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A Novel Compound for Alcoholism Treatment
NCT02039349 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG PF-05190457
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-01-03 |
| Est. Completion | 2017-12-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02039349
The ClinicalTrials.gov registry entry for NCT02039349 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Alcohol Drinking appearing as the primary indexed condition, and to 1 intervention — of which PF-05190457 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02039349 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02039349 about?
NCT02039349 is a clinical study titled "A Novel Compound for Alcoholism Treatment". 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 peopl...
What is the current status of trial NCT02039349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2014-01-03. Estimated completion is 2017-12-24.
What conditions does trial NCT02039349 study?
This clinical trial studies the following conditions: Alcohol Drinking, Alcoholism, Alcohol Dependence, Alcohol-Related Disorders, Alcohol Drinking Related Problems. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02039349?
The interventions under investigation include: PF-05190457 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02039349?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02039349 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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