A Novel Compound for Alcoholism Treatment: A Translational Strategy
Status:
Completed
Trial end date:
2020-09-09
Target enrollment:
Participant gender:
Summary
Background:
Hormones are naturally occurring chemicals in the body. Ghrelin is a hormone that stimulates
appetite. It may also stimulate alcohol cravings and use. Researchers want to learn more
about alcohol cravings and test if a drug that blocks ghrelin lowers alcohol cravings.
Objective:
To test if the drug PF-05190457 decreases alcohol craving.
Eligibility:
People ages 18-70 who have:
Alcohol use disorder
No other serious medical problems
Woman must be postmenopausal or have had surgery to prevent pregnancy.
Design:
Participants will stay on the inpatient unit here at the Clinical Center for two 2-week
stages, which will be separated by at least 2 days. The inpatient phase include:
Taking the study drug or placebo by mouth twice daily
Blood tests
Tasting several sweet solutions
Physical exams
Smokers will smoke cigarettes through a device that gives information about how they smoke a
cigarette.
Exposure to alcohol, water, and food cues in a bar-like room. Participants answer questions
on a computer.
Blood pressure and heart rate are monitored through an arm cuff and sensors on the chest.
Saliva is collected
through cotton rolls in the mouth.
MRIs: Participants lie on a table that slides in and out of the cylinder, and a coil is
placed over the head.
They complete tasks on a computer screen while in the cylinder. This lasts up to 2 hours.
Wearing a virtual reality headset, walking around a virtual room, and selecting virtual food
and drink.
Participants will have 8 hour long follow-up visits in our Outpatient Clinic These include:
Counseling to abstain from alcohol use. Sessions may be videotaped.
Physical exams
...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)