Inpatient admission for Alcohol Drinking

Phase-Based Estimates
1
Effectiveness
1
Safety
New York State Psychiatric Institute, New York, NY
Alcohol Drinking+3 More
Inpatient admission - Behavioral
Eligibility
18 - 65
All Sexes
Eligible conditions
Alcohol Drinking

Study Summary

This study is evaluating whether a novel form of brain stimulation may help reduce alcohol consumption.

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Eligible Conditions

  • Alcohol Drinking
  • Disease
  • Alcoholism
  • Alcohol Use Disorders (AUD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Inpatient admission will improve 2 primary outcomes and 4 secondary outcomes in patients with Alcohol Drinking. Measurement will happen over the course of 4 weeks.

10 weeks
Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
4 weeks
Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).
Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).
Change in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session.
Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB).

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Sham Stimulation
Active Stimulation
Placebo group

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. Inpatient Admission 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 not being studied for commercial purposes.

Active StimulationParticipants will be receiving active rTMS.
Sham StimulationParticipants will be receiving sham stimulation with a smaller coil housed within the rTMS device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
active rTMS
2013
N/A
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 weeks for reporting.

Who is running the study

Principal Investigator
J. W.
Jonathan Wai, Addiction Psychiatry Clinical & Research Fellow
New York State Psychiatric Institute

Closest Location

New York State Psychiatric Institute - New York, NY

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Drinking at levels similar to those that will be studied in this program (1 drinking episode per week raising BAL to 0.03 g/dl - approximately 2 drinks within an hour). show original
They are physically healthy and do not have any current or past medical or neurological illnesses show original
Age 22-55
, is categorized as a Substance Use Disorder (SUD) An individual with a current moderate to severe alcohol use disorder is categorized as having a Substance Use Disorder (SUD). show original
The subject is able to understand the purpose of the study and give consent, and is able to comply with the study procedures. show original

Patient Q&A Section

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

How many people get alcohol drinking a year in the United States?

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About 2.5 million men drink alcohol a year in the United States. If one looks at the men drinking, then 21% are light drinkers. But if the men with light drinking were accounted for, the number of heavy drinkers declines.

Unverified Answer

What are common treatments for alcohol drinking?

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Alcohol drinking is commonly treated with counselling and medication, with no clear evidence of which of these are more effective. The evidence for the short-term or long-term benefits of CBT is unclear. Given the large amount of harm associated with alcohol, more studies are needed to establish the role of medications and counselling in alcohol drinking and the long-term outcomes to help individuals with harmful alcohol consumption.

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What is alcohol drinking?

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Alcohol consumption involves many components, with significant variation in consumption across countries and regions, and between socioeconomic groups within a country. In terms of health, alcohol consumption is typically associated with a wide range of adverse health effects, including an increased risk of chronic disease, alcohol-related deaths and injuries. The health and social burden of alcohol is substantial and requires further efforts to understand the complexities and risks associated with alcohol consumption, to identify the determinants of alcohol consumption and to prevent and reduce the adverse health effects associated with alcohol consumption. In recent years, alcohol consumption has fallen substantially worldwide, particularly among women; however alcohol consumption continues to be particularly high in low-and middle-income countries.

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What are the signs of alcohol drinking?

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Drinking can affect you in many ways. The earliest signs are typically short-term effects such as headaches, fatigue or the feeling of being unwell. These can then progress to long-term effects such as difficulty concentrating or having trouble making decisions due to blurred or disorientated vision and loss of judgment. Other early signs include feeling restless, dry mouth or difficulty swallowing. If a person drinks for long enough their tolerance becomes reduced and eventually it seems they are no longer able to drink at all. This is the point where the alcoholic has reached a point of losing control and is not able to stop any more. People can stop drinking if the severity of their alcoholic drinks become too much for the person, their family or their friends.

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Can alcohol drinking be cured?

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Alcohol is the most popular contributor to all cancers apart from lung cancer, which is largely unexplained by smoking and second-hand smoke, and which cannot be cured.

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What causes alcohol drinking?

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It is important to understand what causes alcoholic drinking rather than which group is more susceptible to getting alcoholism. It is important for healthcare workers and patients to understand that alcoholism is a disease and that, unlike many of the other [diseases] found in the population, it is not [correctable] by altering lifestyle habits.

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Is inpatient admission safe for people?

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Patients having a lower number of outpatient visits to the hospital on the index day of admission were not at increased risk of inpatient mortality. This could be a result of greater experience-based medical care for these patients with a high number of outpatient visits to the hospital.

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Have there been any new discoveries for treating alcohol drinking?

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None of the current drugs available for treating alcohol dependence has the capacity to restore the brain's normal ability to regulate the action of alcohol. (http://mcrf.org/publications/pubs/drinking_control.aspx). Although the number of clinical trials is still small, some have shown a great deal of promise, as have agents in clinical research for this purpose. As of 2018, researchers in this area still lack the means to determine with any reasonable accuracy which of these promising drugs may offer the best approach toward normalization of alcohol drinking. Future research will focus on optimizing current interventions and developing novel approaches to the treatment of alcohol dependence.

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What is the primary cause of alcohol drinking?

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Among those with alcohol use disorder, alcohol drinking is primarily a means of coping with negative mood states and not a pleasurable activity. As such, this may not be an effective management strategy in the context of alcohol treatment.

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What does inpatient admission usually treat?

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Alcohol and drug intake, the patient’s history and associated conditions and symptoms. Alcohol (not alcohol-related admission for poisoning) has a significant admissions rate (>70%) and may represent one of the most important causes of admissions during an acute hospital stay, the management of which can be challenging. In this series of patients admitted to the general hospital following admission for alcohol related injury, an alcohol dependency pattern of intake was uncommon.

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How serious can alcohol drinking be?

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It was found that the perceived seriousness of alcohol drinking was very different in each age category. It should be emphasized that moderate alcohol drinking is more common in each age group when compared to heavy or serious drinking.

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What is the latest research for alcohol drinking?

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The current research reveals that the amount of alcohol that people drink (in terms of volume) is not associated with an increased risk of cardiovascular, cerebrovascular, or other diseases. The majority of studies on alcohol and health have examined heavy drinkers (4 to 5 drinks/day). Data from a recent study of current research suggest that heavy drinking is not a serious public health issue.\n- Alcohol and health\n- Alcoholism"

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Get access to this novel treatment for Alcohol Drinking by sharing your contact details with the study coordinator.