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NCT00430690 · ClinicalTrials.gov registry record
Acoustic Startle Reduction In Cocaine Dependence
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 144
- Enrollment target
NCT00430690: Completed study, sponsored by Emory University.
NCT00430690 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 144 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00430690 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 144 participants
- Enrollment target
Study Summary
Chronic cocaine administration leads to changes in brain function that persist long after the acute withdrawal phase. The acoustic startle response (ASR) is a well characterized reflexive response to a sudden acoustic stimulus. The ASR is mediated by a simple 3-synapse subcortical circuit; it is modulated in part by brain areas and neurotransmitters associated with cocaine administration. Our initial study and subsequent replication reveals a profound diminution of the ASR in cocaine-dependent subjects after a brief period of abstinence. Our preliminary findings indicate that first degree relatives of cocaine-dependent subjects also have reduced startle compared to healthy controls. The findings of low ASR in rats and humans during cocaine washout and low ASR in family members suggests there may be both a trait and state component of the startle reductions we have reported. The central objectives of this proposal are to dissect this finding with regard to its development and persistence in early and later phases of cocaine abstinence in humans; to ascertain whether startle reduction and its potential normalization during later abstinence is a predictor of clinical course in human subjects with cocaine dependence; and to examine whether startle reduction is, at least in part, a vulnerability trait for the development of cocaine dependence. This latter Aim will be carried out in humans by testing siblings of cocaine-dependent subjects. Cocaine dependence is an enormous public health problem. The significance of this work lies in the potential for the ASR reduction to serve as a reliable, easily repeatable biological measure of cocaine-induced brain changes that may enhance outcome prediction so that tailored treatments may be directed at those patients most vulnerable to relapse, given the restriction of resources for available for substance abuse treatment.
Primary Outcome
Magnitude of acoustic startle response as measured by electromyography of eyeblink.
Interventions
- PROCEDURE acoustic startle testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2006-09 |
| Est. Completion | 2011-07-19 |
What the finished NCT00430690 record still lists
NCT00430690 is an observational study that tracks outcomes without assigning an intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which acoustic startle testing is the first listed.
NCT00430690 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00430690 about?
NCT00430690 is a clinical study titled "Acoustic Startle Reduction In Cocaine Dependence". Chronic cocaine administration leads to changes in brain function that persist long after the acute withdrawal phase. The acoustic startle response (ASR) is a well characterized reflexive response to a sudden acoustic stimulus. The ASR is mediated by a simple 3-synapse subcortical circuit; it is mod...
What is the current status of trial NCT00430690?
This trial is currently completed. The enrollment target is 144 participants. The study started on 2006-09. Estimated completion is 2011-07-19.
What interventions are being tested in trial NCT00430690?
The interventions under investigation include: acoustic startle testing (PROCEDURE).
Who is sponsoring clinical trial NCT00430690?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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