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Stimulant
Methylphenidate for Alcoholism
Phase < 1
Recruiting
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults ages 18-25 years
Normal or corrected to normal vision
Must not have
Participant has contraindications for taking methylphenidate
Self-reported history of high blood pressure over 140/90 or consistent readings of 140/90 or above upon arrival for a session
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes
Awards & highlights
Summary
"This trial aims to see if taking a medication called methylphenidate, also known as Ritalin, affects how people respond to alcohol-related cues. Participants will take either the medication or a placebo
Who is the study for?
This trial is for adults aged 18-25 who have been diagnosed with both Alcohol Use Disorder (AUD) and Attention Deficit Hyperactivity Disorder (ADHD). Participants must speak English fluently and have normal or corrected-to-normal vision.
What is being tested?
The study tests if a single dose of methylphenidate, known as Ritalin, changes attention levels and affects responses to alcohol-related cues. It involves one remote session and two in-person sessions using fMRI, EEG, and behavioral testing to compare the effects against a placebo.
What are the potential side effects?
Methylphenidate may cause side effects like nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting or headaches. More serious side effects can include heart problems or increased blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 25 years old.
Select...
My vision is normal or corrected to normal with glasses or contacts.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take methylphenidate due to health reasons.
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I have high blood pressure readings of 140/90 or higher.
Select...
I have been diagnosed with bipolar, psychotic, neurological disorders, or substance use disorders other than alcohol use.
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I have a history of seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accuracy on the attentional blink task
Neural responses to cues
Self-reported craving
Secondary outcome measures
Attention network task reaction times
Continuous performance task omission errors
Heart rate
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: crossover 2: placebo, methylphenidateExperimental Treatment1 Intervention
placebo (single dose, oral) followed by methylphenidate (single dose, oral, 20 mg, immediate release)
Group II: crossover 1: methylphenidate, placeboExperimental Treatment1 Intervention
methylphenidate (single dose, oral, 20 mg, immediate release) followed by placebo (single dose, oral)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate Pill
2018
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,365 Total Patients Enrolled
7 Trials studying Alcoholism
401 Patients Enrolled for Alcoholism
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