Improving Therapeutic Learning for PTSD

NCT04558112 | Unknown Phase 2 FDA Drug

• 5 other identifiers: 2019-1567SMPH/PSYCHIATRY/PSYCHIATRY4R33MH108753-03A538900Protocol Version 6/26/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

PTSD; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1

  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

  up to 2 days

Secondary Outcomes (3)

• 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

Study Arms (2)

100 mg L-DOPA

EXPERIMENTAL

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.

Drug: L-DOPA

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

L-DOPA DRUG

two gel capsules with 100mg L-DOPA (with 25 mg carbidopa to inhibit peripheral decarboxylase)

100 mg L-DOPA

Placebo DRUG

two gel capsules of placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
• English speaking
• Medically healthy

You may not qualify if:

• 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
• heart disease
• hepatic impairment
• peptic ulcer disease
• COPD
• prescription medications that may interact with L-DOPA will not be permitted during a predetermined wash-out period
• Due to safety concerns, participants with these conditions will be ineligible to participate:
• Claustrophobia, or the inability to lie still in a confined space
• Major medical disorders (e.g., HIV, cancer)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Texas

Austin, Texas, 78701, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53593, United States

COMPLETED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Zachary Stowe, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Williams

CONTACT

608-262-6375; rmwilliams5@wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: February 18, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)