Methylphenidate for Alcoholism

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Psychoactive drugs

Disqualifiers: Psychotic, Neurological, Seizure, Liver, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how methylphenidate, also known as Ritalin, affects attention and cravings when individuals with alcohol use disorder encounter alcohol-related cues. Researchers aim to determine if a single dose of methylphenidate alters brain activity and cravings compared to a placebo, using brain scans and behavior tests. Individuals diagnosed with alcohol use disorder or those with a high score on an alcohol use test, who can speak English and have normal vision, might qualify for this trial. Participants will engage in one remote session and two in-person sessions. As an Early Phase 1 trial, this research seeks to understand how methylphenidate functions in people with alcohol use disorder, providing a unique opportunity to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who routinely use psychoactive drugs or medications, except for non-dependent marijuana or nicotine use.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methylphenidate, commonly known as Ritalin, is generally safe. Doctors often prescribe it for ADHD (attention deficit hyperactivity disorder), and it carries a low risk of addiction because it works slowly and wears off gradually. One study found that people taking it for ADHD did not face a higher risk of substance abuse.

However, some possible side effects exist. Reports include stomach issues, heart problems, and episodes of psychosis (a mental condition where someone loses touch with reality) when the drug is misused. It's important to note that these effects occurred in cases of misuse, differing from the controlled use in a study.

Overall, methylphenidate is well-tolerated when used correctly, but being informed about its potential effects is wise. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for alcoholism focus on behavioral therapy, counseling, or medications that target cravings and withdrawal symptoms, like naltrexone and acamprosate. But methylphenidate, a medication traditionally used for ADHD, is being explored for its potential to improve attention and impulse control in alcohol use disorder. Researchers are excited because methylphenidate may help reduce the impulsivity and inattention that often accompany alcoholism, offering a novel approach that targets the brain's dopamine pathways. Unlike current medications, which primarily manage cravings, methylphenidate could address some underlying behavioral aspects of alcoholism, potentially leading to better long-term outcomes.

What evidence suggests that methylphenidate might be an effective treatment for alcoholism?

Research shows that methylphenidate, also known as Ritalin, can help people think more clearly and control their actions better. Some studies suggest it can normalize brain activity in individuals with substance use problems, potentially aiding those struggling with alcoholism. In this trial, participants will receive methylphenidate in one of the crossover arms. While direct evidence of methylphenidate treating alcoholism is limited, it might help by reducing cravings and impulsive decisions related to alcohol use. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-25 with Alcohol Use Disorder or an AUDIT score of >=8, and normal vision. It's not for those with psychotic/neurological disorders, other substance use disorders (except non-dependent marijuana/nicotine), high blood pressure, pregnancy, routine psychoactive drug use, contraindications to MRI or methylphenidate, seizures or liver disease.

Inclusion Criteria

Fluent in English

Meets DSM-5 criteria for Alcohol Use Disorder -OR- score on the Alcohol Use Disorders Identification Test (AUDIT) of >=8

I am between 18 and 25 years old.

Exclusion Criteria

Meets DSM-5 criteria for psychotic disorders, neurological disorders, or substance use disorders other than Alcohol Use Disorder

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of methylphenidate or placebo and undergo fMRI and behavioral testing

1 week

1 remote session, 2 in-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Methylphenidate

Trial Overview

The study tests if a single dose of methylphenidate (Ritalin) changes attention levels and affects responses to alcohol cues compared to a placebo. Participants will undergo fMRI scans and behavioral testing in one remote and two in-person sessions to observe neural and craving responses.

How Is the Trial Designed?

Group I: Crossover 2: placebo, methylphenidate Experimental Treatment 2 Interventions

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

Group II: Crossover 1: methylphenidate, placebo Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10435872/

Methylphenidate as a treatment option for substance use ...

In addition, methylphenidate has been shown to improve cognitive control and normalize associated brain activation in substance use disorder patients and ...

2.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/2806881

Association Between Stimulant Treatment and Substance ...

This study found no evidence that stimulant treatment, predominantly prescribed in childhood and adolescence, protects against or increases risk of later ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0149763421003092

Alcohol use disorders and ADHD

Impulsive decisions and a maladaptive reward system make individuals with ADHD vulnerable for alcohol use and up to 43 % develop an AUD; in adults with AUD, ...

4.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1508732/full

Methylphenidate abuse and misuse in patients affected ...

Adverse outcomes included heightened risk of gastrointestinal events (N=201/1551 individuals), cardiovascular events (N=108/1551 individuals), psychosis (N=69/ ...

5.

americanaddictioncenters.org

americanaddictioncenters.org/alcohol/mixing-stimulants

Mixing Alcohol and Stimulants: Risks, Effects, and Dangers

The concurrent use of alcohol with psychostimulant substances can lead to cognitive impairment, can have dangerous cardiovascular effects, and can potentiate ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4147667/

Stimulant ADHD medication and risk for substance abuse

ADHD medication was not associated with increased rate of substance abuse. Actually, the rate during 2009 was 31% lower among those prescribed ADHD medication ...