Clinical Research Directory

NLP Analysis of Weekly Narratives for Dynamic Clinical Assessment in SUD

This prospective observational study follows adults undergoing residential rehabilitation for severe substance use disorders at a specialized treatment center in Mexico. Participants provide weekly written narratives describing their emotions, challenges, coping strategies, and treatment experiences, and complete validated psychological questionnaires every two weeks, including the Generalized Anxiety Disorder-7 (GAD-7), Environmental Reward Observation Scale (EROS), Automatic Thoughts Questionnaire-8 (ATQ-8), and Behavioral Activation for Depression Scale (BADS). The study applies natural language processing (NLP) and machine learning methods to analyze participants' narratives and identify emotional, cognitive, and behavioral patterns associated with clinical change over time. Narrative-derived features are combined with questionnaire scores to generate a dynamic clinical risk representation that may help detect early signs of psychological worsening or improvement during residential treatment. Participants continue receiving standard residential care, and the study does not modify treatment decisions or clinical interventions. Up to 35 participants with sufficient longitudinal follow-up data will be included in the primary analysis. Data collection is expected to continue through September 2026.

A Study to Investigate Health Related Quality of Life With a Pharmacist Intervention Compared to Treatment as Usual in Participants With Severe Mental Illness and Substance Use Disorder Receiving Treatment From FACT Teams.

The study aims to evaluate the impact of integrating a clinical pharmacist into Flexible Assertive Community (FACT) teams on health-related quality of life and pharmacotherapy for individuals with severe mental illness and substance use disorders. This is a pragmatic effectiveness study using a stepped wedge cluster randomized trial design. Four FACT teams from FACT Innlandet will serve as clusters, transitioning from standard care (control) to intervention in a randomized sequence. The intervention involves integrating a clinical pharmacist into the interdisciplinary FACT teams. Participants will be adults (over 18 years old), receiving treatment from participating FACT teams, diagnosed with severe mental illness or substance use disorder and prescribed at least one psychotropic medication. Exclusion criteria include inability to provide informed consent, planned discharge within the first three months of period 1, or inability to communicate in Norwegian or English. The control group receives standard care provided by FACT teams. The intervention group will have a clinical pharmacist integrated into the FACT team performing medication reconciliation, comprehensive medication reviews, patient counselling, and interdisciplinary discussions to resolve medication-related problems. A sample size of 160 patients is estimated based on an effect size of 0.25, 80% power and alpha=0.05. The primary endpoint is change in patient-reported health related quality of life, measured using the EuroQoL-5 dimensions-5 levels (EQ-5D-5L) and Visual Analog Scale, EQ-VAS scores from baseline to the end of the intervention.

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.

Behavioral Rigidity in Residential Treatment for Substance Use Disorder (RIG-TD)

Behavioral rigidity, the tendency to maintain inflexible patterns of thinking and acting despite changing circumstances, is a common feature in substance use disorders, depression, and anxiety. This observational study aims to measure behavioral rigidity as a dynamic, transdiagnostic process in patients undergoing residential treatment for substance use. Using a longitudinal intensive repeated-measures design, participants complete weekly assessments of cognitive reactivity (Automatic Thoughts Questionnaire-8 item version, ATQ-8), behavioral activation (Behavioral Activation for Depression Scale, BADS), and experiential avoidance. A Behavioral Rigidity Index (BRI) is derived from these measures. Additionally, natural language processing (NLP) is applied to therapy session transcripts to quantify linguistic absolutism (e.g., use of words like "always," "never") and affective polarity. Bayesian multilevel models examine whether rigidity predicts current and next-week clinical status. The study also explores whether linguistic markers add unique predictive value beyond self-reports. Results may inform personalized monitoring and interventions targeting psychological inflexibility in addiction treatment.

Continuing Care for Justice-involved Individuals

The goal of this open label feasibility trial is to determine the feasibility of using a mobile continuing care app to augment community treatment for individuals under justice supervision receiving community substance use disorder treatment.

Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START

The goal of this observational study is to learn about the roles played by parental activity spaces and social networks in reducing parental substance use and promoting child and family health outcomes in the context of Ohio START (Sobriety, Treatment, and Reducing Trauma) for families in rural areas. This study will investigate if substance use treatment service referrals and family peer mentoring services provided by Ohio START lead to positive changes in parental activity spaces and social networks, and if these positive changes lead to better child and family outcomes. The main questions it aims to answer are: * Does having behavioral health services (referred by Ohio START workers) close to where parents spend their time help with substance use recovery and child health? * Does peer mentor support through Ohio START help parents build stronger social connections and family resilience, and does this lead to better long-term family health? * Do these associations differ in rural areas compared to urban areas? Participants will: * Answer survey questions about their substance use, parenting, child health, and family well-being across three waves (Wave 1: when they enroll in the study, Wave 2: 6-month follow-up, and Wave 3: 12-month follow-up) * Share information about places they go regularly (such as work, stores, and healthcare visits) * Share information about people in their support network

