CRF1 Antagonist GSK561679 in Alcoholism
Public ClinicalTrials.gov record NCT01187511. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effects of Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism on Stress-Induced Craving in Alcoholic Women With High Anxiety: an Experimental Medicine Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 during the responses. * Regular blood tests to measure stress hormones in the blood. * Speech preparation and presentation (Trier test), along with blood samples, to measure stress hormones in the blood. * Sessions to measure responses to alcohol-related cues. * Functional magnetic resonance imaging (fMRI) scans. * Participants will return for follow-up visits 1 week and 1 month after stopping the study drug and being discharged from the study.
Study identification
- NCT ID
- NCT01187511
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 44 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 65 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2009
- Primary completion
- Aug 31, 2015
- Completion
- Aug 31, 2015
- Last update posted
- Nov 6, 2016
2010 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01187511, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2016 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01187511 live on ClinicalTrials.gov.