NCT04558112

Improving Therapeutic Learning for PTSD

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• PTSD
• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	L-DOPA	two gel capsules with 100mg L-DOPA (with 25 mg carbidopa to inhibit peripheral decarboxylase)
DRUG	Placebo	two gel capsules of placebo

Timeline

• Start date: 2021-02-18
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-09-22
• Last updated: 2023-08-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study