial incentives on medication adherence among individuals with schizophrenia, schizoaffective disorder, or bipolar disorder and/or co-occurring substance use disorder who are recently discharged from involuntary hospitalization or are at high risk of future involuntary hospitalization. Participants will be randomized to receive financial incentives for adherence to long-acting injectable medications or to a control group.

Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music

FALCO is a parallel pragmatic randomized control trial addressing long-term effects of music therapy (MT) on substance use disorder (SUD). 600 participants will be recruited from multiple European countries (see Locations). They will be randomized into one of the following intervention arms: Active Music Group (AMG), Music Listening Group (MLG) or Treatment as Usual (TAU) as offered locally.

Research Investigating Drug Effects-2 (RiDE-2)

The purpose of this study is to better understand how people's mood, behavior, and brains respond to different recreational drugs. We are also trying to understand why some people may feel differently or their brain may respond differently than other people after taking the same recreational drug.

Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy

The goal of the RESHAPE study is to learn about the needs and experiences of adults who report having, or being at risk for, substance use disorder. The study will also evaluate engagement with an app-based program designed to support self-monitoring, goal setting, and well-being. The first part of the study will include adults who also report a health-related social need, such as food insecurity, housing instability, unreliable transportation, difficulty paying utility bills, or concerns about personal safety. The main questions this study aims to answer are: * What app features and educational resources do participants find useful? * How do participants engage with study activities, resources, and opportunities to track their substance use and well-being? * How do participants' reported well-being and substance use change over time? * How do activity measures, such as physical activity, sleep, and heart rate, change over time among participants who connect a wearable activity tracker? * How satisfied are participants with the RESHAPE program, and how willing are they to participate in future research? The study has two parts. In Phase 1, 8 to 10 participants will complete a recorded, 60-minute online interview, and approximately 400 other participants will complete a one-time online survey. Researchers will use this information to refine the app-based program. In Phase 2, participants will use the RESHAPE program for approximately one year. They will complete surveys and check-ins about substance use, cravings, well-being, goals, and social circumstances. Participants may also receive personalized graphs, educational resources, and insights based on study data. Those with a connected wearable activity tracker may share activity, sleep, and heart rate data. With their consent, information previously collected through the Evidation platform may also be linked with their study data.

Disease Intervention Specialist (DIS) for SUD

This prospective observational study evaluates three Disease Intervention Specialist service models designed to proactively identify and support adults at risk for substance use disorder. The models include substance use screening, motivational interviewing, case management, treatment referral, and optional peer support. The study will compare participant outcomes across the service models, including substance use severity, treatment engagement, overdose, service utilization, and satisfaction.

Recovery Management Checkup Scalability and Sustainability Hybrid Experiment

Individuals who are involved in the criminal-legal system (CLS) are at high risk of drug-related overdose; they also face significant barriers to engaging in substance use disorder (SUD) treatment and recovery support services. To address this public health challenge, this study will test the implementation and outcomes of an evidence-based intervention, Recovery Management Check-ups (RMC), delivered within community-based programs in four Chicago communities that have high rates of drug-related overdose and arrests. The study has the potential to increase uptake of RMC in community-based programs, thereby reducing overdose-related deaths and crime-related costs and improving individual health and community public health.

Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder

The researchers will test whether cognitively enhanced transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex can reduce craving in inpatients with cocaine use disorder or opioid use disorder. Neuroimaging before and after stimulation will establish the neural correlates of recovery and allow predictions of outcomes, which will be assessed throughout the study and one month after its completion. Results could pave the way towards development of a new self-administered intervention to reduce craving when it is needed the most, enhancing recovery real-time and in the natural environment in people with cocaine addiction as generalizable to other drugs of abuse and other disorders of self-control.

Reentry Assist (R-Assist)

This project will aim to develop and pilot test, R-Assist, a mobile health application to support individuals with co-occurring substance use and mental health disorders (COD) in their recovery, who have recently released from a participating Massachusetts jail.

