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CNS Stimulant

modafinil for Post-Traumatic Stress Disorder

Phase 2 & 3
Waitlist Available
Led By Tim A Kimbrell, MD
Research Sponsored by Biomedical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in p50 from baseline to 4 weeks
Awards & highlights

Summary

The purpose of this study is to determine if modafinil is more effective than placebo in the treatment of posttraumatic stress disorder (PTSD) in male combat veterans who have been deployed to Iraq or Afghanistan.

Eligible Conditions
  • Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in p50 from baseline to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in p50 from baseline to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinician Administered PTSD Scale (CAPS)
Secondary study objectives
Modified Stroop
event related potentials
eye-gaze tracking to facial stimuli

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: modafinilActive Control1 Intervention
Study participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks.
Group II: Sugar PillPlacebo Group1 Intervention
Study participants randomized to the placebo arm of the study will take matching capsules orally each day for 4 weeks.

Find a Location

Who is running the clinical trial?

Biomedical Research FoundationLead Sponsor
1 Previous Clinical Trials
426 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
282 Previous Clinical Trials
248,199 Total Patients Enrolled
National Center for Research Resources (NCRR)NIH
537 Previous Clinical Trials
316,976 Total Patients Enrolled
~3 spots leftby Sep 2025