Addressing Cognitive Fog in Long-COVID Patients

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess two options to help patients better manage the cognitive fog and emotional distress that may be associated with having Long-COVID. Long-COVID is post-COVID conditions or symptoms lasting more than four weeks after infection. Clinicians from the UPMC Long-COVID Clinic leading this study are evaluating the utility of computer-based evaluation of COVID-related cognitive fog and the helpfulness of two intervention strategies to treat moderate cognitive impairment using a randomized trial. The two intervention strategies include 1) a standardized dosing of amphetamine/dextroamphetamine medication that has been used to improve cognitive fog; and 2) a digital behavioral tool with an embedded health coach that is used on a mobile phone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eva Szigethy
• Collaborator: The Beckwith Institute
• Treatments: Adderall; Amphetamine; Dextroamphetamine

Criteria

Inclusion Criteria:

• History of SARS-CoV-2 infection as defined as a positive PCR or home antigen test

• Patients with Long-COVID as defined as COVID symptoms that persist for three months or longer.

• Between the ages of 21 and 65

• Moderate cognitive impairment (MOCA score to meet criteria is < or =18) present for at least 3 months

• Response of "No" to the screening question, "Are you pregnant or do you plan to become pregnant in the next 3 months?"

• Access to a smartphone

Exclusion Criteria:

• History of dementia, psychosis, mania, addiction or current conditions requiring immediate hospitalization

• Previous adverse or allergic reaction to Adderall or other amphetamines

• Pre-existing cardiac or kidney condition, severe hypertension, glaucoma, advanced arteriosclerosis, hyperthyroidism, and taking an MAOI within the past 14 days

• Current or past substance misuse

• Previous use of RxWell (completed 3 or more techniques)

• Current use of amphetamine-dextroamphetamine

• History of uncontrolled blood pressure

• Subjects taking Methylphenidate; Lisdexamfetamine; non-Adderall amphetamine products; Atomoxetine; Viloxazine; Modafinil; Armodafinil; Nortriptyline and other tricyclic drugs; Bupropion; Tramadol; and Monoamine Oxidase Inhibitor (MAOI) drugs (including Linezolid).

• Inability to pay for study medication.