Brave Heart Intervention and Mental Health Outcomes Among Young People in Sierra Leone

Young people in Sierra Leone face a growing crisis of substance use and mental health struggles, but the country has very few mental health professionals to help them, only a handful of psychiatrists and no psychologists for a population of over 8 million. At the same time, use of a synthetic drug known as "kush" has risen sharply among adolescents and young adults, and hospital admissions related to it have increased dramatically in recent years. The Brave Heart Intervention is a research study testing a different way of getting help to young people: instead of relying only on scarce specialists, the study trains teachers and community leaders to deliver substance use prevention education and basic mental health support themselves. This approach, known as "task-shifting," has worked well in other under-resourced settings and aims to make prevention services available in places, schools and neighborhoods, that young people already spend time in. The study will take place in Freetown, the capital of Sierra Leone. Forty secondary schools and four communities will take part. Half will receive the Brave Heart Intervention (the "intervention group") and half will continue with usual practice for now (the "control group"), with schools and communities assigned to each group by chance, similar to a coin flip. This design allows researchers to fairly compare outcomes between the two groups. The intervention itself combines three elements: sessions that teach young people to recognize and manage difficult emotions and thoughts (drawing on cognitive-behavioral techniques), training in practical life and digital skills, and work with local leaders and policymakers to support drug prevention efforts over the long term. Teachers and community leaders receive training and ongoing supervision so they can deliver these sessions safely and effectively. Participants are young people aged 10 to 24, along with the teachers and community leaders who help deliver the program. The study will measure whether young people's ability to refuse or resist substance use improves, whether their overall mental well-being and life satisfaction improve, whether their knowledge about substance use and mental health increases, and whether their confidence in handling life's challenges (self-efficacy) and everyday life skills, such as communication, problem-solving, and coping with stress, improve. The study will also ask teachers and community leaders about their own knowledge and confidence in delivering this kind of support, and will explore, through group discussions and interviews, how practical, acceptable, and sustainable this approach feels to the people involved. By testing whether trained non-specialists can safely and effectively deliver mental health and substance use prevention support, this study aims to help identify a scalable model that could be adapted more broadly across Sierra Leone and similar low-resource settings, where specialist care is difficult to access.

Coordinated Access for Addiction Recovery and Equity in VA Supportive Housing

The Department of Housing and Urban Development-VA Supportive Housing (HUD-VASH) Program provides subsidized permanent housing with case management to homeless-experienced Veterans (HEVs). Up to 40% of Veterans exit HUD-VASH within two years of attaining housing; substance use disorders (SUDs) are one of the largest causes of returns to homelessness for HEVs. CARE-VASH QUERI proposes to implement and evaluate two evidence-based SUD services - Medications for addiction treatment (MAT) and cognitive behavioral therapy for SUDs (CBT-SUD) - among Veterans in HUD-VASH.

Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community

Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction. Objectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems. Methods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up. A cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.

Youth Overdose & Use Reduction in Rural Systems

The goal of this study is to conduct a clinical trial to understand effects of providing multilevel intervention to young people in the legal system. The multilevel intervention includes flexible care management using ACRA/ACC principles, family support, and overdose education. This study aims to test the implementation strategy, as well as the outcomes of the intervention with participants. The first question the study will address is how successful was implementation. This will be measured by the number of youth receiving case management, family support, naloxone supplies, and overdose prevention curricula, and adoption by the participating county court systems. The second question the study will address is whether the intervention impacted youth behavioral outcomes, such as overdose risk awareness, knowledge of how to use naloxone, and number of days per month using substances. Researchers will compare youth who received the intervention to youth who received usual treatment to see if the intervention increases overdose risk awareness and knowledge, and decreases frequency of substance use. Participants will receive the intervention (if assigned to) and complete study surveys. Participating counties will provide data on implementation, and site visits will also be performed to track each county's performance.

Contextualization and Digitalization of WHO's Mental Health Action Gap Intervention Guide Substance Use Disorders Module

The aim of study is to: 1. To contextualize, adapt, customize and digitalize WHO's Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG); Substance Use Disorders Module (SUD module) V 2.0 for primary care settings (PCPs) in Pakistan. 2. To test the feasibility and acceotability of the e-mhGAP-IG (SUD module) training program in a feasibility cluster randomized controlled (cRCT) trial to enable mental health services in primary health care settings in Pakistan. The proposed study includes contextualization, adaptation, customization, and a feasibility cRCT of e-mhGAP-IG (SUD module) V 2.0 by constituting a combination of traditional and technological approaches of eHealth (mHealth, blended learning, and telemedicine) enabling mental health services in primary care settings to be well informed and accessible. This intervention will empower 300 Primary Care Physicians (PCPs) based in Primary Care Units (PCUs) from urban settlements and Basic Health Units (BHUs) from rural settlements in three major cities, Karachi, Lahore, and Rawalpindi, Pakistan.

