Improving Therapeutic Learning for PTSD
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: PTSD, Post Traumatic Stress Disorder
In brief
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.
Key facts
- Study ID
- NCT04558112
- Run by
- University of Wisconsin, Madison
- People needed
- 120
- Starts
- 2021-02-18
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2023-08-30
Who can join
Age: 21 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
- English speaking
- Medically healthy
You may not qualify 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
- 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
Where it is running
- University of Texas — Austin, Texas, United States (enrolling)
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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