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NCT Number: NCT07306078

Methylphenidate and Response to Alcohol Cues

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 neural and craving responses to alcohol cues through fMRI and behavioral testing. Participants will be involved in one remote and two in-person sessions.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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 alcohol misuse 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. This study will use this commonly-prescribed medication as a pharmacological probe of attentional processes related to alcohol use disorder. It is hypothesized 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. Fifty young adults reporting hazardous alcohol use will be recruited for a double-blind, placebo-controlled, within-subjects experiment to test the effects of an acute 20 mg methylphenidate administration to increase attention on cue-induced alcohol craving [during functional magnetic resonance imaging (fMRI)] and attentional bias. Subjects will also perform computerized tasks of general attention with non-alcohol-related stimuli.

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 Alcohol Use Disorder -OR- score on the Alcohol Use Disorders Identification Test (AUDIT) of >=8
  • Fluent in English
  • Normal or corrected to normal vision

Exclusion criteria

  • Meets DSM-5 criteria for psychotic disorders, neurological disorders, or substance use disorders other than Alcohol Use Disorder.
  • 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 Alcohol Use Disorder).
  • 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

Encapsulated methylphenidate

Placebo pill

Other

Encapsulated placebo

Primary outcomes

  1. Neural responses to cues

    Time frame: 15 minutes

    Whole-brain cue-elicited fMRI responses will be examined by contrasting activation following alcohol images with brain activation following neutral images. Regions-of-interest analysis will focus on anterior cingulate cortex, dorsal striatum, ventral striatum, and amygdala.

Secondary outcomes

  1. Self-reported craving

    Time frame: 15 minutes

    Craving following presentation of alcohol and neutral images will be reported using 0-10 visual analog scales. Differences in craving following the alcohol images and craving following the neutral images will be tested.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Attentional Ability and Resilience to Alcohol Use Disorder: Neurocognitive Mechanisms: Protocol Two

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2025
Registry last updated
Jan 13, 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.

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