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

NCT07380412 | Recruiting

• 1 other identifier: 20764
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD; Sleep Disturbance; Brain Fog

Keywords

ADHD; Anxiety

Outcome Measures

Primary Outcomes (2)

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

  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

  Serum cortisol concentration measured via blood draw.

  Baseline and Month 3

Secondary Outcomes (9)

• Change in sleep quality

  Baseline, Month 1, Month 2, and Month 3

• Change in irritability

  Baseline, Month 1, Month 2, and Month 3

• Change in focus

  Baseline, Month 1, Month 2, and Month 3

• Change in sociability

  Baseline, Month 1, Month 2, and Month 3

• Change in self-reported mood

  Baseline, Month 1, Month 2, and Month 3

Study Arms (2)

Stasis Supplement

EXPERIMENTAL

Dietary Supplement: Stasis Daytime and Nighttime

Placebo Comparator

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Matched placebo product in taste and appearance.

Placebo Comparator

Stasis Daytime and Nighttime DIETARY_SUPPLEMENT

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

Stasis Supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Outliers, Inc.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Parasomnias; Mental Fatigue; Anxiety Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Central Study Contacts

Patrick Renner, MSc

CONTACT

4242450284; hello@citruslabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Care Provider, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: February 2, 2026
• Study Start: August 12, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)