Methylphenidate for Alcoholism

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Florida

Must not be taking: Psychoactive drugs

Disqualifiers: Bipolar, Psychotic, Neurological, Seizure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

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 aims to determine if a single dose of methylphenidate (commonly known as Ritalin) can alter how individuals with attention issues respond to alcohol-related cues. Researchers seek to understand whether the medication affects attention and cravings when participants encounter alcohol-related signals. Two groups will participate: one will take methylphenidate first, followed by a placebo, while the other will take a placebo first, followed by methylphenidate. Adults aged 18-25 with both alcohol use disorder (AUD) and attention-deficit/hyperactivity disorder (ADHD), who also have normal vision, might be suitable candidates. Participants will engage in both remote and in-person sessions. As an Early Phase 1 trial, this study focuses on understanding how methylphenidate affects individuals with AUD and ADHD, offering participants the 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 treatment is likely to be safe for humans?

Research has shown that methylphenidate, commonly known as Ritalin, is generally safe when used as directed. It primarily treats ADHD, or Attention Deficit Hyperactivity Disorder. However, mixing it with alcohol can cause problems, such as impaired thinking and risky effects on the heart.

While methylphenidate is safe for many, some misuse it, particularly those with a drinking problem. Studies have highlighted this misuse, indicating that individuals with both ADHD and alcohol use issues need to exercise caution.

In summary, methylphenidate is usually safe when taken correctly, but caution is advised if there is a risk of mixing it with alcohol. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Most treatments for alcoholism, like disulfiram and naltrexone, work by affecting the brain’s reward system or blocking the effects of alcohol. But methylphenidate, commonly known for treating ADHD, is being explored for its potential to reduce alcohol cravings by enhancing dopamine levels in the brain, offering a fresh approach to managing alcoholism. Researchers are excited about methylphenidate because it could help address the underlying neurological pathways involved in addiction, potentially providing more immediate craving relief compared to some traditional treatments. This unique mechanism of action sets it apart from existing options, which mostly focus on deterrence and blocking alcohol effects rather than modulating brain chemistry directly.

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

Research has shown that methylphenidate can aid individuals with substance use issues by enhancing their cognitive clarity and decision-making, crucial for resisting cravings. Studies have found that methylphenidate normalizes brain activity in these areas. In this trial, participants will receive methylphenidate in one of the crossover arms, while the other arm involves a placebo. Although mixing alcohol and stimulants can sometimes be risky, methylphenidate itself does not increase the risk of substance abuse. These findings suggest that methylphenidate might help manage alcohol cravings by improving focus and decision-making. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-25 who have been diagnosed with both Alcohol Use Disorder (AUD) and Attention Deficit Hyperactivity Disorder (ADHD). Participants must speak English fluently and have normal or corrected-to-normal vision.

Inclusion Criteria

Meets DSM-5 criteria for ADHD

Meets DSM-5 criteria for AUD

Fluent in English

Exclusion Criteria

I have high blood pressure readings of 140/90 or higher.

Participant is currently pregnant or trying to become pregnant

I have been diagnosed with bipolar, psychotic, neurological disorders, or substance use disorders other than alcohol use.

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, EEG, and behavioral testing to assess attentional bias and craving responses to alcohol cues.

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, known as Ritalin, changes attention levels and affects responses to alcohol-related cues. It involves one remote session and two in-person sessions using fMRI, EEG, and behavioral testing to compare the effects against a placebo.

How Is the Trial Designed?

Group I: crossover 2: placebo, methylphenidate Experimental Treatment 1 Intervention

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

Group II: crossover 1: methylphenidate, placebo Experimental Treatment 1 Intervention

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

Methylphenidate is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Methylphenidate for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Approved in Canada as Methylphenidate for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Approved in European Union as Methylphenidate for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Methylphenidate and dexmethylphenidate are effective and safe treatments for adults with ADHD, supported by a review of clinical trials, although the evidence is less extensive compared to children and adolescents.

