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Methylphenidate and Response to Alcohol Cues

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07306078
Enrollment
50
Registered
2025-12-29
Start date
2026-10-01
Completion date
2028-08-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

fMRI, methylphenidate, ritalin, attention, alcohol

Brief summary

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

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.

Interventions

Encapsulated methylphenidate

OTHERPlacebo Pill

Encapsulated placebo

Sponsors

University of Florida
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neural responses to cues15 minutesWhole-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

MeasureTime frameDescription
Self-reported craving15 minutesCraving 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026