Dopamine Enhancement of Fear Extinction Learning in PTSD (1R21MH108753)

NCT02560389 | Completed Phase 4 Results DMC

• 1 other identifier: 204583
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate a new use for a medication called levodopa (L-DOPA). L-DOPA has been approved for use in Parkinson 's disease, but not for Posttraumatic Stress Disorder (PTSD). L-DOPA is thought to enhance certain cognitive abilities that the investigators believe may be affected among women with PTSD. It is hypothesized that L-DOPA may enhance fear extinction learning to a conditioned fear stimulus. If this is true, L-DOPA may improve outcomes for those undergoing certain types of therapy for PTSD, though that aim is beyond the scope of this project. Additionally, the investigators are testing whether an individual's genetic profile affects how well L-DOPA works to enhance cognitive abilities.

Conditions

Stress Disorder, Post Traumatic

Keywords

Posttraumatic Stress Disorder; functional Magnetic Resonance Imaging; Levodopa (L-DOPA); Exposure Therapy; Fear Extinction

Outcome Measures

Primary Outcomes (1)

• Galvanic Skin Response

  Differential galvanic skin response will be assessed with respect to the conditioned stimulus versus the control stimulus. The investigators will compare, at an aggregate level, the differential galvanic skin response between the placebo, 100 mg, and 200 mg L-DOPA groups.

  Within 30 days of the MRI

Secondary Outcomes (2)

• Percentage Change in Functional Activation of Amygdala

  Within 30 days of the MRI

• Functional Activation of Anterior Cingulate Cortex

  Within 30 days of the MRI

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo administered in pill form once by mouth

Drug: Placebo

100mg L-DOPA

ACTIVE COMPARATOR

100mg levodopa administered in pill form once by mouth

Drug: Levodopa

200mg L-DOPA

ACTIVE COMPARATOR

200mg levodopa administered in pill form once by mouth

Drug: Levodopa

Interventions

Placebo DRUG

Sugar pill packaged to resemble levodopa

Placebo

Levodopa DRUG

EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.

Also known as: L-DOPA, Larodopa

100mg L-DOPA; 200mg L-DOPA

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• PTSD related to physical or sexual assault
• Medically healthy
• English speaking

You may not qualify if:

• 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)
• Electronic or magnetic implants, such as pacemakers
• Permanent makeup or tattoos with metallic dyes
• Currently pregnant
• A self-reported history of loss of consciousness (greater than 10 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Ahrenholtz R, Hiser J, Ross MC, Privratsky A, Sartin-Tarm A, James GA, Cisler JM. Unique neurocircuitry activation profiles during fear conditioning and extinction among women with posttraumatic stress disorder. J Psychiatr Res. 2021 Sep;141:257-266. doi: 10.1016/j.jpsychires.2021.07.007. Epub 2021 Jul 6.

  PMID: 34260994 DERIVED

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

Results Point of Contact

• Title: Josh Cisler
• Organization: University of Wisconsin School of Medicine and Public Health, University of Wisconsin, Madison

jcisler2@wisc.edu

608-263-6100

Study Officials

• Josh Cisler, PhD.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 25, 2015
• Study Start: March 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 25, 2019
• Results First Posted: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)