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Enzyme Inhibitor
GLWL-01 for Alcohol Use Disorder
Phase 1 & 2
Waitlist Available
Led By Lorenzo Leggio, M.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female individuals 18-70 years old (inclusive)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-year
Awards & highlights
Study Summary
This trial is testing whether the drug GLWL-01 is safe and effective in people with alcohol problems.
Who is the study for?
Adults aged 18-70 with Alcohol Use Disorder who can communicate in English and have a negative drug test for certain substances. Women must not be pregnant and agree to use effective contraception; men must also commit to reliable birth control methods. Excludes those with significant liver, kidney, heart issues, or unstable medical conditions.Check my eligibility
What is being tested?
The trial is testing GLWL-01's safety and its effect on reducing the desire to drink alcohol in people with AUD. Participants will stay at an inpatient facility for up to 21 days, take the study drug or placebo twice daily without knowing which one they receive, and undergo various tests including questionnaires and blood samples.See study design
What are the potential side effects?
While specific side effects of GLWL-01 are not listed here, participants will be closely monitored for any adverse reactions during their stay at the clinical research unit through regular health checks such as blood pressure measurements and heart rate monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The co-primary aims will be 1) AE's and alcohol craving
Secondary outcome measures
The effects of GLWL-01 on food choices using a virtual buffet experimental procedure. We will also monitor a wide range of behavioral measures including e.g., pain, anxiety, depression, alcohol craving, withdrawal, smoking
Side effects data
From 2019 Phase 2 trial • 19 Patients • NCT0327485616%
Diarrhoea
16%
Headache
11%
Viral upper respiratory tract infection
5%
Rhinorrhoea
5%
Faeces soft
5%
Faeces discoloured
5%
Menstruation delayed
5%
Throat irritation
5%
Amenorrhoea
5%
Constipation
5%
Nail infection
5%
Upper respiratory tract infection
5%
Agitation
5%
Dyspepsia
5%
Menstruation irregular
5%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
GLWL
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active DrugExperimental Treatment1 Intervention
GOAT Inhibitor
Group II: PlaceboPlacebo Group2 Interventions
Placebo Participants will take GLWL-01 450 mg b.i.d. or matched placebo for up to 16 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLWL-01
2019
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)Lead Sponsor
2,470 Previous Clinical Trials
2,619,721 Total Patients Enrolled
48 Trials studying Alcoholism
28,393 Patients Enrolled for Alcoholism
Lorenzo Leggio, M.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
10 Previous Clinical Trials
9,414 Total Patients Enrolled
8 Trials studying Alcoholism
263 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had weight loss surgery in the past.I have diabetes and am taking medication for it.I haven't taken any drugs that strongly affect liver enzymes or St. John's Wort in the last 28 days.I am a woman who cannot become pregnant due to age or medical reasons.I have not taken weight loss medications in the last 30 days.I can avoid taking certain medications and grapefruit for 14 days before starting the study medication.I've been on medication that affects my heart's rhythm for over 3 months with a safe QTcF level.I am between 18 and 70 years old.My BMI is under 18.5 and I weigh less than 60 kg.I agree to use effective birth control or remain abstinent during and for 3 months after the study.My family has a history of Long QT Syndrome.I am using effective birth control and have a negative pregnancy test.I do not have significant eating, pituitary, adrenal gland, or stomach movement disorders.I am not pregnant, will use effective birth control, or am not of child-bearing potential.My thyroid disorder is stable with my current FDA-approved medication.I am currently taking a specific dose of simvastatin, atorvastatin, or lovastatin.I have taken benzodiazepines for alcohol detox but will wait the required time before starting the study drug.I have a history of severe motion sickness or balance disorders.I have a history of epilepsy or seizures.I agree to use effective birth control or remain abstinent during and for 3 months after the study.I have been diagnosed with liver cirrhosis.You have a problem with alcohol, as determined by a diagnostic tool that asks about your symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Active Drug
Awards:
This trial has 0 awards, including: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 patient applications currently being accepted for this experiment?
"Yes, the trial is still ongoing and actively looking for participants. It was first posted on June 22nd, 2021 and updated September 29th, 2022. The research team wants to enroll 43 individuals at a single site."
Answered by AI
Do the inclusion criteria for this research extend to octogenarians?
"The patients who meet the age requirements of 18-70 years old are able to participate in this trial. However, there are 34 other studies for those under 18 and 254 for seniors that might be a better match."
Answered by AI
How can I qualify to participate in this research study?
"This study is looking for 43 patients of either gender, aged 18 to 70, who have a history of alcohol abuse. In addition to this broad inclusion criteria, participants must also: - Be able to communicate and understand English- Have negative urine drug tests for common substances - Score less than 8 on the CIWA-Ar test - Agree to use contraception during the study if they are of childbearing age and not pregnant"
Answered by AI
How many people are enrolled in this research project?
"Yes, the information available on clinicaltrials.gov suggests that this trial is open and looking for patients who match its inclusion criteria. This particular study was first posted on June 22nd, 2021 and was last updated on September 29th, 2022. 43 individuals are needed to complete the study at 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
National Institute on Drug Abuse
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
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