Alcohol Use DisorderEarly Phase 1NCT06063200
Methylphenidate and Response to Alcohol Cues Pilot Study
A Early Phase 1 study testing Methylphenidate Pill in people with Alcohol Use Disorder and Attention Deficit Hyperactivity Disorder, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to 1 Jul 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Methylphenidate Pill
- Keywords
- fMRI, EEG
- Medical subject headings
- Alcoholism, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate PillDrug
Also called Ritalin
Single encapsulated pill
| Study group | Role | What they receive |
|---|---|---|
| crossover 1: methylphenidate, placebo | Other | methylphenidate (single dose, oral, 20 mg, immediate release) followed by placebo (single dose, oral) Receives: Drug: Methylphenidate Pill |
| crossover 2: placebo, methylphenidate | Other | placebo (single dose, oral) followed by methylphenidate (single dose, oral, 20 mg, immediate release) Receives: Drug: Methylphenidate Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural responses to cues
Cue-elicited EEG and fMRI responses. We will contrast brain activation following alcohol images with brain activation following neutral images.
Measured: 15 minutes
Self-reported craving
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.
Measured: 15 minutes
Accuracy on the attentional blink task
We will contrast accuracy during alcohol distractor trials with neutral distractor trials for "lags" of 8 versus 2 images following the distractor.
Measured: 5 minutes
Secondary outcomes (4)
Self-reported anxiety
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.
Measured: 15 minutes
Continuous performance task omission errors
Total number of omission errors, indexing sustained attention
Measured: 5 minutes
Attention network task reaction times
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")
Measured: 15 minutes
Heart rate
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start20 Mar 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063200
- Sponsor's protocol ID
- IRB202301428
- Status last verified
- Jul 2025
- First submitted
- 26 Sep 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidate and Response to Alcohol Cues (MARA) Pilot Study
- ClinicalTrials.gov ID
- NCT06063200
- Acronym / sponsor ID
- IRB202301428
- Keywords
- fMRI, EEG
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crossover 1: methylphenidate, placebo | Other | Drug: Methylphenidate Pillmethylphenidate (single dose, oral, 20 mg, immediate release) followed by placebo (single dose, oral) |
| crossover 2: placebo, methylphenidate | Other | Drug: Methylphenidate Pillplacebo (single dose, oral) followed by methylphenidate (single dose, oral, 20 mg, immediate release) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate PillAlso: RitalinSingle encapsulated pill | Drug | crossover 1: methylphenidate, placebo, crossover 2: placebo, methylphenidate |
Primary outcome
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.
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.
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.
4 secondary outcomes
Self-reported anxiety
Time frame: 15 minutes
Continuous performance task omission errors
Time frame: 5 minutes
Attention network task reaction times
Time frame: 15 minutes
Heart rate
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methylphenidate Pill in people with Alcohol Use Disorder and Attention Deficit Hyperactivity Disorder, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural responses to cues (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.