Manipulating Ghrelin Signaling Via GOAT Inhibition in Alcohol Use Disorder
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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....
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute on Drug Abuse (NIDA)