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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07380412
Enrollment
90
Registered
2026-02-02
Start date
2025-08-12
Completion date
2026-03-01
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Brain Fog, Sleep Disturbance

Keywords

ADHD, Anxiety

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.

Interventions

DIETARY_SUPPLEMENTStasis Daytime and Nighttime

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

DIETARY_SUPPLEMENTPlacebo

Matched placebo product in taste and appearance.

Sponsors

Outliers, Inc.
Lead SponsorINDUSTRY
Citruslabs
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdGBaseline and Month 3Measurement 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
Change in cortisol levelsBaseline and Month 3Serum cortisol concentration measured via blood draw.

Secondary

MeasureTime frameDescription
Change in sleep qualityBaseline, Month 1, Month 2, and Month 3Sleep quality assessed via self-report questionnaire.
Change in irritabilityBaseline, Month 1, Month 2, and Month 3Irritability assessed via self-report questionnaire.
Change in focusBaseline, Month 1, Month 2, and Month 3Focus assessed via self-report questionnaire.
Change in sociabilityBaseline, Month 1, Month 2, and Month 3Sociability assessed via self-report questionnaire.
Change in self-reported moodBaseline, Month 1, Month 2, and Month 3Mood assessed via self-report questionnaire.
Change in self-reported stressBaseline, Month 1, Month 2, and Month 3Stress levels assessed via self-report questionnaire.
Change in self-reported appetiteBaseline, Month 1, Month 2, and Month 3Appetite assessed via self-report questionnaire.
Change in blood levels of Vitamin CBaseline and Month 3Serum levels of Vitamin C measured via blood test.
Change in blood levels of CoQ10Baseline and Month 3Serum levels of Coenzyme Q10 measured via blood test.

Countries

United States

Contacts

CONTACTPatrick Renner, MSc
hello@citruslabs.com4242450284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026