Improving Therapeutic Learning for PTSD with L-DOPA

This study is looking at whether a medication called L-DOPA can help women with Post-Traumatic Stress Disorder (PTSD) better learn from therapy. Participants will be women aged 21-50 who have PTSD from physical or sexual assault, speak English, and are medically healthy. You will receive either L-DOPA or a placebo (an inactive substance) in gel capsules. Researchers want to see if L-DOPA helps reduce negative emotional responses to trauma memories. The study aims to enroll 120 women and is currently unclear regarding its recruitment status.

Study design: This is an interventional study involving 120 women. It compares the effects of L-DOPA to a placebo.
What's involved: Participants will complete the stages of the study across 2-3 days, depending on individual needs.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint is measured at up to 2 days after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Improving Therapeutic Learning for PTSD

Recruiting

PHASE2Ages 21–50InterventionalTreatment

University of Wisconsin, Madison

~120 participants

Updated 2023-08-30 on ClinicalTrials.gov

What's tested:L-DOPAPlacebo

At a glance

Recruiting sites

1 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1

Measured over up to 2 days

Conditions

PTSD

Post Traumatic Stress Disorder

Where it's being run

2 sites across 2 states

Texas1

Wisconsin1

Study leadership

Zachary Stowe, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Rachel Williams

[email protected]

608-262-6375

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault

English speaking

Medically healthy

Exclusion

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

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

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

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

What this trial measures

Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1up to 2 days
Measured periodically through the narrative with a 10-point Likert scale of anxiety/distress (self-reported), with higher numbers indicating increased anxiety/distress. Measured on day 1 and day 2

Trialytics