WORTH Paths Intervention

Women in the criminal legal system are more likely to experience substance use disorders and unintended pregnancy than women in the general public. However, they often face barriers to accessing substance use treatment and sexual and reproductive health services. This study tests the feasibility and acceptability of Women on the Road to Health (WORTH) Promoting Access to Treatment, Health, and Support (Paths), a digital intervention adapted from the evidence-based CDC Best Practice HIV prevention intervention, Women on the Road to Health (WORTH), originally developed at Columbia University School of Social Work. WORTH Paths is designed to help reproductive-aged women in the criminal legal system with substance use disorders and unmet need for contraception reduce drug use and improve contraceptive use. Participants (N=50) will be randomly assigned to one of two groups: WORTH Paths Intervention Group - Participants will attend three virtual group sessions with facilitated videoconference sessions and self-paced digital activities focused on reducing drug use and increasing contraceptive use. They will also receive guidance on how to access and navigate health services. Control Group - Participants will receive a virtual general wellness program that includes education on substance use and sexual and reproductive health but does not include skills-based training related to these topics. The focus will be on general wellness and stress reduction. Both groups will receive resources for substance use treatment and sexual and reproductive health services. Researchers will track changes in drug use and contraceptive use over three months. Participants will complete surveys and provide urine samples to confirm changes in drug use. Primary aims: Feasibility: Measured by session attendance, treatment completion, dropouts, and reasons for termination. Acceptability: Measured by participant ease of use, helpfulness, and satisfaction. Primary behavioral outcomes: Self-reported drug use confirmed by urine drug tests. Contraceptive use, including initiation and consistent use. Secondary behavioral outcome: Linkage to substance use disorder treatment (measured by appointments made and sessions attended).

Combining Social Network Strategies and Routine Substance Use Screening

This study aims to improve health care for people who may have HIV or substance use disorders by bringing two services to a large community health center in Chicago. First, the clinic will begin offering routine screening for substance use to all patients. Second, the study will offer a social network-based program that helps people identify friends or partners who may need support and link them to care. The goal is to help more people learn their HIV status, reduce HIV levels in the community, and connect people with substance use treatment when needed. The study will also look at how well these services can be added into everyday clinic practice and what is needed to keep them going over time.

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.

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.

HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders

Substance use disorder (SUD) or addiction to drugs/alcohol is a devastating disease. Over 40,000 overdose deaths have happened in Canada since 2016, 1 in 5 Canadians will have a SUD, and 70% of those with SUD continue to relapse, showing that we urgently need new treatments. The Helping Addiction by Individualized Therapeutic Stimulation (HABITS) Study is exploring deep brain stimulation (DBS) for people who have failed to quit harmful substances. Over 250,000 people have received DBS, which is well-established for Parkinson's disease and has evidence of success in major depression and obsessive-compulsive disorder. DBS uses electricity to directly stimulate areas of the brain. However, for DBS to work effectively, it needs to be personalized to each individual, which will be pursued through stereoelectroencephalography (SEEG). DBS and SEEG are minimally invasive and reversible, with a low risk of side effects. SEEG started over 70 years ago to find seizure location in the brain of children and adults with epilepsy. It now has been used for major depression and chronic pain to guide DBS. It involves inserting electrodes temporarily across critical brain areas and monitoring patients for several days. SEEG can provide an understanding of where addiction and craving are in the brain to guide the placement of DBS electrodes and device settings that are optimal for a person. In the HABITS Study, 10 participants will receive DBS guided by SEEG and undergo 11 study visits. Individuals will first undergo detoxification with CAMH. Then, they will receive DBS and SEEG at Toronto Western Hospital, where they will stay for 1 to 2 weeks. Finally, they will be followed for a year, where they will receive standard psychiatric care. SUD causes heavy burdens on individuals, families, healthcare systems, and society. The HABITS Study promises to personalize DBS to treat those who are struggling with severe addiction.

Adolescent Stress and Substance Intervention Subsequent to Trauma

The long-term goal of this study is to address the adoption of the new trauma center requirement to establish best practices of screening for acute stress with an intervention to prevent both adolescent PTSD and substance use. The investigators will develop, refine, and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video interventions that build upon the American College of Surgeons Committee on Trauma guidelines to improve mental health care during and after hospitalization for traumatic injury. The aims are: PHASE I - Primary Aim 1: To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center. PHASE II * Primary Aim 2a: To evaluate the feasibility, acceptability and implementation potential of the ASSIST video interventions. * Primary Aim 2b: Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders. Participants in PHASE 1: Parent and child duo: * Review storyboards for the video interventions * Participate in qualitative interviews at hospital admission and 1 month following discharge Pediatric trauma center clinical staff members: \- Complete qualitative interviews Participants in PHASE II: Parent and child duo: * Shown their own video interventions * Complete assessments at admission and 1-, 2-, 3- months after discharge

Pathways to Perinatal Mental Health Equity

Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, "Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.

