Actively Recruiting
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
Led by White River Junction Veterans Affairs Medical Center · Updated on 2025-04-24
92
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV).
CONDITIONS
Official Title
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19-70 years
- Weight at least 45 kg
- Diagnosed with PTSD using CAPS-5 within seven days before enrollment
- Eligible for Veterans Affairs healthcare
- If able to bear children, must use effective birth control or abstain
- Able to read, understand, and sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Moderate or severe liver impairment (Child-Pugh B or C)
- History of liver failure
- Using drugs with significant interactions listed on the study drug label
- Advanced liver disease
- Current or past hepatitis B infection
- Previous use of GLE/PIB or certain hepatitis C drugs
- Current hepatitis C infection
- Current psychosis or mania
- Significant suicidal thoughts
- Unstable medical conditions
- Severe alcohol or substance use disorder (excluding nicotine)
- Changes in PTSD psychotherapy in past two months
- Changes in PTSD medications in past two months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
White River Junction VAMC
White River Junction, Vermont, United States, 05001
Actively Recruiting
Research Team
B
Bradley V Watts, MD, MPH
CONTACT
E
Emily Colon, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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