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NCT00783276 · ClinicalTrials.gov registry record · Early Phase 1
An fMRI Study of SYN115 in Cocaine Dependent Subjects
A Early Phase 1 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
NCT00783276 is a Early Phase 1 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 26 participants.
The verdict
NCT00783276, a Early Phase 1 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The dopamine system is critical in modulation of reward and has been implicated in the initiation and maintenance of addiction (Volkow et al 2004). Medications that increase dopamine either directly or indirectly have been shown to have preliminary efficacy at reducing cocaine use in cocaine dependent subjects (Grabowski et al 2004a; Schmitz et al 2008). A novel class of medications that has recently been shown to indirectly modulate dopamine function is adenosine A2A receptor antagonists (Fuxe et al 2007). Based on their effect on dopamine function it has been suggested that these compounds may be efficacious in the treatment of drug addiction (Ferre et al 2007c). Before clinical efficacy studies are undertaken, more basic research on the effects of adenosine A2A antagonists on brain function and behavior are warranted. The aim of this study is to examine the acute effects of a single dose of the selective adenosine A2A antagonist (SYN115, Synosia Therapeutics, Chemical name: 4-Hydroxy-4-methyl-piperidine-1-carboxylic acid-(4-methoxy-7-morpholin-4-yl-benzothiazol-2-yl)-amide) on brain function and behavior in cocaine dependent individuals using functional magnetic resonance imaging (fMRI). To examine the effect of a single dose of SYN115 on brain function and behavior in cocaine dependent subjects. Hypotheses: 1. SYN115 100 mg will increase brain activation in the dorsolateral prefrontal cortex compared to placebo in cocaine dependent subjects performing a working memory task. 2. SYN115 100 mg will increase brain activation in the ventral striatum compared to placebo in cocaine dependent subjects performing a reversal learning task. 3. SYN115 100 mg will reduce brain activation in the anterior cingulate gyrus and amygdala compared to placebo in cocaine dependent subjects performing a cocaine-word Stroop task.
Interventions
- DRUG PLACEBO
- DRUG SYN115
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2008-10 |
| Est. Completion | 2013-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00783276
The ClinicalTrials.gov registry entry for NCT00783276 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PLACEBO is the first listed.
NCT00783276 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00783276 about?
NCT00783276 is a clinical study titled "An fMRI Study of SYN115 in Cocaine Dependent Subjects". The dopamine system is critical in modulation of reward and has been implicated in the initiation and maintenance of addiction (Volkow et al 2004). Medications that increase dopamine either directly or indirectly have been shown to have preliminary efficacy at reducing cocaine use in cocaine depende...
What is the current status of trial NCT00783276?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2008-10. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00783276?
The interventions under investigation include: PLACEBO (DRUG), SYN115 (DRUG).
Who is sponsoring clinical trial NCT00783276?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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