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

30 Participants Needed

Trial Summary

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 methylphenidate generally safe for humans?

Methylphenidate, used in various forms like Ritalin and Concerta, is generally well tolerated and considered safe for treating ADHD in both children and adults. Some common side effects include insomnia, irritability, and loss of appetite, but serious side effects are rare. It has been tested in clinical trials and found to be effective and well tolerated in both children and adults. ^{1 2 3 4 5}

How does the drug methylphenidate differ from other treatments for alcoholism?

Methylphenidate is unique in treating alcoholism as it is primarily known for managing ADHD by increasing dopamine and norepinephrine levels in the brain, which may help address the underlying neurochemical imbalances associated with alcohol addiction. This approach is novel compared to traditional alcoholism treatments that often focus on behavioral therapy or medications targeting alcohol metabolism. ^{2 4 5 6 7}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A postmarketing clinical experience study of Metadate CD. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Sedation After a Trial of Mixed Amphetamine Salts in a Boy with Attention-Deficit/Hyperactivity Disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The safety and efficacy of methylphenidate and dexmethylphenidate in adults with attention deficit/hyperactivity disorder. [2021]

5. Switzerland 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Drug Regimen Individualization for Attention-Deficit/Hyperactivity Disorder: Guidance for Methylphenidate and Dexmethylphenidate Formulations. [2020]

7. Netherlands 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. [2021]