Implementation of TBI-RECOVER in Substance Use Treatment

The goal of this hybrid type 2 pilot trial is to understand the implementation and effectiveness of the TBI-RECOVER intervention model (e.g., brain injury screening, cognitive and behavioral challenges screening, and neurocognitive accommodations) on patient retention in outpatient substance use disorder treatment. We will evaluate whether an implementation strategy bundle (e.g., training/education, champions, audit \& feedback, facilitation) improves provider use and sustainability of the TBI-RECOVER intervention, and also whether the TBI-RECOVER intervention improves patient symptoms and treatment retention.

Evaluation of the ADD'Pro Vocational Reintegration Program (ADD-PRO-EVAL)

The goal of this clinical trial is to evaluate whether an integrated medico-psychosocial vocational support program (ADD'Pro) can improve employment outcomes in adults with substance use disorders receiving care at a specialized addiction day hospital. The main question it aims to answer is: \- Does participation in the ADD'Pro program increase the rate of competitive employment (at least one day worked in the open labour market) at 6 months compared to standard employment services? Researchers will compare participants enrolled in the ADD'Pro program to participants referred to conventional employment services (France Travail or Cap Emploi) to see if structured, dual medico-psychosocial support leads to higher rates of vocational reintegration, better employment preparation, improved quality of life, and reduced physiological stress reactivity. Participants will: * Be randomly assigned to either the ADD'Pro program or standard employment services * If assigned to ADD'Pro: receive immediate individualised support from a vocational counsellor (CIP) at the CeCler Association, running in parallel with their hospital addiction care, with no fixed end date * If assigned to standard care: be referred to conventional employment services with monthly follow-up interviews at the hospital, and the option to join ADD'Pro after 6 months * Complete structured interviews and validated questionnaires at inclusion, 3, 6, and 12 months * A sub-sample of up to 50 participants will additionally take part in a simulated job interview stress test (adapted TSST) with salivary biomarker collection and heart rate monitoring at inclusion and 6 months

California MEPS Hub

The California Hub for HIV/SUD Prevention Research with Reentry Populations addresses the question: "Can the evidence-based MEPS intervention be adapted and implemented at a range of organizations to effectively serve a wider range of clients?" The Mobile Enhanced Prevention Support (MEPS) intervention was originally implemented in Los Angeles County and was proven successful in promoting biomedical HIV prevention (PrEP) uptake and preventative screenings in people who used drugs who recently left incarceration. MEPS is an evidence-based intervention for people with substance use disorders (SUD) that incorporates a client-centered planning session, including trained peer mentors, service utilization incentives, and a mobile application (GeoPass). The study includes a randomized controlled trial (RCT) across three community partners located in Riverside and Alameda Counties. At least 300 people will be enrolled in these three counties; the first 200 will be randomized to either receive the intervention or usual care, with the final 100 all receiving the intervention. The primary implementation outcome for the study involves using an implementation science framework and assessment tools to examine MEPS's implementation. Key outcomes include how well the implementation strategies used support intervention enrollment and retention, integration with existing services in each partnering community agency, and perceived intervention acceptability, feasibility, appropriateness, and maintenance at 6- and 12-months. The primary effectiveness outcome for the study is an increase in HIV testing, PrEP uptake and adherence, and SUD service utilization at 6 months and 12 months in the MEPS compared to the usual care group. Secondary effectiveness outcomes include frequency of service use for SUDs, hepatitis C virus testing, and linkage to care for those who test positive for HIV or hepatitis C.

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.

Identifying Substance Use Consequences

The goal of this study is to develop a new tool for measuring substance use disorder treatment outcome. We will start by interviewing people and gathering advisory groups to develop the items for this new tool.

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.

The Trans-Led Care Study

This study is testing a new mutual-help group called "the TLC program" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or "ACT" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.

Unified Junction of Care, Integrated Treatments and Team Coordination for ADHD in Prison Settings With Substance Use Disorder

Substance use disorders (SUD) and attention deficit disorder with or without hyperactivity (ADHD) are frequently co-morbid, particularly among people under court supervision. The coexistence of these disorders increases the social and legal vulnerability of individuals. Better identification of ADHD in vulnerable people with SUD is essential to improving their care. This project aims to provide appropriate support for this at-risk population.

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are risk for HIV through known sexual risk.

Correctional Service of Canada Pilot Trial of Digital Substance Use Disorder Interventions (PROCESS)

Problems with substance use are common in prisoners. Since most substances are still illegal in Canada, substance use problems can increase the risk for re-incarceration. Although research suggests that treatment may reduce these risks, they are still rarely used in correctional settings. This pilot study will examine the feasibility and usefulness of two digital treatments for substance use problems in individuals recently released from prison. The investigators will compare engagement across both treatments over a 6-month period, and assess the rates of substance use relapse and re-incarceration.

Calls and Coordination for Transitions of Care at Re-entry

The goal of this clinical trial is to learn if a short program for people being released from prison can help connect them to medical care. The main question it aims to answer is: * Will there be more non-emergency, outpatient clinic visits? Researchers will compare the number of clinic visits between people who use a Nurse Case Manager (NCM) to people in enhanced usual care. Participants will: * Complete surveys * Talk to a study team member 2-3 times, or talk to a study team member 2-3 times and talk to an NCM 6-11 times