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NCT00923923 · ClinicalTrials.gov registry record · NA
Stress Reactivity in Veterans Receiving Pharmacological Treatment for PTSD and Alcohol Dependence
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT00923923 is a NA study that has completed, run by Yale University. The registered enrollment target is 57 participants.
The verdict
NCT00923923, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study Summary
Method: This study is designed as an accompaniment to an already funded study - a 12-week treatment trial with prazosin for patients with PTSD and AD. The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to stress. Stress reactivity will be measured using: traumatic experiences, stressful non-trauma experiences and neutral experiences, presented randomly. Laboratory sessions will be conducted in an outpatient setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12 weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III, subjects will again participate in a laboratory session. This phase of the study will be conducted after at least 6 weeks of treatment while patients are on medication (prazosin or placebo). Hypotheses: Primary: The investigators hypothesize that prazosin will be more effective than placebo in reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety, craving for alcohol, and hormonal response, in individuals with PTSD and AD. Secondary: The investigators hypothesize that stress reactivity will have a moderating effect on treatment with prazosin, such that individuals with high levels of stress reactivity will have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to relapse than individuals with low levels of stress reactivity.
Interventions
- BEHAVIORAL stress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2009-01 |
| Est. Completion | 2015-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923923
The ClinicalTrials.gov registry entry for NCT00923923 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which stress is the first listed.
NCT00923923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923923 about?
NCT00923923 is a clinical study titled "Stress Reactivity in Veterans Receiving Pharmacological Treatment for PTSD and Alcohol Dependence". Method: This study is designed as an accompaniment to an already funded study - a 12-week treatment trial with prazosin for patients with PTSD and AD. The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to...
What is the current status of trial NCT00923923?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2009-01. Estimated completion is 2015-07.
What interventions are being tested in trial NCT00923923?
The interventions under investigation include: stress (BEHAVIORAL).
Who is sponsoring clinical trial NCT00923923?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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