Treatment for Alcohol Use Disorders (AUD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Connecticut Healtcase System, West Haven, CT
Alcohol Use Disorders (AUD)+1 More
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called allopregnanolone can reduce stress-induced craving and anxiety in people with alcohol dependence.

See full description

Eligible Conditions

  • Alcohol Use Disorders (AUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alcohol Use Disorders (AUD)

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 1 secondary outcome in patients with Alcohol Use Disorders (AUD). Measurement will happen over the course of 15 minutes.

15 minutes
Alcohol Urge Questionnaire (AUQ)
The State-Trait Anxiety Inventory (STAI-6)
30 minutes
Biphasic Alcohol Effects scale (BAES)

Trial Safety

Safety Progress

1 of 3

Other trials for Alcohol Use Disorders (AUD)

Trial Design

2 Treatment Groups

allopregnanolone
1 of 2
placebo
1 of 2
Active Control
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

allopregnanolone
Drug
allopregnanolone
placebo
Drug
placebo

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 minutes
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 minutes for reporting.

Who is running the study

Principal Investigator
E. R.
Elizabeth Ralevski, Research Scientist
Yale University

Closest Location

VA Connecticut Healtcase System - West Haven, CT

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Non-treatment seeking individuals with current DSM-5 AUD
No current substance use disorder (except tobacco, alcohol, and marijuana)
No current medical problems and normal ECG
For women, not pregnant as determined by pregnancy screening, not breast feeding.

Patient Q&A Section

What are the common side effects of treatment?

"Side effects of the various pharmacologic treatments for liver disease are common. These side effects, unlike those that have a more narrow biomedical basis, vary from mild to serious and may be debilitating." - Anonymous Online Contributor

Unverified Answer

Is treatment safe for people?

"It's clear that we are heading into a new era where health care professionals have to adopt new evidence-based approaches in order to help people stay inside the health system. There is ongoing need to build more confidence in health practitioners so that we are able to provide high quality treatment that is safe for the whole population." - Anonymous Online Contributor

Unverified Answer

What causes alcoholism?

"Alcoholism primarily is a disease, an acute-phase reaction, of the neuro-immune system. The acute-phase response can be influenced by genetics. Alcoholism is not caused by liver disease or the buildup of toxic products of the metabolism of alcohol. Alcoholism has multiple causes: genetics, brain, drugs like alcohol and tobacco chemicals, and also the social context. Alcoholism is not solely a disease of the brain." - Anonymous Online Contributor

Unverified Answer

How many people get alcoholism a year in the United States?

"Approximately 4.3 million Americans will become alcoholics by 2050. answer: The prevalence of alcoholism in the United States was as high a decade ago as today; however, the proportion of persons becoming alcoholics was much lower in the 1960s. These data provide a plausible explanation for the decline in alcohol-related mortality in the last two decades." - Anonymous Online Contributor

Unverified Answer

What are common treatments for alcoholism?

"A number of different treatments are used for alcoholism, including the following types of treatment: psychiatric medications, drug treatments, talk therapy with a professional or self-help organization, and exercise/aerobic exercise programs. There were some differences between male and female patients, with women patients being less likely to report being involved in alcoholics anonymous meetings. There appear to be no significant differences by ethnicity or by age of onset of alcoholism; however, there appear to be some differences among specific sub-populations." - Anonymous Online Contributor

Unverified Answer

Can alcoholism be cured?

"Although research on the topic is scarce and limited, some evidence indicates that heavy alcohol use can be effectively treated with psychodynamic methods. Further research on this technique is needed." - Anonymous Online Contributor

Unverified Answer

What are the signs of alcoholism?

"Alcoholism is a disease with many signs and symptoms that are related to its consequences. It can be very difficult to diagnose this disease because there are some signs similar to alcohol abuse / dependence that is observed by alcoholic patients. For example, the main signs of alcoholism are the alterations in the liver and a state of hypoalbuminemia. Also, alcoholism can cause malnutrition. To be in good condition, it is also necessary to eat a diet high in proteins." - Anonymous Online Contributor

Unverified Answer

What is alcoholism?

"Alcoholism involves a number of adverse physical and psychological effects including damage to the nervous system, brain and gastrointestinal tract. Alcohol is harmful in its own right and the combined effects of alcohol use and disease are often greater than the sum of those of either on their own.\n" - Anonymous Online Contributor

Unverified Answer

Does alcoholism run in families?

"As more alcoholism families are mapped, the chances to find a family member with alcoholism who is affected by alcohol-induced cancers will increase dramatically. As an example, the hereditary factors of alcoholism will hopefully be mapped before 2050." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for alcoholism?

"A significant majority (80%) of current alcoholic patients should be considered clinically evaluable for any clinical trial, and a sizeable minority (41%) may be of sufficient fitness for enrollment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of alcoholism?

"Drinking is a nonspecific response to many social stimuli and to nonspecific physical conditions. The main cause of alcoholism is that drinking is a nonspecific response to\nnonspecific social conditions. Alcoholism is a\npsychophysiological disorder, and the primary\ncause of alcoholism is that drinking is a\nnonspecific response\nto\nnonspecific psychological conditions. Alcoholic\nmasked to drink is a reaction to these\nconditions, which are external to the\nincline." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"Current research shows that treatment of alcoholism and opioid use disorders can be achieved through the use of a multifaceted approach using multimodal therapies. Further studies are required to determine whether all individuals identified in these programs will benefit from these interventions and to determine the most effective approaches." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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