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Methylphenidate and Response to Alcohol Cues

NCT ID: NCT07306078

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-31

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Use Disorder

Keywords

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fMRI methylphenidate ritalin attention alcohol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Crossover 2: placebo, methylphenidate

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

Group Type EXPERIMENTAL

Methylphenidate Pill

Intervention Type DRUG

Encapsulated methylphenidate

Placebo Pill

Intervention Type OTHER

Encapsulated placebo

Crossover 1: methylphenidate, placebo

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

Group Type EXPERIMENTAL

Methylphenidate Pill

Intervention Type DRUG

Encapsulated methylphenidate

Placebo Pill

Intervention Type OTHER

Encapsulated placebo

Interventions

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Methylphenidate Pill

Encapsulated methylphenidate

Intervention Type DRUG

Placebo Pill

Encapsulated placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Facility Contacts

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Amanda Elton, PhD

Role: primary

Other Identifiers

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IRB202500591

Identifier Type: -

Identifier Source: org_study_id