Clinical Research Directory

Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples.

Probenecid Administration for Alcohol Craving and Consumption

This study proposes a 16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g /day) compared to placebo in individuals with AUD to test if reduces craving and alcohol consumption.

Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder

The proposed project will include enrollment of 200 daily tobacco cigarette users, ages 22+, from the San Diego community. Participants will be assessed on the VR Nicotine Cue Exposure paradigm then randomized (stratified on age and sex) to receive varenicline (target dose 1mg twice daily) or placebo (n per group=100; total N=200). Following eight days of titration, participants will be assessed again on the VR Nicotine Cue Exposure paradigm. They will then be followed via mobile assessments for eight days on target dose of varenicline, and 30-days post assessment by phone, to assess short-term nicotine use behaviors.

Endotoxin Exposure to Examine the Role of Inflammation in Alcohol Use

The study design consists of a randomized, double-blind, placebo-controlled study of low dose endotoxin. Individuals with current AUD (n=32) and matched controls without AUD (n=32) will be randomly assigned to receive a single intravenous (I.V.) infusion of either low dose endotoxin (0.8 ng/kg of body weight) or placebo (same volume of 0.9% saline solution) to determine the acute and protracted role of inflammation in alcohol use.

tDCS for Social Media Addiction

The goal of this clinical trial is to learn whether transcranial direct current stimulation (tDCS), a non-invasive brain stimulation, can reduce "craving" and problematic levels of social media/internet use in university students. The main questions it aims to answer are: * Does active tDCS reduce craving to use social media during the intervention period compared with sham stimulation and no stimulation? * Does active tDCS reduce internet/social media addiction severity (measured with the Internet Addiction Test, IAT) compared with sham stimulation and no stimulation, and are any effects still present at follow-up? Researchers will compare three groups-active tDCS, sham tDCS (a simulation where stimulation is stopped after the first seconds), and a control group (no stimulation)-to see whether changes are due to tDCS rather than placebo effects or time. Participants will: * Complete an initial screening and baseline questionnaires (a sociodemographic questionnaire and the IAT). * Be randomly assigned to one of three groups: active tDCS, sham tDCS, or control (no stimulation). * Complete the IAT again after the intervention and again about 5 weeks later (follow-up), along with questions about social media use habits. During intervention, participants in active tDCS and sham tDCS will: * Attend 10 sessions over 2 consecutive weeks (Monday-Friday), with each session lasting about 30 minutes; mobile phone use is not allowed during sessions. * Rate craving on a Visual Analogue Scale (VAS) at the start and end of each session. This study will be conducted with university students in the Greater Lisbon area and will follow double-blind procedures for the active vs sham conditions (participants and researchers will not know the assigned condition until the end of the study).

State-dependent Interoception, Value-based Decision-making, and Introspection

Background: Negative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders. Objective: To learn how negative emotions affect the brain and decision-making behavior. Eligibility: Healthy people aged 18 to 55 years. Design: Participants will have 3 clinic visits in 3 weeks. Participants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind. For 2 visits, participants will be assigned to different groups. Each group will experience 1 type of emotional stressor: Some participants will watch a video. Some will have to do arithmetic problems. Some will have heat applied to an arm or leg. Some will experience cold by immersing their hand in ice water. For a snack craving test, some will be tempted by food after a 4-hour fast. During these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected. After the stressors, participants will do tasks on a computer. They will need to make choices. Some participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain. ...

Examining the Effectiveness of Dynamic Visual Noise (DVN) for Reducing Alcohol Cravings and Consumption in College Students

The goal of this clinical trial is to examine whether dynamic visual noise (DVN), a short video array of rapidly moving black and white squares, reduces cravings for and consumption of alcohol in college students who drink alcohol and experience cravings for alcohol at least once a week on average. A second goal of this clinical trial is to examine whether changes in attentional bias towards alcohol (that is, the tendency to pay greater mental and visual attention towards alcohol over other things in one's environment) is a mechanism by which DVN reduces alcohol cravings and consumption. Researchers will compare DVN to static visual noise (SVN), which is a still image of black and white squares that has been used as a control condition for DVN in prior literature. Participants will: 1. Visit the laboratory once to complete the baseline data collection 2. Watch the DVN or SVN every day for seven days (including the day of the laboratory visit) 3. Complete daily follow-ups for six days following the day of the laboratory visit 4. Complete a final follow-up on the seventh day following the laboratory visit

Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.

