Treatment Trials

9 Clinical Trials for Various Conditions

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COMPLETED
Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia
Description

This is a randomized controlled trial (RCT) evaluating the effectiveness of a screening, brief intervention, and referral to treatment (SBIRT) stepped-care system in reducing unhealthy AOD use among Congolese refugees and the host community in Mantapala, an integrated settlement in northern Zambia.

COMPLETED
Women SHARE Study: Reducing Sexual Risk
Description

This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).

SUSPENDED
Amplification of Positivity for Alcohol Use Disorder Co-Occurring With Anxiety or Depression
Description

The purpose of this study is to examine the feasibility of a protocol in which individuals with comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete Amplification of Positivity for Alcohol Use Disorder (AMP-A)- a psychological treatment focused on increasing positive thoughts, emotions, and behaviors- or a traditional cognitive-behavioral therapy (CBT) intervention. Assessed outcomes will include participant acceptability and completion rates, participant compliance with the intervention, positive and negative affect, substance use- and depression and anxiety-related symptom severity, and functional disability.

COMPLETED
Neuroimmune Dysfunction in Alcohol Use Disorder
Description

The objective of this proposal is to advance medication development for alcohol use disorder by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator, as a potential treatment. This study has important clinical implications, as the available treatments for alcohol use disorder are only modestly effective and testing novel medications is a high research priority.

COMPLETED
Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users
Description

Our primary aim is to assess the feasibility of initiating treatment in the ED with extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and continuing care in cooperation with clinic providers as well as how best to assess outcomes. Secondarily, the investigators will explore its effect on various health outcomes (healthcare utilization and engagement, expenditures, drinking and consequences, quality of life) as well as the association of patient-level characteristics (e.g. sex, race, baseline drinking, health and psychosocial factors, mu opioid receptor genotype) with effectiveness. Determining both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase 1) is essential before planning a large-scale effectiveness trial (phase 2).

COMPLETED
Mifepristone Treatment of Alcohol Use Disorder
Description

This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.

WITHDRAWN
Effect of JNJ 31001074 on Urge to Drink in Alcohol-Dependent Adults
Description

The purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the urge to drink alcohol in alcohol-dependent study participants who are not seeking treatment.

Conditions
COMPLETED
Study of Structural Imaging
Description

Background: The way alcohol affects brain structure has been widely studied. But the way it affects all parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI) scans to study brain structure and function. They hope this will help them better understand changes that happen in brain regions during treatment of alcohol use disorders. Objectives: To study changes in the brain by using MRI in people with and without alcohol use disorders. To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how the brain recovers when alcohol use stops. Eligibility: People with alcohol dependence who are currently hospitalized in a particular unit at NIH. Healthy volunteers 30 60 years old without an alcohol use disorder. Design: Participants will be screened under a separate protocol. Participants will give a urine sample for a drug test and pregnancy test at each study visit. They will also have to pass a breath alcohol test. At the first visit, participants will have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. They will do behavior and memory tasks outside the scanner. They will have gait and balance tested. They will have to stand on both legs, stand on just one leg, and walk in a straight line. They will perform each task with eyes open, then with eyes closed. They will have tests of memory, thinking, and problem solving. Some participants will have a second visit. They will have another MRI and repeat some of the behavior and memory tasks. ...

NOT_YET_RECRUITING
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
Description

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.