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NCT01187511 · ClinicalTrials.gov registry record · Phase 2
CRF1 Antagonist GSK561679 in Alcoholism
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT01187511 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 44 participants.
The verdict
NCT01187511, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Objective: To evaluate GSK561679, an orally available, brain penetrant selective CRH1 antagonist for its ability to reduce alcohol craving in recently detoxified alcohol dependent women in response to stress or alcohol-associated stimuli. Study population: Up to 60 anxious, alcohol dependent women, aged 21-65 years will be enrolled to complete the study in 50 patients. Background: * Anxiety, irritability, anger, and depression can all cause stress that may lead to continued drinking in heavy drinkers. One way the brain responds to stress is through a protein on brain cells called a CRH receptor. Previous research has shown that the CRH receptor is involved in negative emotional states and that chronic alcohol consumption increases the activity of CRH receptors in the brain. Medications that block CRH receptors can decrease stress-triggered alcohol consumption. * GSK561679, an experimental drug that blocks the CRH receptors, can reduce negative emotions such as anxiety and a person s desire for alcohol. By looking at the brain s response to stress and the study drug using functional magnetic resonance imaging (fMRI) scans, researchers hope to learn whether GSK561679 can be an effective treatment for stress-related alcohol abuse. Objectives: \- To evaluate the usefulness of GSK561679 in reducing stress-related alcohol craving in alcohol-dependent women. Design: * Participants in the study will be enrolled in the standard NIH treatment program for alcohol dependence, and will be required to stay at the NIH inpatient treatment unit for an additional 31 days. * Participants will receive either the study medication or a placebo to be taken once a day in the evening for 4 weeks. * Participants will have the following procedures while on the study medication: * Questionnaires about alcohol craving, depression, and anxiety. * Recordings and responses to personal emotional reactions to stressful, nonstressful, and alcohol-related situations, with blood samples taken
Interventions
- DRUG Placebo
- DRUG GSK561679
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-01 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01187511
The ClinicalTrials.gov registry entry for NCT01187511 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 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 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01187511 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01187511 about?
NCT01187511 is a clinical study titled "CRF1 Antagonist GSK561679 in Alcoholism". Objective: To evaluate GSK561679, an orally available, brain penetrant selective CRH1 antagonist for its ability to reduce alcohol craving in recently detoxified alcohol dependent women in response to stress or alcohol-associated stimuli. Study population: Up to 60 anxious, alcohol dependent wome...
What is the current status of trial NCT01187511?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2010-01. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01187511?
The interventions under investigation include: Placebo (DRUG), GSK561679 (DRUG).
Who is sponsoring clinical trial NCT01187511?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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