Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Therapeutic Learning for PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558112
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : May 19, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
PTSD Post Traumatic Stress Disorder Drug: L-DOPA Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Therapeutic Learning for PTSD
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
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.
Drug: L-DOPA
two gel capsules with 100mg L-DOPA (with 25 mg carbidopa to inhibit peripheral decarboxylase)

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.
Drug: Placebo
two gel capsules of placebo




Primary Outcome Measures :
  1. Change in negative emotional responding to trauma scripts on Day 2 compared to Day 1 [ 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


Secondary Outcome Measures :
  1. Change in Skin Conductance Response (SCR) to trauma scripts on Day 2 compared to Day 1 [ 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

  2. Change in Heart Rate (HR) to trauma scripts on Day 2 compared to Day 1 [ 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

  3. Change in amygdala-hippocampus functional connectivity on Day 2 compared to Day 1 [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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
  • active substance use disorders
  • pregnancy
  • breastfeeding
  • use of Monoamine oxidase inhibitors (MAO-I) in past two weeks is exclusionary

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)
  • Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents), as these may heat, pull, or twist in the strong magnetic field of the MRI scanner
  • Electronic or magnetic implants, such as pacemakers, as these may stop working
  • Permanent makeup or tattoos with metallic dyes
  • A positive pregnancy test (for females), since the effect of strong magnetic fields and L-Dopa on the developing fetus remains unknown and inconclusive. (all female participants of childbearing potential will have a pregnancy test on the day of the MRI scan. Participants who test positive would be notified of this positive result)
  • A self-reported history of loss of consciousness (greater than 30 minutes)
  • Physical disabilities that prohibit task performance (such as blindness or deafness)
  • Psychotic disorders (e.g., schizophrenia)
  • Any other condition that the investigator believes might put the participant at risk

Due to their effects on image quality, participants with the following MAY be ineligible to participate per Principal Investigator's judgment:

  • Medications which may affect image quality (e.g., water pills)
  • Nonremovable dental implants, such as braces or upper permanent retainers, as these will distort the MRI images we collect (note: filings, crowns, and silver or gold teeth are OK)
  • Any other condition, medication, or implant that the investigator believes would degrade image quality or render data unusable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558112


Contacts
Layout table for location contacts
Contact: Josh Cisler, PhD 608-890-6675 jcisler2@wisc.edu

Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53593
Contact: Chloe M Schomaker       cschomaker@wisc.edu   
Principal Investigator: Josh Cisler, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute of Mental Health (NIMH)
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04558112    
Other Study ID Numbers: 2019-1567
SMPH/PSYCHIATRY/PSYCHIATRY ( Other Identifier: UW Madison )
4R33MH108753-03 ( U.S. NIH Grant/Contract )
A538900 ( Other Identifier: UW Madison )
Protocol Version 4/19/2021 ( Other Identifier: UW Madison )
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs