Skip to main content
OpenTrials
Completed

NCT Number: NCT06063200

Methylphenidate and Response to Alcohol Cues Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

Recent studies have revealed a robust link between attentional ability and resilience against stress-related psychopathology, in general, and against alcohol use disorder (AUD) specifically. For example, self-reported attentional ability correlates with scales of psychological resilience and with lower alcohol misuse in at-risk individuals. One mechanism by which attention may relate to resilience in AUD is through its effects on alcohol cue reactivity. Exposure to alcohol cues can induce motivation to drink alcohol for those with AUD. Leveraging the high rates of co-morbidity of AUD and attention-deficit/hyperactivity disorder, this pilot study seeks to demonstrate whether experimentally enhancing attention in individuals with both AUD and attentional deficits associated with attention-deficit/hyperactivity disorder (ADHD) reduces markers of addiction severity (i.e., craving and attentional bias responses to alcohol cues) and will explore the neural and behavioral mechanisms. Methylphenidate not only improves sustained attention, but in users of cocaine and methamphetamine, it was previously shown to reduce craving, attentional bias, and neural responses to viewing drug-related cues. Here we will use this commonly-prescribed medication as a pharmacological probe of attentional processes related to alcohol use disorder. We hypothesize that acute methylphenidate-associated attentional enhancement will engage compensatory brain mechanisms that will lead to attenuated craving, reduced attentional bias, and modulated neural responses to alcohol cues in young adults with AUD and ADHD. Thirty young adults with AUD and ADHD will be recruited for a double-blind, placebo-controlled, within-subjects experiment to test the effects of an acute 20 mg MPH administration to increase attention on cue-induced alcohol craving [during simultaneous functional magnetic resonance imaging (fMRI) and EEG] and attentional bias. Subjects will also perform computerized tasks of general attention with non-alcohol-related stimuli. The goal of this project is to support the design and funding proposal of a larger study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Methylphenidate Pill

Drug

Single encapsulated pill

Other names: Ritalin

Primary outcomes

  1. Neural responses to cues

    Time frame: 15 minutes

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

  2. Self-reported craving

    Time frame: 15 minutes

    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.

  3. Accuracy on the attentional blink task

    Time frame: 5 minutes

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

Secondary outcomes

  1. Self-reported anxiety

    Time frame: 15 minutes

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

  2. Continuous performance task omission errors

    Time frame: 5 minutes

    Total number of omission errors, indexing sustained attention

  3. Attention network task reaction times

    Time frame: 15 minutes

    response time (RT) difference for no cue vs. central cue ("altering"), RT difference for central cue vs. spatial cue ("orienting"), RT difference for incongruent vs. congruent flankers ("executive control")

  4. Heart rate

    Time frame: 15 minutes

    Heart rate will be recorded during cue-induced craving. We will contrast heart rate during the alcohol images and heart rate during the neutral images.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Methylphenidate and Response to Alcohol Cues (MARA) Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.