Methylphenidate and Response to Alcohol Cues Pilot Study

February 6, 2026 updated by: University of Florida

Methylphenidate and Response to Alcohol Cues (MARA) 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: crossover 1: methylphenidate, placebo
methylphenidate (single dose, oral, 20 mg, immediate release) followed by placebo (single dose, oral)
Drug: Methylphenidate Pill
Single encapsulated pill
Other Names:
  • Ritalin
Other: crossover 2: placebo, methylphenidate
placebo (single dose, oral) followed by methylphenidate (single dose, oral, 20 mg, immediate release)
Drug: Methylphenidate Pill
Single encapsulated pill
Other Names:
  • Ritalin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
15 minutes
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.
15 minutes
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.
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
15 minutes
Continuous performance task omission errors
Time Frame: 5 minutes
Total number of omission errors, indexing sustained attention
5 minutes
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")
15 minutes
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.
15 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB202301428

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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