Clinical Research Directory

GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV

The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main questions it aims to answer are: 1. Does semaglutide lower the average number of alcoholic beverages participants drink per week? 2. Does semaglutide lower the average number of cigarettes participants smoke per day? 3. Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and/or smoke tobacco? Researchers will compare the effects of semaglutide to a placebo (a look-alike substance that contains no drug) to see if semaglutide works to lower the alcohol intake among participants each week. Participants will: 1. Take semaglutide for 3 months 2. Visit the research clinic 3 times for checkups and tests 3. Provide blood samples, stool samples, and saliva samples for tests.

Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments

The goal of this project is to evaluate the effectiveness of Safe Night Out, a community-level primary violence prevention program offered in drinking establishments in the Sacramento region of California. The main questions this project aims to answer are: 1) Does the Safe Night Out program reduce incidents of sexual violence and intimate partner violence among patrons? 2) Does the Safe Night Out program increase incidents of safety checks of patrons by staff participants? To address these questions, we will enroll 150 staff participants and 500 patron participants from 25 drinking establishments that have implemented the Safe Night Out program (\~3 staff participants and 10 patron participants per drinking establishment) and 25 drinking establishments that have not implemented the Safe Night Out program (\~3 staff participants and 10 patron participants per drinking establishment). Participants will complete a baseline and three 6-month follow-up assessments, until 18 month-follow-up.

Testing Alcohol Cancer Risk Messages

Testing gain vs loss-framed messages to address drinking among cancer survivors

Social Media Psychosocial Support Group in Reducing Alcohol Consumption

This proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, Ecological Momentary Assessment (EMA) and social media psychosocial support group to reduce alcohol consumption in women.

Tirzepatide for Alcohol Use Disorder

The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.

Piloting a Biomarker-augmented Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program Among HIV-affected Adolescents and Young Adults in Zambia

This will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (SBIRT) program conducted within existing HIV prevention and treatment services for adolescents and young adults (AYA) in Lusaka, Zambia. The screening component of the program will feature both a self-report and a urine biomarker (ethyl glucuronide; EtG) to evaluate recent alcohol use. We will recruit 60 AYA to participate in the pilot. The specific aims of this pilot are to: Specific aims: 1. Explore implementation factors of the SBIRT program within HIV prevention and treatment services through a process evaluation. We will quantitatively track the number of AYA in the SBIRT care cascade: 1) the number screened who have recent alcohol use; 2) the number of those with recent alcohol use who receive the brief intervention (BI); 3) the number of those who are referred for additional treatment; and 4) among those who are referred, the number who successfully link and complete treatment. We will collect time use data from clinic staff and counselors to estimate the time burden required for the SBIRT program. We will conduct 30 in-depth interviews with AYA three months after the screening. The sample will include adolescents who: (1) did not recently use alcohol; (2) received BI due to recent alcohol use that was low/moderate risk; and (3) were referred for treatment due to higher risk alcohol use. Interviews will focus on: (1) implementation factors (e.g., acceptability, feasibility) of the SBIRT program and (2) barriers and facilitators to the program's implementation. Focus group discussions and in-depth interviews will also be conducted with program staff (e.g., counselors, clinic staff) and other stakeholders (e.g., community leaders, policy-makers). 2. Evaluate the preliminary impact of the SBIRT program on AYA alcohol use. Among AYA who have recent alcohol use at screening, we will measure change in use at a three-month follow-up visit.

Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients

In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alcoholic hepatitis is different from that of a patient without alcoholic hepatitis. Acute alcoholic hepatitis has a severe prognosis and corticosteroids are the only first line therapy option, with better survival at 28 days versus placebo. However, mortality remains high at 30% at 3 months, which highlights the importance of seeking intestinal microbiota profile on treatment response. The determination of one or more intestinal microbiota signatures associated with the treatment response Corticosteroids plus FMT or Corticosteroids plus placebo will allow the clinician to have a simple and rapid test obtained in 16S RNA analysis to predict the therapeutic response and potentially the best treatment to adopt and to address medical and medico-economic stakes. The investigators will first characterize the alcohol-induced dysbiosis by a whole microbiota sequencing in the different groups. Specific bacterial species identify by DNA sequencing should be confirmed by qPCR of 16S rDNA to determine a fingerprint of sAH microbiota. Metabolic properties of intestinal microbiota, such as production of short chain fatty acids, will be analyzed by using HPLC. In the sAH group, evolution of intestinal microbiota will be observed by shotgun DNA sequencing between the day 0 and the day 7 of corticosteroids treatment. The analysis of sAH patients' microbiota (day 0) will allow us to obtain a non-responder profile to corticosteroids that can be used as a prognostic marker to use in the clinic. The deliverable is the bacterial fingerprint of the treatment response and its valuation is its use as a predictive tool of the response.

Rapid BAC Reduction with Nutraceutical Blend Study

Study Title: Nutritional Supplement to Rapidly Decrease Blood Alcohol Concentration (BAC): Safety and Efficacy Study Design: Double-blind, randomized, placebo-controlled clinical trial Objective: Evaluate safety and efficacy of a nutritional supplement to rapidly decrease blood alcohol concentration (BAC), alcohol-induced impairment, and hangover symptoms after excessive alcohol consumption. Primary Outcomes: BAC reduction rate/extent (BACtrack S80™ breathalyzer) Cognitive/physical impairment change (DRUID app™) Secondary Outcome: Hangover symptom reduction (Acute Hangover Scale) Participants: 35 participants, recruited via social media Duration: 2 weeks, 2 testing sessions (4 hours each) Location: Closed facility in St. Petersburg, FL Procedure: Subjects consume standardized alcohol (1g ethanol/kg body weight) 40-minute drinking period BAC and impairment measurements Administration of test formulation or placebo Measurements: BAC: Baseline, 40min, 15min, 30min, 60min, 90min post-drinking Impairment: Baseline, 15min, 30min, 60min post-drinking Hangover: Next morning via text message Safety Measures: GRAS ingredients Lab testing of formulations Medical screening Adverse effect questionnaires Pregnancy tests BAC \<0.08% before leaving Key Features: Paired measurements: active vs. placebo for mini-drink and capsule formulations Uber transportation provided Strict inclusion/exclusion criteria Data Analysis: Electronic data entry Blinded submission for statistical analysis Paired comparisons and multiple statistical tests This study aims to provide robust data on the efficacy in mitigating alcohol's effects, potentially offering a new tool for reducing alcohol-related impairment and hangover symptoms. The design prioritizes safety, consistency, and scientific rigor to ensure reliable results.

A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers

The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol. Participants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.