Improving therapeutic learning for PTSD in women
Improving Therapeutic Learning for PTSD
This study is testing whether a medication that affects dopamine can help women with PTSD from physical or sexual assault feel less fear during therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 2 sites (Austin, Texas and 1 other locations) |
| Trial ID | NCT04558112 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the consolidation of extinction memories during exposure therapy for PTSD by manipulating dopamine neurotransmission. It will involve 120 women aged 21-50 with PTSD related to physical or sexual assault, who will undergo treatment with L-DOPA or a placebo over 2-3 days. The study will assess how dopamine affects fear responses and the functional connectivity of dopaminergic neural networks post-therapy.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women aged 21-50 with a current diagnosis of PTSD due to physical or sexual assault.
Not a fit: Patients with major medical disorders, psychotic disorders, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatments for women suffering from PTSD.
How similar studies have performed: While the approach of manipulating dopamine in PTSD treatment is innovative, similar studies have shown promise in related areas of mental health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Austin, Texas and 1 other locations
- University of Texas — Austin, Texas, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Completed)
Study contacts
- Principal investigator: Zachary Stowe, MD — University of Wisconsin, Madison
- Study coordinator: Rachel Williams
- Email: rmwilliams5@wisc.edu
- Phone: 608-262-6375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.