Effects of Sulfasalazine on BOLD Response to Alcohol Cues

NCT01312129 | Completed Results

• 1 other identifier: 20-381
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Dependence

Keywords

Alcohol; Sulfasalazine

Outcome Measures

Primary Outcomes (1)

• % BOLD Response Increase Above Baseline

  Test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). BOLD response refers to brain activation in response to the presence of oxygen in a particular part of the brain. To test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment. During the fMRI scan session, participants will be presented with the alcohol cue task. We will compare the difference in BOLD response during the presence of alcohol vs. a novel substance during the alcohol cue task. Outcome data collected during the alcohol cue task will provide us with BOLD response data for each intervention period. We will analyze the outcome data using FSL (Oxford Centre for Functional MRI of the Brain (FMRIB) Software - a collection of functional and structural brain image analysis tools).

  Over two weeks

Study Arms (2)

Sulfasalazine

EXPERIMENTAL

Sulfasalazine 1500 mg

Drug: Sulfasalazine

Placebo

PLACEBO COMPARATOR

Placebo capsule x 3 doses 12 hours apart

Drug: Placebo

Interventions

Sulfasalazine DRUG

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

Sulfasalazine

Placebo DRUG

Placebo capsule x 3 doses 12 hours apart

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age with
• Alcohol Dependence

You may not qualify if:

• Medical or MRI Contraindications
• Pregnancy
• Allergy to Sulfa medications

Sponsors & Collaborators

• The Mind Research Network: lead

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Sulfasalazine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Kent Hutchison, Ph.D.
• Organization: The Mind Research Network

khutchison@mrn.org

720-663-0745

Study Officials

• Kent E Hutchison, PhD

  The Mind Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Research

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 10, 2011
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 22, 2014
• Results First Posted: September 22, 2014

Record last verified: 2014-09

Locations

US (1)