Recruiting
Phase 2

PTSD Treatment

Sponsor:

University of Wisconsin, Madison

Code:

NCT04558112

Conditions

PTSD

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: Female

Age: 21 - 50

Healthy Volunteers: Accepted

Interventions

L-DOPA

Placebo

Study Details

Brief 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.

Conditions

PTSD

Post Traumatic Stress Disorder

Study ID

NCT04558112

Start date

Feb 18, 2021

Status verified date

Jul, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 100 mg L-DOPA

Complete a \~40 min fMRI scan with either hearing their trauma or neutral narrative, ingest a pill (placebo or 100mg L-DOPA) upon leaving the scanner and wait in a waiting room for \~45 minutes, then undergo a 7 min resting-state fMRI scan.Participants return \~24 hours later for Day 2 fMRI, in which they will complete a single \~40-minute fMRI scan while listening to either their trauma or neutral narrative.

placebo comparator: Placebo

Complete a \~40 min fMRI scan with either hearing their trauma or neutral narrative, ingest a pill (placebo or 100mg L-DOPA) upon leaving the scanner and wait in a waiting room for \~45 minutes, then undergo a 7 min resting-state fMRI scan.Participants return \~24 hours later for Day 2 fMRI, in which they will complete a single \~40-minute fMRI scan while listening to either their trauma or neutral narrative.

Interventions

L-DOPA

two gel capsules with 100mg L-DOPA (with 25 mg carbidopa to inhibit peripheral decarboxylase)

Placebo

two gel capsules of placebo

Primary outcome measure

  • Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1 [ Time Frame: up to 2 days ]

Central Contacts and Locations

Central contacts

Rachel Williams

608-262-6375rmwilliams5@wisc.edu

Locations

University of Texas

Recruiting

Austin, Texas, United States, 78701

Principal Investigator:

Josh Cisler, PhD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 30, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2023-08-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.