CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Sulfasalazine +1 moredrug
Likely dose
Sulfasalazine 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01312129
NCT01312129N/ACompleted

Effects of Sulfasalazine on BOLD Response to Alcohol Cues

The Mind Research Network·interventional·Posted Mar 10, 2011·Updated Sep 22, 2014

In Brief

A clinical study evaluating Sulfasalazine and Placebo for Alcohol Dependence. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 10, 2011
Enrollment StartMar 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.3 years ago

Interventions

Sulfasalazinedrug

500mg capsules of Sulfasalazine x 3 doses 12 hours apart.

Placebodrug

Placebo capsule x 3 doses 12 hours apart