Methylphenidate and Response to Alcohol Cues

NCT ID: NCT06063200

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2025-07-01

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 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.

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.

Conditions

Alcohol Use Disorder; Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

crossover 1: methylphenidate, placebo

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

Group Type: OTHER

Methylphenidate Pill

Intervention Type: DRUG

Single encapsulated pill

crossover 2: placebo, methylphenidate

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

Group Type: OTHER

Methylphenidate Pill

Intervention Type: DRUG

Single encapsulated pill

Interventions

Methylphenidate Pill

Single encapsulated pill

Intervention Type: DRUG

Other Intervention Names

Ritalin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202301428

Identifier Type: -

Identifier Source: org_study_id