Clinical Research Directory

Neuroimaging of Adolescent Cannabis Use Treatment

This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free.

Clinic-level Implementation of mHealth to Improve HIV Viral Suppression for Patients With Substance Use Disorders

The current protocol aims to enroll up to 806 participants from 8 study sites in a clinic-supported intervention which will connect them to Vivent Health care team and a cohort of peer mentors for a year-long intervention period to support patient HIV care to maintain viral suppression and clinic appointments.

Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People

This is a multi-phased study, funded through a National Institute on Drug Abuse (NIDA) K24 grant that aims to ultimately refine a virtual reality tool through qualitative and quantitative research targeting HIV and substance abuse risk behavior among at-risk young people who have experienced psychosocial trauma. Participants eligible for this study include young men who have sex with men (YMSM)/individuals who are romantically/physically attracted to men and adolescents with substance use disorder (SUD) between the ages of 15 - 30 and have experienced at least one traumatic event in their lifetime. Frontline healthcare workers who work within these populations are eligible for the study as well.

Enhancing Addiction Treatment Through Psychoeducation

Addiction is a brain disorder characterized by a broad range of both apparent and subtle cognitive impairments in attention, memory, executive functions, and decision-making. These cognitive problems are clinically significant and may contribute to poor treatment outcomes in people with Substance Use Disorders (SUDs), such as a high risk of dropout, low treatment compliance, and shorter periods of abstinence. Studies on cognitive function in SUDs reveal that chronic use of drugs and alcohol can also negatively affect another crucial component of cognition: awareness, or metacognition. Metacognition is defined as an individual's ability to perceive and understand their cognitive functions and use this understanding to regulate them. One of the key consequences of metacognitive impairments is the lack of insight in people with SUDs, which adversely affects treatment outcomes. Substance users with poor metacognition are more reluctant to initiate or continue treatment and are more likely to deny their cognitive problems. Therefore, improving metacognition may remove or reduce motivational barriers to invest time and effort in the recovery process in general, and in the brain recovery process specifically. Despite the importance of neurocognition and metacognition in the recovery process for substance users, there is a dearth of interventions designed to target these functions.

Characterization of Phenotypic and Genotypic Regressors for Imaging

The influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Researchers are interested in looking at the genetic information of individuals who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic variants that may be related to substance abuse. Researchers will study the effects of genes on several aspects of thinking such as attention, memory, decision making, problem solving, learning, and emotional feelings, and investigate the ways in which genetic information affects addictive behaviors and substance abuse. In addition, researchers will study how genes may explain differences in imaging data in substance users. Objectives: \- To collect genetic information for research on genetic aspects of addiction and substance abuse. Eligibility: * Adults age 18 or older * (1) healthy, non-drug-using nonsmokers, * (2) healthy smokers, * (3) healthy individuals dependent on other commonly abused drugs, and * (4) individuals with other psychiatric disorders. * Participants must be enrolled in another National Institute on Drug Abuse, Intramural Research Program imaging protocol. Design: * This study involves one to two visits to National Institute on Drug Abuse, Intramural Research Program that may be separate from the participant's current research protocol study visits or on the same day as those visits. * Participants will provide a blood sample and complete questionnaires about mood, memory, and learning. * Participants may also be asked to do a few tasks, such as playing computer games involving coin tosses and money management, or responding to questions on a computer screen.

Pragmatic RCT of SBIRT-PM

Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. The Investigators propose to test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM), designed to reduce pain and reduce risky substance use, in part by helping Veterans get comprehensive pain treatment. The study will involve clinicians at a single site contacting Veterans throughout New England by phone to deliver SBIRT-PM counseling in a pragmatic, randomized, clinical trial.

tAN for Substance Use Disorder

The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.

Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

The goal of this clinical study with research procedures is to learn how stopping and restarting tirzepatide (a medication that helps regulate blood sugar and appetite) affects brain activity, behavior, and health in adults ages 18-70 who are currently taking tirzepatide. Specifically, the study aims to examine how a short pause in tirzepatide affects hunger, mood, sleep, and daily functioning; how stopping and restarting tirzepatide alters brain chemistry and brain responses to food-related images; and how these changes relate to health measures such as quality of life and emotional well-being. There is no comparison group; instead, researchers will assess changes within each participant across three time points: while taking tirzepatide, after stopping it for 3-4 weeks, and after restarting it for 6-8 weeks. Participants will attend three in-person visits lasting approximately 3-4 hours each, during which they will complete interviews, questionnaires, and cognitive tasks; provide a urine sample (pregnancy screening for females); undergo a brain scan using magnetic resonance imaging (MRI) and MR spectroscopy (MRS); and receive a kit to provide a small stool sample. Participants will also complete two brief check-in phone calls between visits and the online BrainHealth Index between sessions, which includes surveys and cognitive tasks. All changes to tirzepatide use will occur under the supervision of a study physician to support participant safety and comfort, and the total study duration is approximately 13 weeks.

Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic

"Gold-standard" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide "whole-patient" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent. This study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.

Efficacy of an EMDR App for PTSD and SUD

The current proposal is aimed to confirm the efficacy of this novel therapeutic method (autonomous eye movement desensitization and reprocessing; A-EMDR) in a patient group (PTSD and SUD), and to assess the feasibility of the application within this group. While there is no basis to assume lower efficacy of the treatment with this population, confirming that hypothesis is an important and helpful step before a full-performance research study can be initiated. Furthermore, this study proposal will provide additional information regarding the feasibility for this population, which will allow for a more tailored approach in future study.

