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NCT01312129 · ClinicalTrials.gov registry record · NA
Effects of Sulfasalazine on BOLD Response to Alcohol Cues
A NA study, sponsored by The Mind Research Network.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT01312129 is a NA study that has completed, run by The Mind Research Network. The registered enrollment target is 23 participants.
The verdict
NCT01312129, a NA study, has completed, sponsored by The Mind Research Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
The overarching objective of this pilot study is to apply both neuroimaging and pharmacogenetic tools to the study of alcohol dependence. This proposed research will provide a mechanistic test of the function of the genetic variation. The specific aims and hypotheses are to test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). To test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment on BOLD difference maps for the contrast alcohol minus control. We will also explore whether specific genetic variations influence this effect. A double-blind, placebo-controlled 2 (Medication: Sulfasalazine 1500 mg vs. placebo control) x 2 (Cue: Alcohol Cue vs. Control cue) within-subjects, crossover design will be used to test the hypothesis that Sulfasalazine reduces the BOLD response in the striatum and prefrontal cortex after exposure to alcohol cues. Twenty alcohol-dependent participants will complete two rounds of the study medication followed by an functional magnetic resonance imaging (fMRI) scan, during which they will complete an alcohol cue-exposure task. The order of the medication condition will be counterbalanced such that subjects will be randomly assigned to receive either Sulfasalazine (1500 mg) in the first session and placebo in the second session one week later (or vice versa). This pilot study will help to determine whether NMDA receptors play a role in cue-elicited activation of key areas of the brain implicated in the development and maintenance of substance use disorders. Furthermore, if Sulfasalazine reduces cue-elicited activation of these brain regions, as hypothesized; this study will lay the groundwork for a larger trial on the efficacy of Sulfasalazine as a treatment for substance use disorders.
Interventions
- DRUG Placebo
- DRUG Sulfasalazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01312129
The ClinicalTrials.gov registry entry for NCT01312129 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Mind Research Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01312129 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01312129 about?
NCT01312129 is a clinical study titled "Effects of Sulfasalazine on BOLD Response to Alcohol Cues". The overarching objective of this pilot study is to apply both neuroimaging and pharmacogenetic tools to the study of alcohol dependence. This proposed research will provide a mechanistic test of the function of the genetic variation. The specific aims and hypotheses are to test whether Sulfasalazin...
What is the current status of trial NCT01312129?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2010-03. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01312129?
The interventions under investigation include: Placebo (DRUG), Sulfasalazine (DRUG).
Who is sponsoring clinical trial NCT01312129?
This trial is sponsored by The Mind Research Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
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