Improving Therapeutic Learning for PTSD
Overview
- Phase
- Phase 2
- Intervention
- L-DOPA
- Conditions
- PTSD
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
Specific Aim 1: Test the degree to which exogeneous manipulations of dopamine neurotransmission affect exposure therapy learning across multiple indices. Hypothesis: L-DOPA will decrease measures of fear responding across indices. Specific Aim 2: Test the degree to which post-exposure functional connectivity within dopaminergic neural networks mediates the effect of dopaminergic manipulation on fear responding after exposure therapy. Hypothesis: L-DOPA will predict enhanced post-exposure dopaminergic functional connectivity, which in turn predicts decrease fear recall.
Investigators
Eligibility 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
Arms & Interventions
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.
Intervention: L-DOPA
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1
Time Frame: up to 2 days
Measured periodically through the narrative with a 10-point Likert scale of anxiety/distress (self-reported), with higher numbers indicating increased anxiety/distress. Measured on day 1 and day 2
Secondary Outcomes
- Change in Skin Conductance Response (SCR) to trauma scripts on Day 2 compared to Day 1(up to 2 days)
- Change in Heart Rate (HR) to trauma scripts on Day 2 compared to Day 1(up to 2 days)
- Change in amygdala-hippocampus functional connectivity on Day 2 compared to Day 1(up to 2 days)