Treatment Trials

8 Clinical Trials for Various Conditions

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RECRUITING
Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care
Description

This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Participants screening positive in VA primary care for hazardous drinking and posttraumatic stress disorders (PTSD) and/or depression in the past year will be recruited. Participants will be randomly assigned to one of two study conditions - SLAC plus usual care or usual care only. The investigators will determine the feasibility of conducting a larger scale study to evaluate SLAC in primary care and SLAC's acceptability among key stakeholders (e.g., Veterans, primary care providers). Other outcomes will include exploring whether SLAC improves linkage to an alcohol care or help option and/or reduces alcohol use and mental health (PTSD, depression) symptoms.

COMPLETED
SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers
Description

The purpose of this study is to examine the implementation of two evidence-based intervention strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug use, and HIV risk behaviors.

RECRUITING
Digoxin In Treatment of Alcohol Associated Hepatitis
Description

Prospective, single center, open label, randomized controlled trial to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients with acute alcohol associated hepatitis, digoxin administration and dose adjustment. The study intervention will be intravenous digoxin (renal-based dosing for maximum of 28 days) versus no digoxin in an open-label 1:1 randomized allocation of patients with severe acute alcohol associated hepatitis.

ENROLLING_BY_INVITATION
Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation
Description

The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.

COMPLETED
Naltrexone for Heavy Drinking in Young Adults
Description

In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo.

COMPLETED
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
Description

This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.

COMPLETED
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Description

The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

COMPLETED
Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder
Description

In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2 weeks but no more than 6 months) from Alcohol Use Disorder (AUDIT-C score \>4) and are experiencing sleep problems (ISI score \>/= 10). 64 of these individuals will be randomly allocated to receive the full HealthRhythms package (sensing, trending, and stabilization) on their smartphones, while 64 will be asked to consent to sensing only. The duration of the study will be 14 weeks. The primary outcome measures of the RCT will be the ISI (Insomnia Severity Index). The investigators hypothesize that those receiving the full package will demonstrate lower levels of sleep disturbance.