The hypothesis is that the increase in dlPFC brain activity via near-infrared spectroscopy-based Neurofeedback (fNIRS-based NF) training based on near-infrared spectroscopy would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects. Patients will be trained during a month with 8 NF sessions and results based on clinical data and different questionnaires results will be compared between inclusion and 3 months later

Cognitive and Affective Mechanisms Underlying an Olfactory Approach to Modify Cigarette Craving

The proposed study uses fMRI and behavioral measures in and outside the laboratory to investigate the neurobehavioral mechanisms underlying the impact of pleasant olfactory cues (OCs) on cigarette craving. The investigators plan to randomize 278 participants to a pleasant OC condition or an odor blank (neutral) condition and due to anticipated drop out expect to run 250 adult (half female) smokers, including both daily and nondaily smokers through the protocol. This study involves three visits. In the first visit, participants will complete a baseline breath carbon monoxide reading, a brief odor threshold test, and complete a series of self-report measures. In the next session, participants who are 8-hrs deprived of nicotine will undergo a 60-minute fMRI scan that will include structural, resting state, and task-based data collection. The fMRI task involves completing a series of tasks designed to index responses linked to key neural networks found to relate to addiction (e.g., reward processing, working memory). Participants will also be exposed to smoking cues to heighten craving and then depending on their condition (randomly assigned) will either receive a pleasant or neutral (odor blank) OC. In the third session, behavioral data will be collected to test the impact of either a pleasant or neutral OC on cigarette craving using self-reported urge and behavioral measures linked to craving. Finally, for pilot purposes designed to offer data for a subsequent clinical study (beyond this study), participants will additionally complete a 7-day ecological momentary assessment (EMA) protocol in which they will monitor cigarette craving and initial data will be collected outside the laboratory to evaluate the impact of OCs on naturally occurring craving. It is hypothesized that pleasant OCs will disrupt craving brain states and attenuate craving (as compared to neutral olfactory cues). Further, it is hypothesized that individual variation in neural responses to cognitive and affective tasks will reveal variation in mechanisms underlying pleasant OC craving reduction and that individual differences will moderate pleasant OC-induced craving relief. Finally, it is also expected that emotional responses to pleasant OCs will mediate the impact of OCs on craving and smoking-related processes.

Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

The proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. In addition to standard app-based self-monitoring of drug use and personalized feedback, project innovation is enhanced by the proposed use of location-tracking technology for targeted, personalized intervention when participants enter self-identified areas of high risk for relapse. Furthermore, the proposed sub-study would use longitudinal functional neuroimaging to elucidate the brain-cognition relationships underlying individual differences in treatment outcomes, offering broad significance for understanding and enhancing the efficacy of this and other app-based interventions.

Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder

The goal of this observational study is to investigate longitudinal stress response profiles and adaptive versus non-adaptive stress responses in alcohol use disorder. The main questions the projects aims to answer are: What are the neurobehavioral underpinnings of adaptive stress responses and resilience to repeated stress exposure with regards to: * alcohol craving? * alcohol use? * their modulation by prior stress exposure, social interactions, coping strategies and individual health behavior? Participants will: * be exposed to an established experimental stress-induction protocol, the Trier Social Stress Test * be exposed to their favorite drink in a bar lab environment * be assessed using fMRI to determine their neural alcohol cue reactivity, response inhibition, and emotion processing * conduct an ambulatory phase to assess stressors, alcohol craving, substance use and details on social interactions, health behavior and coping strategies using ecological momentary assessment tools.

Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption

In this research project, the aim is to discover the role specific brain networks play in the relationship between stress reactions and the desire for alcohol and alcohol consumption. To investigate this question, various brain imaging methods as well as cognitive tasks are combined. Various questionnaires are sampled and brain scans are conducted. Individuals interested in participating in the study have to fulfill certain criteria... * no serious medical or mental health diagnosis * problematic alcohol drinking habits * interested in improving drinking habits ...and undergo various non-invasive procedures * filling out several questionnaires concerning personality and habits * undergoing a mental performance task while being in a brain scanner (MRI) * attempting to regulate their own brain activity while lying in the MRI scanner * filling out an electronic diary for 6 weeks - concerning daily mood, stress, and alcohol habits Participants will be randomly allocated to either one of 2 experimental groups. Both groups undergo the same tasks, receive the same instructions and only differ regarding some aspects of the brain self-regulation task .