← Back to Search

NMDA Receptor Antagonist

Ketamine for Alcoholism

Phase 2

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted to BWF inpatient withdrawal management unit (Addiction Recovery Program)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once during treatment

Awards & highlights

Study Summary

This trial will study the safety and efficacy of using ketamine to treat alcohol use disorder in patients going through detox in the ED.

Who is the study for?

This trial is for English-speaking adults over 18 with severe alcohol use disorder (AUD), as diagnosed by DSM5 criteria. Participants must be able to provide two contacts post-hospital discharge and be admitted to the BWF inpatient withdrawal management unit.Check my eligibility

What is being tested?

The study tests if intravenous ketamine can help people with AUD seeking detoxification in the emergency department, compared to a saline placebo. It's a pilot study, meaning it's preliminary research that's double-blind (neither doctors nor patients know who gets what) and randomized.See study design

What are the potential side effects?

While specific side effects are not listed here, ketamine may commonly cause disorientation, dizziness, nausea, increased blood pressure or heart rate among others. The primary aim of this trial is to assess safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am admitted to the BWF inpatient withdrawal management unit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at 28 days after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at 28 days after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at 28 days after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of administering ketamine in the emergency department (ED) for alcohol use disorder (AUD) patients seeking detoxification

Secondary outcome measures

Alcohol withdrawal

Anxiety

Behavior Change Mechanisms

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: KetamineExperimental Treatment1 Intervention

This arm will receive ketamine (n=25)

Group II: PlaceboPlacebo Group1 Intervention

This arm will receive the saline placebo (n=25)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1090

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,898 Total Patients Enrolled

4 Trials studying Alcoholism

420 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,395 Total Patients Enrolled

424 Trials studying Alcoholism

985,818 Patients Enrolled for Alcoholism

Frequently Asked Questions

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

Are enrollment opportunities still available for individuals to join this trial?

"This clinical trial is still recruiting participants, based on the information available on clinicaltrials.gov. The advertisement for this study was posted in October 25th of 2023 and its details were last updated a month later, on December 4th."

Answered by AI

What are the possible adverse effects of utilizing Ketamine?

"Data regarding ketamine's safety has been assessed at a score of 2, as this Phase 2 trial does not yet include efficacy-supporting data."

Answered by AI

How many individuals are currently enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov illustrates that this clinical trial, which was first announced on October 25th 2023, is open for recruitment. The study requires 50 patients from a single medical facility to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketamine for the Treatment for Alcohol Use Disorder in the ED

Joji Suzuki, MD 2023. "Ketamine for the Treatment for Alcohol Use Disorder in the ED". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05661669.