Higher doses of these medications are linked to improved treatment responses, but there are moderate safety concerns, highlighting the importance of individualized treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of methylphenidate and dexmethylphenidate in adults with attention deficit/hyperactivity disorder. Sopko, MA., Caberwal, H., Chavez, B.[2021]

Controlled-delivery methylphenidate (methylphenidate CD) is effective and well tolerated for treating ADHD in children aged 6 and older, showing superior control of symptoms compared to osmotic release methylphenidate during a typical school day.

In clinical trials lasting 3 weeks, methylphenidate CD was found to be more effective than a placebo and equally effective as immediate-release methylphenidate, making it a strong option for managing ADHD symptoms during school hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylphenidate controlled-delivery capsules (EquasymXL, Metadate CD): a review of its use in the treatment of children and adolescents with attention-deficit hyperactivity disorder. Anderson, VR., Keating, GM.[2018]

Dexmethylphenidate, a chirally pure form of methylphenidate, has been shown to effectively manage ADHD in children at half the dose of traditional Ritalin, based on clinical trials involving 684 children.

The drug works by inhibiting the reuptake of norepinephrine and dopamine, and has been found to be well tolerated, with ongoing research to further understand its therapeutic action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride. [2018]

The review highlights the development of various methylphenidate (MPH) formulations for ADHD treatment, including biphasic modified-release options that combine immediate-release and extended-release components for effective symptom management throughout the day.

It also discusses the potential for increased abuse liability when MPH is taken with alcohol, as alcohol can enhance the effects of MPH, emphasizing the need for careful monitoring in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Regimen Individualization for Attention-Deficit/Hyperactivity Disorder: Guidance for Methylphenidate and Dexmethylphenidate Formulations. Patrick, KS., Radke, JL., Raymond, JR., et al.[2020]

In a study involving 308 patients aged 6-17 with ADHD, 65% showed significant improvement after 3 weeks of treatment with Metadate CD, indicating its effectiveness in real-world clinical practice.

The majority of patients (87%) reported satisfaction with Metadate CD, and those switching from other methylphenidate formulations found it to be as effective or better, with adverse events aligning with existing safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A postmarketing clinical experience study of Metadate CD. Dirksen, SJ., D'Imperio, JM., Birdsall, D., et al.[2019]

In a study involving 30 children with ADHD, both the Iranian methylphenidate (Stimdate®) and the original brand (Ritalin®) showed similar effectiveness in reducing ADHD symptoms over a 6-week period.

There were no significant differences in side effects or therapeutic doses between the two medications, indicating that Stimdate® is a safe and effective alternative to Ritalin® for treating ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two brands of Methylphenidate (Stimdate(®) vs. Ritalin(®)) in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized Clinical Trial. Khodadust, N., Jalali, AH., Ahmadzad-Asl, M., et al.[2021]

A case report of a 6-year-old boy with ADHD and autism spectrum disorder revealed that he experienced rare sedation and lethargy after starting a low dose of mixed amphetamine salts, highlighting an unusual adverse effect of this medication.

Despite being a common treatment for ADHD, clinicians should be vigilant in monitoring for unexpected side effects like sedation, especially in patients with coexisting conditions such as autism spectrum disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedation After a Trial of Mixed Amphetamine Salts in a Boy with Attention-Deficit/Hyperactivity Disorder. Al Awami, R., Albanna, A.[2022]

Citations

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

Methylphenidate as a treatment option for substance use ... Methylphenidate has been shown to improve cognitive control and normalize associated brain activation in substance use disorder patients.

2. 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, ...

3. 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 ...

4. 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 ...

5. 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 ...

6. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/c/concertatab.pdf

CONCERTA® DATA SHEET Use with alcohol​​ Alcohol may exacerbate the adverse CNS effects of psychoactive drugs, including methylphenidate. It is therefore advisable for patients to ...

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

Methylphenidate abuse and misuse in patients affected ... The most important SUD associated with misuse of methylphenidate is alcohol use disorder, reported in eight of the twelve studies (26–29, 31, 33, 34, 36) ...