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NCT07742631

Overview

NCT ID: NCT07742631
Lead Sponsor: University of Witwatersrand, South AfricaOTHER
Official Title: The Neurocognitive Effects of Extended-Release Methylphenidate in Healthy Adults: A Review and Placebo-Controlled Randomized Controlled Trial
Brief Summary: This study evaluated the effects of methylphenidate (MPH), a stimulant medication commonly used to treat attention deficit hyperactivity disorder (ADHD), in healthy adults without ADHD. Although MPH is sometimes used by students and athletes to improve concentration or performance, its true benefits and risks in healthy individuals are uncertain.

The purpose of this study was to determine whether short-term use of MPH improves thinking ability, physical performance, cardiovascular function, balance, muscle strength, or heart safety in healthy adults.

In this randomized, double-blind, placebo-controlled crossover study, 28 healthy adult participants received either MPH (20 mg daily) or a placebo for 14 days, followed by a washout period and then the alternate treatment. Participants underwent repeated testing of heart rate, blood pressure, exercise capacity, balance, muscle strength, cognitive function, and heart electrical activity (ECG).

Status and Timeline

Status: Completed
Last Update Posted: Aug 3, 2026Actual
Start Date: Feb 6, 2023Actual
Primary Completion Date: Apr 15, 2024Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Healthy adults without a diagnosis of ADHD

Age 18 to 50 years

Willing to participate after being informed about the study

Willing to receive both methylphenidate and placebo during the study period

Willing to undergo non-invasive physiological, cognitive, cardiovascular, balance, and physical performance assessments

Able to comply with all study procedures and visits

Exclusion Criteria:

Current use of any medication that may affect cognitive performance, physical performance, electrocardiogram (ECG) findings, cardiovascular function, or balance

Any medical, neurological, musculoskeletal, psychiatric, or other condition that may interfere with the safe or successful completion of study assessments and physical performance testing

Any contraindication to methylphenidate administration

Study Plan

Study Type: Interventional
Phase: Early Phase 1
Enrollment: 30Actual
Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: University of the Witwatersrand

Similar Studies

Participant Group/Arms

Mehylphenidate -> PlaceboActive Comparator

Participants received extended-release methylphenidate 20 mg once daily for 14 days, followed by a washout period, then matching placebo capsules once daily for 14 days.

Drug: Methylphenidate Stimulant medication therapy

Other: Placebo Capsule(s)

Placebo -> MethylphenidatePlacebo Comparator

Matching placebo capsules administered orally once daily for 14 days. Capsules were identical in appearance to methylphenidate capsules to maintain blinding.

Drug: Methylphenidate Stimulant medication therapy