MedTrace Logo

A Novel Compound for Alcoholism Treatment

NCT02039349 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-12-16

No results posted yet for this study

Summary

Background:

\- Hormones are naturally occurring chemicals in your body. Ghrelin is a hormone that is mainly produced by the stomach and stimulates appetite. Some studies suggest it may stimulate alcohol craving and use. Drugs have been developed that block ghrelin. Researchers want to know if people can tolerate a particular drug that blocks ghrelin. It will be given at two dose levels, combined with alcohol.

Objective:

\- To determine if a drug that may decrease alcohol consumption when given along with alcohol is safe and tolerable.

Eligibility:

* Healthy adults 21-65 years old who have 14 (women) to 21 (men) drinks a week.
* No one of childbearing potential can participate.

Design:

* Participants will have 3 inpatient clinic visits; each will last 4 days.
* They will have physical exam and blood and urine tests.
* They will have breath tests for alcohol and smoking.
* They will answer health and mood questions.
* Researchers will measure their reaction to smelling alcohol and tasting a sweet drink.
* They will eat only the food provided by the clinic. They will keep a food diary 1 day before each stay.
* They will be randomly assigned to take the study drug or placebo 5 times each stay.
* On Day 3, they will drink alcohol after taking the drug. They will give many blood samples that day through a tube inserted in their skin.
* Smokers can take smoke breaks. Once, they will smoke a cigarette through a device.
* One week after the last stay, participants will have a follow-up visit to answer questions.

Conditions

  • Alcoholism
  • Alcohol-Related Disorders
  • Alcohol Dependence
  • Alcohol Drinking Related Problems
  • Alcohol Drinking

Interventions

DRUG

PF-05190457

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • University of Rhode Island

    collaborator OTHER

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Lorenzo Leggio, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-03
Primary Completion
2015-10-01
Completion
2017-12-24

Countries

  • United States

Study Locations

More Related Trials

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 NCT02039349 on ClinicalTrials.gov