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

January 28, 2026 updated by: Outliers, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Recruiting
        • Citruslabs
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator
Dietary supplement: Placebo
Matched placebo product in taste and appearance.
Experimental: Stasis Supplement
Dietary supplement: Stasis Daytime and Nighttime
Daytime taken with stimulant medication and food. Nighttime taken 30 minutes before bedtime on an empty stomach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and Month 3
Change in cortisol levels
Time Frame: Baseline and Month 3
Serum cortisol concentration measured via blood draw.
Baseline and Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep quality
Time Frame: Baseline, Month 1, Month 2, and Month 3
Sleep quality assessed via self-report questionnaire.
Baseline, Month 1, Month 2, and Month 3
Change in irritability
Time Frame: Baseline, Month 1, Month 2, and Month 3
Irritability assessed via self-report questionnaire.
Baseline, Month 1, Month 2, and Month 3
Change in focus
Time Frame: Baseline, Month 1, Month 2, and Month 3
Focus assessed via self-report questionnaire.
Baseline, Month 1, Month 2, and Month 3
Change in sociability
Time Frame: Baseline, Month 1, Month 2, and Month 3
Sociability assessed via self-report questionnaire.
Baseline, Month 1, Month 2, and Month 3
Change in self-reported mood
Time Frame: Baseline, Month 1, Month 2, and Month 3
Mood assessed via self-report questionnaire.
Baseline, Month 1, Month 2, and Month 3
Change in self-reported stress
Time Frame: Baseline, Month 1, Month 2, and Month 3
Stress levels assessed via self-report questionnaire.
Baseline, Month 1, Month 2, and Month 3
Change in self-reported appetite
Time Frame: Baseline, Month 1, Month 2, and Month 3
Appetite assessed via self-report questionnaire.
Baseline, Month 1, Month 2, and Month 3
Change in blood levels of Vitamin C
Time Frame: Baseline and Month 3
Serum levels of Vitamin C measured via blood test.
Baseline and Month 3
Change in blood levels of CoQ10
Time Frame: Baseline and Month 3
Serum levels of Coenzyme Q10 measured via blood test.
Baseline and Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Outliers, Inc.

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20764

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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