Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01227980 · ClinicalTrials.gov registry record · Phase 2
Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT01227980 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 70 participants.
The verdict
NCT01227980, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
Background: \- Individuals who are dependent on alcohol often have feelings of anxiety, irritability, anger, and depression. These feelings, as well as stress, may contribute to the risk of relapse and continued drinking. Studies have shown that alcohol consumption increases the activity of certain molecules in the brain known as CRH1 receptors, which are key to producing the body s response to stress, and whose activation generates feelings of anxiety. Researchers are interested in learning whether the experimental drug pexacerfont, which blocks CRH1 receptors and has been studied in individuals with anxiety disorders and depression, can lessen anxiety and craving for alcohol as part of alcohol-dependence treatment. Objectives: \- To determine the safety and effectiveness of pexacerfont as a treatment for anxiety-related alcohol craving. Eligibility: \- Individuals between 21 and 65 years of age who are alcohol-dependent and have problems with anxiety. Design: * This study requires an inpatient admission to the NIH Clinical Center for approximately 1 month, with two additional study visits 1 week and 1 month after discharge from the hospital. * Participants will be screened with a medical history, physical examination, and blood and urine tests. * During the inpatient period, participants will have standard treatment for alcohol dependence, including support and interventions from institute staff to address cravings, anxiety, or other psychological problems. Participants will not receive formal psychological treatment or psychiatric medications for anxiety, but will receive training in relaxation techniques. * Participants will be assigned to take either pexacerfont or placebo for 3 weeks. During this time, participants will have the following procedures: * Frequent blood tests. * Rating scales and questionnaires about alcohol cravings and anxiety. * Dexamethasone suppression test with frequent blood draws to study hormone response to stress. * Social stress
Interventions
- DRUG Placebo
- DRUG Pexacerfont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01227980
The ClinicalTrials.gov registry entry for NCT01227980 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 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.
NCT01227980 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01227980 about?
NCT01227980 is a clinical study titled "Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^". Background: \- Individuals who are dependent on alcohol often have feelings of anxiety, irritability, anger, and depression. These feelings, as well as stress, may contribute to the risk of relapse and continued drinking. Studies have shown that alcohol consumption increases the activity of certain...
What is the current status of trial NCT01227980?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2010-10. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01227980?
The interventions under investigation include: Placebo (DRUG), Pexacerfont (DRUG).
Who is sponsoring clinical trial NCT01227980?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.