Improving Therapeutic Learning for PTSD

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04558112
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 22, 2020
Start date
Feb 18, 2021
Status verified
Jul 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
University of TexasAustinTexas78701
Josh Cisler, PhD (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53593-

Find similar trials in Austin, TX

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Texas· Austin, TXUniversity of Wisconsin· Madison, WI

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