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NCT02039349 · ClinicalTrials.gov registry record · Phase 1
A Novel Compound for Alcoholism Treatment
A Phase 1 study of Alcohol Drinking and Alcoholism, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02039349: Completed Phase 1 study of Alcohol Drinking and Alcoholism, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT02039349 is a Phase 1 study of Alcohol Drinking and Alcoholism that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 14 participants, below the 630-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02039349, a Phase 1 study of Alcohol Drinking and Alcoholism, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
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 |
What the finished NCT02039349 record still lists
NCT02039349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 630-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (98% lower).
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.
NCT02039349 reports a single indexed study location in Maryland.
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.
What interventions are being tested in trial NCT02039349?
The interventions under investigation include: PF-05190457 (DRUG).
Who is sponsoring clinical trial NCT02039349?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Alcohol Drinking
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02039349's enrollment target sits among peer trials
14 81st of 85 higher than 5 of 85 other Alcohol Drinking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Drinking trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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