A Novel Compound for Alcoholism Treatment: A Translational Strategy - Part II

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 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. 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. Physical exams

Timeline

Start

2016-06-15

Primary completion

2020-02-20

Completion

2020-09-09

Outcome

Outcome not reported

Stopped: “Early termination of the study due to the COVID-19 pandemic”

Publications

• Tyler RE, Pfaff RK, Khan RMN, Loften A, Zurick R, Zeng Y, Arisa OT, Harvey C, Akhlaghi F, Figg WD, Farokhnia M, Leggio L. Pharmacokinetic and pharmacodynamic results from a randomized controlled study with the growth hormone secretagogue receptor blocker PF-5190457 in recently abstinent patients with alcohol use disorder. Int J Neuropsychopharmacol. 2026 Feb 2;29(2):pyaf081. doi: 10.1093/ijnp/pyaf081.
• Faulkner ML, Farokhnia M, Lee MR, Farinelli L, Browning BD, Abshire K, Daurio AM, Munjal V, Deschaine SL, Boukabara SR, Fortney C, Sherman G, Schwandt M, Akhlaghi F, Momenan R, Ross TJ, Persky S, Leggio L. A randomized, double-blind, placebo-controlled study of a GHSR blocker in people with alcohol use disorder. JCI Insight. 2024 Dec 20;9(24):e182331. doi: 10.1172/jci.insight.182331.

Drugs

Indications