L-DOPA
Drugtwo gel capsules with 100mg L-DOPA (with 25 mg carbidopa to inhibit peripheral decarboxylase)
NCT Number: NCT04558112
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.
Interested in participating?
Request Info21 year–50 year
Female
Interventional
Phase 2
University of Texas, Austin, Texas, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional Exclusion Criteria at UT-Austin:
Due to safety concerns, participants with these conditions will be ineligible to participate:
Due to their effects on image quality, participants with the following MAY be ineligible to participate per Principal Investigator's judgment:
two gel capsules with 100mg L-DOPA (with 25 mg carbidopa to inhibit peripheral decarboxylase)
two gel capsules of placebo
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
Time frame: 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
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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