NCT04558112 Improving Therapeutic Learning for PTSD
| NCT ID | NCT04558112 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Wisconsin, Madison |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-02-18 |
| Primary Completion | 2023-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2021-02-18 with a primary completion date of 2023-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The proposed project seeks to demonstrate the engagement of post-exposure dopamine neurotransmission and downstream acute reorganization of dopaminergic resting-state neural networks as a means of increasing consolidation of extinction memories formed during analogue exposure therapy in adult women with PTSD. Participants will include 120 women aged 21-50 with a current diagnosis of PTSD related to physical or sexual assault, English speaking, and medically healthy. Participants will complete the stages of the study across 2-3 days, depending on participant need.
Eligibility Criteria
Inclusion Criteria: * Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault * English speaking * Medically healthy Exclusion Criteria: * internal ferromagnetic objects (such as electronic devices, surgical implants, shrapnel, etc.) * major medical disorders (such as cancer) * psychotic disorders * neurocognitive disorders * developmental disorders * pregnancy * breastfeeding * use of Monoamine oxidase inhibitors (MAO-I) in past two weeks is exclusionary Additional Exclusion Criteria at UT-Austin: * heart disease * hepatic impairment * peptic ulcer disease * COPD * prescription medications that may interact with L-DOPA will not be permitted during a predetermined wash-out period Due to safety concerns, participants with these conditions will be ineligible to participate: * Claustrophobia, or the inability to lie still in a confined space * Major medical disorders (e.g., HIV, cancer) * Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents), as these may heat, pull, or twist in the strong magnetic field of the MRI scanner * Electronic or magnetic implants, such as pacemakers, as these may stop working * Permanent makeup or tattoos with metallic dyes * A positive pregnancy test (for females), since the effect of strong magnetic fields and L-Dopa on the developing fetus remains unknown and inconclusive. (all female participants of childbearing potential will have a pregnancy test on the day of the MRI scan. Participants who test positive would be notified of this positive result) * A self-reported history of loss of consciousness (greater than 30 minutes) * Physical disabilities that prohibit task performance (such as blindness or deafness) * Psychotic disorders (e.g., schizophrenia) * Any other condition that the investigator believes might put the participant at risk Due to their effects on image quality, participants with the following MAY be ineligible to participate per Principal Investigator's judgment: * Medications which may affect image quality (e.g., water pills) * Nonremovable dental implants, such as braces or upper permanent retainers, as these will distort the MRI images we collect (note: filings, crowns, and silver or gold teeth are OK) * Any other condition, medication, or implant that the investigator believes would degrade image quality or render data unusable
Contact & Investigator
Zachary Stowe, MD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT04558112 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 50 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04558112 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04558112 currently recruiting?
Yes, NCT04558112 is actively recruiting participants. Contact the research team at rmwilliams5@wisc.edu for enrollment information.
Where is the NCT04558112 trial being conducted?
This trial is being conducted at Austin, United States, Madison, United States.
Who is sponsoring the NCT04558112 clinical trial?
NCT04558112 is sponsored by University of Wisconsin, Madison. The principal investigator is Zachary Stowe, MD at University of Wisconsin, Madison. The trial plans to enroll 120 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.