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Central Nervous System Stimulant

Methylphenidate for Normal Brain Function

Phase 1
Waitlist Available
Led By Dardo G Tomasi, Ph.D.
Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females between 18 and 55 years of age
Have or had any prior experience with alcohol use or stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, diet pills (prescription or over the counter), caffeine, and others but did not have a substance use disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights

Study Summary

This trial is studying the brain chemical dopamine and how it is affected by the drug methylphenidate.

Who is the study for?
Adults aged 18-55 who have used alcohol or stimulants but aren't dependent, and can lie flat for up to 2 hours. They must not be pregnant, breastfeeding, or have metal implants that affect MRI scans. Participants should be healthy without major medical issues affecting the brain and not on certain medications.Check my eligibility
What is being tested?
The study tests how methylphenidate (a stimulant) affects dopamine levels in the brain using PET/MRI scans. Participants will receive either methylphenidate or a placebo orally and intravenously across different visits to compare effects on mood and cognition.See study design
What are the potential side effects?
Methylphenidate may cause nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting or headache. The MRI scan is generally safe but may cause discomfort due to lying still for a long period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I have used stimulants or alcohol but never had an addiction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ventral Striatum
Secondary outcome measures
Heart rate, BP, Respiration Rate
Pupil size, Eye Blinks, HR, BP, Respiration Rate

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 2 Oral PL/IV MPActive Control1 Intervention
Oral Placebo/IV Methylphenidate
Group II: 1:Oral MP- IV PLActive Control1 Intervention
Oral Methylphenidate /IV Placebo
Group III: 3: Oral PL/IV PLPlacebo Group1 Intervention
Oral Placebo/IV Placebo

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
796 Previous Clinical Trials
1,361,398 Total Patients Enrolled
5 Trials studying Normal Physiology
2,026 Patients Enrolled for Normal Physiology
Dardo G Tomasi, Ph.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
2 Previous Clinical Trials
304 Total Patients Enrolled
2 Trials studying Normal Physiology
304 Patients Enrolled for Normal Physiology

Media Library

Methylphenidate (Central Nervous System Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT03326245 — Phase 1
Normal Physiology Research Study Groups: 2 Oral PL/IV MP, 3: Oral PL/IV PL, 1:Oral MP- IV PL
Normal Physiology Clinical Trial 2023: Methylphenidate Highlights & Side Effects. Trial Name: NCT03326245 — Phase 1
Methylphenidate (Central Nervous System Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03326245 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participation in this trial above eighty years old?

"Eligibility for this research requires patients to be between 18 and 55 years old. For those outside that age range, there are 8 separate trials available - 1 specifically designed for minors and 7 tailored towards elderly citizens."

Answered by AI

Are there still vacancies in this clinical investigation?

"The clinical trial entry hosted on the official trials registry states that this particular study is not actively recruiting candidates at present. The information was last updated in July 2022, however there are currently 16 other studies searching for participants."

Answered by AI

Have the Food and Drug Administration granted approval for a 2 Oral PL/IV MP regimen?

"As this is an early-stage Phase 1 trial, little data exists to support its safety and efficacy. Due to this fact, our team has provisionally ranked 2 Oral PL/IV MP a 1 on the risk scale."

Answered by AI

May I be included in the sampling for this investigation?

"This trial is recruiting 40 individuals aged 18-55 who possess pristine physiological characteristics. In addition, applicants must be willing to abstain from any drug use on scheduled testing days and have no prior experience with alcohol or stimulant drugs such as cocaine, methylphenidate, amphetamine or methamphetamine, diet pills (prescription or over the counter), caffeine and other substances but not a substance use disorder. Males and females are both eligible for enrollment in this study."

Answered by AI
~3 spots leftby Mar 2025