Senyo Health With Substance Use Disorder (SUD) in Primary Care

The purpose of this study is to examine the barriers, facilitators, and optimal processes for implementing a digitally enhanced screening, brief intervention, and referral to treatment (SBIRT) model for Substance Use Disorder SUD treatment among Mayo primary care clinics.

The Collaborative Care PrTNER Study

A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young aged 15 to 29 through engagement in SU treatment.

Mitigating the Impact of Stigma and Shame Among People Living With HIV and Substance Use Disorders

People living with HIV and substance use disorders (SUDs) are less likely to be virally suppressed, which can lead to HIV transmission and negative health outcomes. This hybrid type 1 study will assess the efficacy, mechanisms, as well as facilitators and barriers to implementing the MATTER intervention, a virtually delivered 5-session text-enhanced psychobehavioral intervention designed to facilitate viral suppression by addressing internalized stigma and shame as barriers to engagement in HIV care among individuals living with HIV and SUDs in two locations with different levels of HIV resources (i.e., the Boston, Massachusetts and Miami, Florida metro areas). MATTER aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) developing behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of emotions and cognitions), and c) teaching and reinforcing compassionate self-restructuring (i.e., self- compassion), in addition to providing access to phone-based resource navigation. Scalable interventions such as MATTER are essential to our efforts to end the HIV epidemic in high priority regions.

Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder

The purpose of this research study is to investigate the safety and feasibility of two (2) oral doses of psilocybin when combined with behavioral support for methamphetamine use disorder (MUD). Participants have a diagnosis of methamphetamine use disorder (MUD). Participants can expect to be actively engaged in the study for up to 26 weeks.

Feasibility of an Interdisciplinary Intervention to Improve Care Transitions for Hospitalized Patients With Substance Use Disorders

The purpose of this study is to evaluate the feasibility and preliminary effectiveness of a primary care-based Interdisciplinary Addiction Care Transition (IntACT) team that will meet patients with substance use disorders (SUD) during a medical hospitalization and provide intensive care management, peer support, and interim SUD and medical care after discharge while facilitating a transition to long term community-based treatment.

Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients

The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting. This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit.

Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization

Investigators will test a novel protocol for starting BUP (buprenorphine-naloxone) treatment. The BUP microdose induction protocol has participants start very low doses of BUP without stopping other opioids that they are taking. The treatment as usual (TAU) has participants stop other opioids and experience opioid withdrawal before starting BUP. Investigators propose to test BUP microdose inductions vs. TAU in a randomized controlled trial.

Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion

The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative affect, craving, and opioid withdrawal) in OUD subjects currently in MOUD treatment with buprenorphine.

Minds and Mentors Program- R33

The proposed research effort will: The purpose of this study is as follows: 1. Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals using medications for opioid use disorder (MOUD) will be randomized in blocks of five to receive either the Minds and Mentors Program (n=120) or Twelve Step Facilitation (n=120). 2. Determine whether the MiMP: a) improves adherence to MOUD b) reduces the rate of relapse and cravings c) decreases self-reported anxiety, stress, and depression and d) reduces cortisol levels and cortisol reactivity to drug cues. 3. Examine whether pre-intervention cortisol reactivity is predictive of relapse outcomes, and/ or reductions in cortisol reactivity over the course of intervention mediate relapse outcomes.

Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)

The objective of this pilot intervention study is to iteratively refine motivational interviewing and psychosocial intervention programs delivered via telehealth (Teletx) to help improve substance use and other related outcomes in SUD patients who are not receiving SUD care. We will examine feasibility and acceptability of these pilot psychosocial programs in a total of n=50 participants. The goal is to refine the programs to improve acceptability and feasibility and collect preliminary data for a future fully powered randomized controlled trial (RCT) in the future. In addition to study sessions, participants that are enrolled in the study will complete surveys prior to, during, and after treatment.

Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)

This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.

Recovery Inspired Support Engagement (RISE) Pilot

The goal of this clinical trial is to learn if a 1-on-1 support program is easy to complete and acceptable for people supporting loved ones who have recently received treatment for substance use. The main questions it aims to answer are: How many people complete the program? How satisfied are people with the program? Participants will: Complete weekly telehealth sessions for 12 weeks Complete surveys/interviews at the beginning, in the middle (\~week 6), at the end of the program (\~week 12), and 12-weeks after the end of the program Complete a focus group or interview

The Canadian Underage Substance Use Prevention Trial

Despite having made some strides with respect to reducing adolescent drinking rates, illicit substance use and substance use disorders (SUDs) remain significantly above national targets for health promotion and disease prevention in Canada and the United States. Now, more than ever, there is a pressing need for effective substance abuse prevention in Canada, particularly for those most at risk of developing substance use problems including prescription drug misuse. Clearly, new approaches to prevention (with lower numbers needed to treat) are needed and which translate new research on addiction vulnerability to personalised prevention and early intervention. The PreVenture Program involves brief cognitive-behavioural interventions targeting personality traits from a neurocognitive perspective. While the personality-targeted approach has been shown to be effective in reducing most substance use behaviors, it has yet to be evaluated for its impact on uptake of prescription drug misuse in adolescents. The Canadian Underage Substance use Prevention (CUSP) Trial aims to evaluate the long-term effects of a personality-targeted school-based prevention program on delaying the onset of drug and alcohol use in adolescence over three years across Canada. This is a hybrid effectiveness \[E\] and implementation-facilitation \[IF\] trial on delaying the onset of drug and alcohol use in adolescence. In the \[E\] part, the effects of a personalized prevention program will be tested against usual school-based prevention curricula. PreVenture is delivered through a TtT implementation model with or without \[IF\], e.g. with ongoing supervision and web-based support. The \[IF\] package is designed to support long-term sustainability of PreVenture after a community accesses PreVenture training.

EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented.