Investigation of Locus Coeruleus Function in Sustained Attention

NCT06041048 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 1939774
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The norepinephrine-producing locus coeruleus (LC) is thought to be central to a wide array of cognitive functions, like attention and goal pursuit, and has been implicated in dysfunctions including attention deficit hyperactivity disorder and schizophrenia. The goal of this proposal is to develop methods that permit measurement of activity in the human LC. Because the LC is small and located in the pons, the Investigators will use high resolution magnetic resonance imaging techniques tailored to the brainstem environment, including neuromelanin-sensitive images shown to delineate the LC, combined with pharmacological manipulation to confirm the location of functional activity.

Conditions

Attention - no Condition is Being Assessed - Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Brain activity - BOLD response

  1 hour

Secondary Outcomes (1)

• Attention on Oddball and POP task

  1 hour

Study Arms (2)

Modafinil

ACTIVE COMPARATOR

Single oral dose (200 mg) of medication versus placebo given to healthy control subjects

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Oral placebo

Drug: Modafinil

Interventions

Modafinil DRUG

Single dose (200 mg) of medication versus placebo given to healthy control subjects

Also known as: Provigil

Modafinil; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 - 60 years of age,
• Typically developing, healthy adult

You may not qualify if:

• History of schizophrenia, other forms of psychosis,
• Specific or focal neurological disorder or severe alcohol or drug use disorder within the past 5 years
• History of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants, or who have had recent history of myocardial infarction or unstable angina.
• Volunteers with known hypersensitivity to modafinil or armodafinil or its inactive ingredients
• Known allergy/sensitivity or any hypersensitivity to components of modafinil or its formulation
• Inability to swallow tablets or tolerate oral medication;
• Pregnant or nursing (participants will be required to have a negative pregnancy test)
• Contraindication for MRI scanning (metal implants, pacemakers, metal foreign bodies, or pregnancy)
• Use of psychotropic medication within the past week
• Claustrophobic and not comfortable being in a small space may also not want to participate

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Julie Schweitzer, PhD

CONTACT

9167030450; jschweitzer@ucdavis.edu

Jared Borden, MA

CONTACT

9167030294; Jborden@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: September 18, 2023
• Study Start: October 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within two years after data are analyzed by the investigative team. How long it will be available is determined by the NIH.

Locations

US (1)