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New treatment option for PTSD
Official title Improving Therapeutic Learning for PTSD
ClinicalTrials.gov ID: NCT04558112
What this study is testing
What is L-DOPA?
L-DOPA is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ptsd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
- English speaking
- Medically healthy
You likely can't join if
- internal ferromagnetic objects (such as electronic devices, surgical implants, shrapnel, etc.)
- major medical disorders (such as cancer)
- psychotic disorders
- neurocognitive disorders
- developmental disorders
- pregnancy
See the full eligibility criteria
- Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
- English speaking
- Medically healthy
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.