Wellness, Intervention Strategies and HIV Care

This is a pilot trial designed to assess the feasibility and acceptability of an intervention aimed at improving adherence to antiretroviral therapy (ART), viral suppression, and engagement in HIV care. The intervention will address behavioral coping strategies, HIV care engagement behaviors, and substance use management.

Real-time Opioid Study

This feasibility study collects initial data on the use of an fMRI neurofeedback protocol for treating anhedonia in methadone-treated individuals with opioid use disorder (OUD). The intervention tested has previously been shown to reduce anhedonia in individuals with depression and this study is collecting first-in-human data in an OUD population. Investigators will assess tolerability of the intervention and collect preliminary data from 2-3 subjects monitoring changes in anhedonia, non-substance-related autobiographical memory recall, and meaning in life.

Auricular Vagal Neuromodulation for Depression and Anxiety in Substance Use Disorder

This pilot study will evaluate whether home-based auricular vagal neuromodulation therapy (AVNT) is practical, acceptable, and well tolerated for adults receiving treatment for substance use disorder. Participants will use a handheld device that delivers mild electrical stimulation to the ear for approximately 60 minutes each day over 30 days. Researchers will examine whether participants can successfully use the device as directed and complete study procedures. The study will also explore whether use of the device is associated with changes in depression, anxiety, sleep problems, and substance craving.

Project SHIELD 2.0: Police Education to Support Public Health in Kentucky

The project is a pragmatic, quasi-experimental hybrid type II effectiveness-implementation trial of a structural HIV prevention intervention to address police behavior (arrests and referrals) and ultimately improve health among people who use drugs. The study involves a novel implementation strategy that engages behavioral health workers as "local champions" in the delivery of an evidence-based police education program (SHIELD training intervention). In addition to examining implementation outcomes, primary outcomes focus on assessing effectiveness of the intervention among police (specifically in reducing drug-related arrests and promoting referrals to Medications for Opioid Use Disorder (MOUD) treatment. The investigator's overarching effectiveness hypothesis is that after law enforcement organizations receive the SHIELD training intervention, the organizations will be more likely to refer people who use drugs to MOUD treatment and other health and social services, rather than arresting for low level possession offenses. The study will be conducted across different counties in Appalachian Kentucky.

Substance Use in Pregnancy - Optimizing Retention in Treatment

Substance use during pregnancy is a leading cause of maternal morbidity and mortality in the United States, with 55-80% of postpartum patients disengaging from substance use disorder (SUD) treatment within one year of delivery. Structural and social determinants of health, including housing instability, transportation barriers, and limited childcare access, further exacerbate disparities in treatment retention. This pilot study, conducted in two specialized prenatal care clinics, evaluates the feasibility and acceptability of two integrated strategies to promote sustained engagement in recovery-oriented services during the perinatal and postpartum periods. Aim 1 implements a standardized social needs screening and referral protocol to connect patients with community-based supports. Aim 2 pilots a contingency management intervention to incentivize recovery-supportive behaviors. Findings will inform the design of a larger multi-site randomized controlled trial to evaluate the impact of these interventions on treatment retention, overdose prevention, and maternal-infant health outcomes.

Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial

The purpose of the current research study is to evaluate the efficacy of the refined Written Exposure in Substance Treatment (WEST) for PTSD among residential SUD patients through a randomized controlled trial. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. Participants will be randomly assigned to WEST + treatment as usual (TAU) or TAU only. The primary outcome is change in PTSD symptoms from pre-intervention to post-intervention. The secondary outcome will be change in SUD outcomes (e.g., treatment completion, reduced opioid and other drug use) and change in non-PTSD mental health outcomes (e.g., depression) from pre-intervention to post-intervention.