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Manipulating Ghrelin Signaling Via GOAT Inhibition in Alcohol Use Disorder

NCT03896516 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-01-15

Study results available
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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.

Conditions

Interventions

OTHER

Placebo

Participants receive Placebo orally twice daily.

DRUG

GLWL-01

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Lorenzo Leggio, M.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2023-12-04
Completion
2023-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03896516 on ClinicalTrials.gov