Methylphenidate and Response to Alcohol Cues Pilot Study

NCT06063200 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB202301428
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate, also known as Ritalin, affects responses to alcohol cues. The study will observe the effects of methylphenidate or a placebo on attentional bias and craving responses to alcohol cues through fMRI, EEG, and behavioral testing. Participants will be involved in one remote and two in-person sessions.

Conditions

Alcohol Use Disorder; Attention Deficit Hyperactivity Disorder

Keywords

fMRI; EEG

Outcome Measures

Primary Outcomes (3)

• Neural responses to cues

  Cue-elicited EEG and fMRI responses. We will contrast brain activation following alcohol images with brain activation following neutral images.

  15 minutes

• Self-reported craving

  Craving following presentation of alcohol and neutral images will be reported using 0-10 visual analog scales. We will contrast craving following the alcohol images with craving following the neutral images.

  15 minutes

• Accuracy on the attentional blink task

  We will contrast accuracy during alcohol distractor trials with neutral distractor trials for "lags" of 8 versus 2 images following the distractor.

  5 minutes

Secondary Outcomes (4)

• Self-reported anxiety

  15 minutes

• Continuous performance task omission errors

  5 minutes

• Attention network task reaction times

  15 minutes

• Heart rate

  15 minutes

Study Arms (2)

crossover 1: methylphenidate, placebo

OTHER

methylphenidate (single dose, oral, 20 mg, immediate release) followed by placebo (single dose, oral)

Drug: Methylphenidate Pill

crossover 2: placebo, methylphenidate

OTHER

placebo (single dose, oral) followed by methylphenidate (single dose, oral, 20 mg, immediate release)

Drug: Methylphenidate Pill

Interventions

Methylphenidate Pill DRUG

Single encapsulated pill

Also known as: Ritalin

crossover 1: methylphenidate, placebo; crossover 2: placebo, methylphenidate

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults ages 18-25 years
• Meets DSM-5 criteria for AUD
• Meets DSM-5 criteria for ADHD
• Fluent in English
• Normal or corrected to normal vision

You may not qualify if:

• Meets DSM-5 criteria for bipolar disorder, psychotic disorders, neurological disorders, or substance use disorders other than AUD.
• Participant routinely uses psychoactive drugs or medications except for non-dependent marijuana or nicotine use (due to common use of these substances in individuals with AUD).
• Participant has contraindications for taking methylphenidate.
• Participant has contraindications for being in an MRI machine
• Self-reported history of high blood pressure over 140/90 or consistent readings of 140/90 or above upon arrival for a session.
• History of seizure disorder
• Liver disease
• Participant is currently pregnant or trying to become pregnant

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Alcoholism; Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 2, 2023
• Study Start: March 20, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-07

Locations

US (1)