Methylphenidate and Response to Alcohol Cues

January 9, 2026 updated by: University of Florida

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crossover 1: methylphenidate, placebo
methylphenidate (single dose, oral, 20 mg, immediate release) followed by placebo (single dose, oral)
Drug: Methylphenidate Pill
Encapsulated methylphenidate
Other: Placebo Pill
Encapsulated placebo
Experimental: Crossover 2: placebo, methylphenidate
placebo (single dose, oral) followed by methylphenidate (single dose, oral, 20 mg, immediate release)
Drug: Methylphenidate Pill
Encapsulated methylphenidate
Other: Placebo Pill
Encapsulated placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202500591
  • R01AA032400 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The final dataset will include brain imaging, behavioral, and self-report data obtained from task (viewing of alcohol pictorial cues), self-ratings of craving during the task scan, computerized tasks of attention, and interview and survey measures of mental health and substance use. De-identified individual-participant level (IPD) raw data will be shared. Appropriate measures such as de-facing T1 anatomical MRI images using software for this purpose (e.g., mri_deface) will be used for data de-identification prior to sharing, and informed consent forms will reflect those plans.

IPD Sharing Time Frame

2028-2033

IPD Sharing Access Criteria

Scientists with access to the NIH-managed data repository will have access to the IPD.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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