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NCT Number: NCT07380412

A Study to Evaluate the Effects of a Supplement on the Side Effects Associated With Stimulant Medications

This is a hybrid, two-arm, triple-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of the Stasis supplement on reducing oxidative stress, cortisol levels, and side effects associated with stimulant medications used for ADHD over a three-month period in adults.

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Key information

Conditions

ADHD Anxiety Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Brain Fog Fatigue Mental Disorders Mental Fatigue Nervous System Diseases Neurodevelopmental Disorders Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89118, United States

Location status: Recruiting

Location contact

Patrick Renner, MSc

CONTACT

[email protected]

424-245-0284

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-55 years
  • Currently prescribed stimulant medication for ADHD
  • Experiencing: sleep difficulty, irritability, anxiety, brain fog
  • Stable medication dose ≥3 months
  • Healthy with no uncontrolled chronic conditions
  • Stable on supplements ≥3 months if applicable
  • US resident
  • Willing to maintain current habits

Exclusion criteria

  • Chronic conditions (e.g. cancer, mental illness)
  • Use of psychiatric medications besides stimulants
  • Pregnancy, breastfeeding, thyroid, liver, kidney conditions
  • Recent smokers or heavy alcohol use
  • Night shift workers
  • Participation in other clinical trials
  • Allergies to product ingredients

Treatment and study plan

Stasis Daytime and Nighttime

Dietary Supplement

Daytime taken with stimulant medication and food. Nighttime taken 30 minutes before bedtime on an empty stomach.

Placebo

Dietary Supplement

Matched placebo product in taste and appearance.

Primary outcomes

  1. Change in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdG

    Time frame: Baseline and Month 3

    Measurement of oxidative stress and cortisol levels will be assessed using the following validated biomarkers:

    hs-CRP and serum cortisol from blood samples 8-hydroxy-2'-deoxyguanosine (8-OHdG) from urine samples

  2. Change in cortisol levels

    Time frame: Baseline and Month 3

    Serum cortisol concentration measured via blood draw.

Secondary outcomes

  1. Change in sleep quality

    Time frame: Baseline, Month 1, Month 2, and Month 3

    Sleep quality assessed via self-report questionnaire.

  2. Change in irritability

    Time frame: Baseline, Month 1, Month 2, and Month 3

    Irritability assessed via self-report questionnaire.

  3. Change in focus

    Time frame: Baseline, Month 1, Month 2, and Month 3

    Focus assessed via self-report questionnaire.

  4. Change in sociability

    Time frame: Baseline, Month 1, Month 2, and Month 3

    Sociability assessed via self-report questionnaire.

  5. Change in self-reported mood

    Time frame: Baseline, Month 1, Month 2, and Month 3

    Mood assessed via self-report questionnaire.

  6. Change in self-reported stress

    Time frame: Baseline, Month 1, Month 2, and Month 3

    Stress levels assessed via self-report questionnaire.

  7. Change in self-reported appetite

    Time frame: Baseline, Month 1, Month 2, and Month 3

    Appetite assessed via self-report questionnaire.

  8. Change in blood levels of Vitamin C

    Time frame: Baseline and Month 3

    Serum levels of Vitamin C measured via blood test.

  9. Change in blood levels of CoQ10

    Time frame: Baseline and Month 3

    Serum levels of Coenzyme Q10 measured via blood test.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Renner, MSc

CONTACT

[email protected]

4242450284

Sponsors and collaborators

Lead sponsor

Outliers, Inc.

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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