PTSD, Post Traumatic Stress Disorder
Conditions
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.
Interventions
DRUGL-DOPA
two gel capsules with 100mg L-DOPA (with 25 mg carbidopa to inhibit peripheral decarboxylase)
DRUGPlacebo
two gel capsules of placebo
Sponsors
National Institute of Mental Health (NIMH)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Conductance Response (SCR) to trauma scripts on Day 2 compared to Day 1 | up to 2 days | SCR data will be acquired on a BIOPAC MP150 Data Acquisition System (BIOPAC Systems, Inc.) with electrodes placed on participant's left hand. Average intensity of participant skin conductance will be reported. Measured on day 1 and day 2 |
| Change in Heart Rate (HR) to trauma scripts on Day 2 compared to Day 1 | up to 2 days | Heart rate data will be acquired with a pulse oximeter placed on participant's left hand. Average intensity of participant heart rate will be reported. Measured on day 1 and day 2 |
| Change in amygdala-hippocampus functional connectivity on Day 2 compared to Day 1 | up to 2 days | Measured by 3T functioning magnetic resident imaging (fMRI), time courses of activity of the hippocampus and amygdala will be correlated on day 1 and day 2, then compared between the groups. |
Countries
United States
Contacts
Primary ContactRachel Williams
Outcome results
None listed