Overview

Improving Therapeutic Learning for PTSD

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Levodopa
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

- active substance use disorders

- pregnancy

- breastfeeding

- use of Monoamine oxidase inhibitors (MAO-I) in past two weeks is exclusionary

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