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NCT00896038 · ClinicalTrials.gov registry record · Phase 2
The Effect of NK1R Antagonism on Alcohol Craving and PTSD Symptoms in Alcohol Dependent Patients With PTSD
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT00896038 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 58 participants.
The verdict
NCT00896038, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Objective: Alcoholism is highly co-morbid with post traumatic stress disorder (PTSD). Since stress and negative affective states are major relapse triggering factors for alcohol use, the negative symptoms associated with PTSD are thought to promote alcohol dependence. Substance P, which is released in the amygdala in response to stress, acts at NK1 receptors (NK1Rs) to mediate behavioral stress responses. Blockade of the NK1R represents a novel approach for anti-stress actions. In a recent double blind, placebo controlled study involving detoxified anxious alcoholics, we found that NK1R antagonism decreased alcohol cravings, attenuated cortisol response to stress, and significantly decreased insula activation in response to negative sensory input. The present study is intended to expand the findings and determine whether the NK1R is a candidate target for treating alcohol dependent patients with PTSD. Study Population: On hundred twenty participants with PTSD and co-morbid alcohol dependence will be recruited and stratified by PTSD etiology (60 participants each with civilian and combat PTSD, resp). Within each stratum, the treatment groups will be balanced for sex using urn randomization. Stratification is indicated since civilian and combat-related PTSD can theoretically have a different pathophysiology. Civilians typically experience a single trauma exposure of invariably high magnitude, resulting in symptoms immediately. Combat-related PTSD typically results from multiple traumatic exposures over a prolonged period of time, of variable magnitude, and frequently with delayed emergence of symptoms. Design: Participants will be admitted to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) research inpatient unit at the NIH Clinical Research Center (CRC) under protocol number 05-AA-0121 for assessment and treatment of people with alcohol drinking problems, which provides diagnostic assessments and standard withdrawal treatment if needed. Participan
Interventions
- DRUG Placebo
- DRUG Aprepitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2009-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00896038
The ClinicalTrials.gov registry entry for NCT00896038 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 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.
NCT00896038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00896038 about?
NCT00896038 is a clinical study titled "The Effect of NK1R Antagonism on Alcohol Craving and PTSD Symptoms in Alcohol Dependent Patients With PTSD". Objective: Alcoholism is highly co-morbid with post traumatic stress disorder (PTSD). Since stress and negative affective states are major relapse triggering factors for alcohol use, the negative symptoms associated with PTSD are thought to promote alcohol dependence. Substance P, which is released...
What is the current status of trial NCT00896038?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2009-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00896038?
The interventions under investigation include: Placebo (DRUG), Aprepitant (DRUG).
Who is sponsoring clinical trial NCT00896038?
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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