Effects of USP Methylene Blue on Cognitive and fMRI Brain Activity

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate whether low-dose USP methylene blue (MB) will: i) improve short-term memory retention in a delayed match-to-sample task, ii) reduce reaction time in a psychomotor vigilance test, and iii) enhance responses to a visual-motor task as measured by functional magnetic resonance imaging (fMRI).

A single low-dose MB or placebo will be orally administered to self-declared healthy adults using double-blind study design. Non-invasive fMRI data will be acquired before and after MB administration in the same subjects. Each study will take 2-3 hours, inclusive of an hour break in between.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio; Timothy Q. Duong
• Treatments: Methylene Blue

Criteria

Inclusion Criteria:

• Age 18 - 65 years, self declared healthy individuals

• English speaker and be able to give consent

Exclusion Criteria:

• Contraindication for MRI (pacemaker, metal implants, etc.)

• Claustrophobia

• Pregnant (child-bearing age females will be tested to exclude pregnancy onsite)

• Breast-feeding

• A history of hypersensitivity or allergy to methylene blue, glucose-6-phosphate dehydrogenase deficiency (determined via questionnaire)

• Neurological, mental, or cardiovascular disorders

• Liver, kidney disorders, kidney or liver transplant, hypertension, diabetes, etc.

• Known hypersensitivity to thiazide diuretics and phenothiazines

• A history of a psychotic disorder or panic disorder, violent or suicidal behavior, psychiatric institutionalization or imprisonment

• Any other condition, which in the opinion of the investigator, would put the participant at risk and warrant exclusion from the study

• Methemoglobinemia

• On any psychiatric serotonergic antidepressant medication or drugs of abuse currently or within the last 5 weeks

• History of panic attack

• Color Blindness