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Opioid Antagonist
Naltrexone for Alcoholism
Phase 4
Waitlist Available
Led By David Hui, MD
Research Sponsored by Albert Einstein Healthcare Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial is proposing a way to connect patients who come to the emergency room with alcohol use disorder to outpatient care in order to try and decrease problematic drinking.
Who is the study for?
This trial is for adults over 18 who show up at the emergency department with alcohol-related issues, want to cut down or stop drinking, and have an AUDIT score of 16 or higher. It's not for those with severe liver disease, allergies to naltrexone, pregnant women, prisoners, non-English speakers without contact means, opioid users, or anyone unable to consent.Check my eligibility
What is being tested?
The study tests if starting oral naltrexone in the emergency department can help link patients with alcohol use disorder to outpatient therapy. Success will be measured by how many follow-up for Vivitrol injections at a community center and continue treatment.See study design
What are the potential side effects?
Naltrexone may cause nausea, headache, dizziness or fatigue. Since it affects how the body responds to alcohol and opioids, it could also lead to withdrawal symptoms in people dependent on these substances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful referral and follow-up in MAT clinic
Secondary outcome measures
Alcohol use severity measures
Side effects data
From 2019 Phase 2 trial • 29 Patients • NCT030085907%
Dizziness
3%
Ankle injury
3%
Infections, minor viral or bacterial
3%
Fatigue
3%
Lip and tongue swelling
3%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
During Placebo Treatment
During Naltrexone Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: ParticipantExperimental Treatment1 Intervention
All participants who meet inclusion criteria will be offered oral naltrexone in the ED, a bridge prescription for oral naltrexone, and be referred to outpatient MAT clinic where participants will be offered monthly IM naltrexone injections.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved
Find a Location
Who is running the clinical trial?
Albert Einstein Healthcare NetworkLead Sponsor
64 Previous Clinical Trials
868,692 Total Patients Enrolled
David Hui, MDPrincipal InvestigatorAlbert Einstein Medical Center
16 Previous Clinical Trials
101,520 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I want to cut down or stop drinking alcohol.I will be admitted to the hospital.My liver is not working properly.I do not speak English.I am unable to give my consent.
Research Study Groups:
This trial has the following groups:- Group 1: Participant
Awards:
This trial has 5 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers being recruited for this experiment currently?
"This clinical trial is not currently recruiting individuals, as per the listing on clinicaltrials.gov which was last updated in January of this year. However, there are 268 other medical studies that are actively seeking applicants at present time."
Answered by AI
Is Naltrexone Pill a viable option for individuals seeking to optimize their safety?
"The safety of Naltrexone Pill is assessed as a 3 since it has completed Phase 4 trials, which implies the medication has been approved."
Answered by AI
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