Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
White River Junction Veterans Affairs Medical Center
92 participants
Dec 18, 2023
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria21
- Age 19-70 years
- Weight ≥ 45 kg
- Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
- Eligible for Veterans Affairs healthcare
- If person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.
- Able to read, understand, and sign the informed consent document.
- Exclusion (unable to participate) Criteria:
- Pregnant or lactating person
- Moderate or severe hepatic impairment (Child-Pugh B or C)
- History of prior hepatic decompensation
- Current use of drugs listed as having significant drug interactions on prescribing label
- Advanced liver disease
- Current or prior hepatitis B infection
- Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor
- Current HCV infection
- Current psychosis or mania
- Significant suicidal ideation
- Unstable medical conditions
- Current severe alcohol or substance use disorder (excluding nicotine)
- Evidence-based PTSD psychotherapy changes in the past two months
- Evidence-based PTSD medication changes in the past two months
Interventions
Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
Compounded, inactive pill equal in appearance to active study drug
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05637879