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NMDA Receptor Antagonist

Ketamine + Naltrexone for Alcoholism

Phase 1 & 2
Waitlist Available
Led By Gihyun Yoon, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21 (after 4th infusion, 240 minutes)
Awards & highlights

Study Summary

This trial will compare the safety and efficacy of ketamine plus naltrexone, ketamine alone, and placebo for treating comorbid major depressive disorder and alcohol use disorder.

Eligible Conditions
  • Depression
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21 (after 4th infusion, 240 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21 (after 4th infusion, 240 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Line Follow Back (TLFB)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketamine + PlaceboExperimental Treatment1 Intervention
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Group II: Ketamine + NaltrexoneExperimental Treatment1 Intervention
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular naltrexone once a month (a total of 2 injections).
Group III: Placebo (psychoactive placebo midazolam) + PlaceboPlacebo Group1 Intervention
Subjects in this arm will receive (1) intravenous placebo treatment (psychoactive placebo midazolam) once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine + Naltrexone
2016
Completed Phase 2
~70
Ketamine + Placebo
2015
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,364 Total Patients Enrolled
41 Trials studying Alcoholism
6,274 Patients Enrolled for Alcoholism
Gihyun Yoon, MDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
5 Previous Clinical Trials
342 Total Patients Enrolled
4 Trials studying Alcoholism
322 Patients Enrolled for Alcoholism

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02461927 — Phase 1 & 2
Alcoholism Research Study Groups: Ketamine + Placebo, Ketamine + Naltrexone, Placebo (psychoactive placebo midazolam) + Placebo
Alcoholism Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT02461927 — Phase 1 & 2
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02461927 — Phase 1 & 2
Alcoholism Patient Testimony for trial: Trial Name: NCT02461927 — Phase 1 & 2

Frequently Asked Questions

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

Are minors being included as participants in this experiment?

"Patients need to be at least 21 years in age and no older than 65 years old to qualify for this medical study."

Answered by AI

In what situations is Ketamine + Naltrexone traditionally used?

"Ketamine and Naltrexone can be combined to manage chronic weight issues, bolster physical activity levels, and reduce pain."

Answered by AI

Are there still vacancies available for participants in this experiment?

"As indicated on clinicaltrials.gov, this project is actively looking for participants. It was first published in January of 2015 and its details were revised as recently as June 14th 2022."

Answered by AI

How many participants are involved in this research?

"That is correct. Information retrieved from clinicaltrials.gov demonstrates that this trial, which was initially published on January 1st 2015, is currently seeking volunteers. Specifically, 65 participants are to be found at a single medical centre."

Answered by AI

Am I eligible to join the medical experiment?

"This trial is seeking 65 individuals between 21 and 65 who have major depressive disorder, a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or higher, as well as 4 out of 11 symptoms of an alcohol use disorder. Furthermore, applicants must prove they consume 5 drinks per day for men and 4 drinks per day for women on at least four occasions in the past month with written informed consent."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
California
Connecticut
How old are they?
18 - 65
What site did they apply to?
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0

Why did patients apply to this trial?

Because I need help and I want to make money as well. I have tried several antidepressants and they don’t work on me.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. VA Connecticut Healthcare System West Haven Campus, West Haven, CT: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
2015. "Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02461927.
~6 spots leftby Apr 2025
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