CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
GLWL-01 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03896516
NCT03896516Phase 2Completed

Manipulating Ghrelin Signaling Via GOAT Inhibition in Alcohol Use Disorder

National Institute on Drug Abuse (NIDA)·interventional·Posted Apr 1, 2019·Updated Jan 15, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo and GLWL-01 for Alcohol Use Disorder. Completed, enrolled 21 participants across 1 site.

Detailed Summary

Background: People with alcohol use disorder (AUD) have trouble controlling their drinking. Medications can help some people with AUD but are not effective for many others. Researchers want to test new drugs to better treat the disease. Objective: To see if the investigational drug GLWL-01 is safe to use in people with alcohol problems. Also, to find out if the drug reduces the urge to drink alcohol. Eligibility: People ages 18-70 with Alcohol Use Disorder (AUD) Design: Participants will be screened under protocol 06-DA-N415. Participants will be admitted to the inpatient facility, Clinical Research Unit (CRU) on the Johns Hopkins Bayview Medical Center for up to 21 days. They may leave the CRU on specified days pending approval. All their meals will be provided. They cannot drink alcohol. Participants will take either the study drug or a placebo by mouth twice daily. They will not know which they are receiving. Participants will complete many questionnaires. Participants may have urine tests. Participants will complete tasks on a computer. Participants will have blood samples obtained on some study days. Participants will taste and indicate their preference for sweet liquids. Participants' blood pressure, pulse, respiratory rate, body temperature and weight, heart rate and rhythm will be measured. Participants will have breath testing to obtain information about smoking. Participants will be exposed to alcohol cues, water, and food cues in a bar-like room. Cues are things that might make them feel the urge to eat or drink alcohol. Participants will take part in a virtual buffet experiment - They will wear a virtual reality headset, walk around a virtual room, and select virtual food and drink.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartJun 22, 2021
Primary CompletionDec 4, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.3 years ago

Interventions

Placeboother

Participants receive Placebo orally twice daily.

GLWL-01drug

GLWL-01 is a ghrelin O-acyltransferase (GOAT) inhibitor. Participants receive GLWL-01 orally twice daily.