NCT07306078

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
23mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Apr 2028

First Submitted

Initial submission to the registry

December 3, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

January 13, 2026

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

December 3, 2025

Last Update Submit

January 9, 2026

Conditions

Alcohol Use Disorder

Keywords

fMRImethylphenidateritalinattentionalcohol

Outcome Measures

Primary Outcomes (1)

  • Neural responses to cues

    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 Outcomes (1)

  • Self-reported craving

    15 minutes

Study Arms (2)

Crossover 1: methylphenidate, placebo

EXPERIMENTAL

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

Drug: Methylphenidate PillOther: Placebo Pill

Crossover 2: placebo, methylphenidate

EXPERIMENTAL

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

Drug: Methylphenidate PillOther: Placebo Pill

Interventions

Methylphenidate PillDRUG

Encapsulated methylphenidate

Crossover 1: methylphenidate, placeboCrossover 2: placebo, methylphenidate
Placebo PillOTHER

Encapsulated placebo

Crossover 1: methylphenidate, placeboCrossover 2: placebo, methylphenidate

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 29, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

January 13, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR
Time Frame
2028-2033
Access Criteria
Scientists with access to the NIH-managed data repository will have access to the IPD.

Locations

US(1)