Clinical Trial: A Novel Compound for Alcoholism Treatment: A Translational Strategy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Novel Compound for Alcoholism Treatment: a Translational Strategy - Part II
Brief 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 65 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 m
Detailed Summary:
Objective:
Ghrelin is a 28-amino acid peptide that stimulates appetite and food intake. It is an endogenous ligand for the growth hormone secretagogue receptor (GHSR1a). Preclinical studies suggest that ghrelin modulates alcohol reward processing. Previous work from our research team, indicated that intravenous (IV) ghrelin administration, compared to placebo, results in an acute increase in alcohol craving during a cue-reactivity experiment in alcoholic individuals. Therefore, an oral bioavailable, ghrelin receptor antagonist that is able to pass through the blood brain barrier holds particular promise as a treatment for alcohol use disorder (AUD). This protocol is part of a grant project funded by National Center for Advancing Translational Sciences (NCATS) aimed to generate preliminary evidence in AUD on the safety and efficacy of a ghrelin receptor (GHSR1a) antagonist, PF-05190457, an existing molecule available under the NIH-Industry Pilot Program at NCATS. Completed preclinical and clinical (Protocol #14-AA-0042) work has demonstrated the safety of PF-05190457/alcohol interaction. The goal of this protocol is to conduct a proof-of-concept human laboratory study to assess an early-signal of efficacy of PF-05190457 in AUD.
Study population:
The study population will be AUD individuals (n = 55).
Study Design:
A within-subject, counterbalanced, double-blind, placebo-controlled study.
Outcome measures:
The primary aim will be to determine whether PF-05190457, compared to placebo, reduces alcohol cue-elicited craving. The main secondary aim will be to determine whether PF-05190
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Current Primary Outcome: The primary aim will be to determine whether PF-05190457, compared to placebo, reduces alcohol cue-elicited craving. [ Time Frame: During CR procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To determine whether PF-05190457, compared to placebo, reduces brain blood oxygen level dependent (BOLD) response during exposure to alcohol cues [ Time Frame: During the approximately 2 hour task-based fMRI ]
- To determine whether PF-05190457, compared to placebo, reduces food choices in a virtual buffet conducted in a virtual reality context [ Time Frame: During the approximately 1 hour IVETU session ]
Original Secondary Outcome: Same as current
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: March 11, 2016
Date Started: March 2, 2016
Date Completion: December 31, 2018
Last Updated: April 20, 2017
Last Verified: March 9, 2017
