62 Participants Needed

Tolcapone for Alcoholism and ADHD

JP
KR
Overseen ByKristen Raymond, BA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests tolcapone to see if it helps people with both alcohol use issues and attention problems. The study focuses on people with both AUD and ADHD. Tolcapone works by affecting brain chemicals related to mood and behavior. Initially used for Parkinson's disease, tolcapone might be considered for ADHD treatment.

Do I have to stop taking my current medications to join the trial?

Yes, you must not be taking any medication for AUD, ADHD, or any psychoactive medication to participate in this trial.

Will I have to stop taking my current medications?

Yes, you must not be taking any medication for Alcohol Use Disorder (AUD) or Attention-Deficit/Hyperactivity Disorder (ADHD) to participate in this trial.

What data supports the idea that Tolcapone for Alcoholism and ADHD is an effective drug?

The available research shows that Tolcapone has been studied primarily for its use in treating Parkinson's disease, not Alcoholism or ADHD. The studies focus on its ability to help manage symptoms in Parkinson's patients by improving 'on' time and reducing 'off' time when used with other medications. There is no data provided that supports its effectiveness for Alcoholism or ADHD.12345

What safety data exists for Tolcapone in treating alcoholism and ADHD?

The provided research does not contain safety data for Tolcapone or its other names (Tasmar, Tolcapon, etc.) in the treatment of alcoholism and ADHD. The studies focus on other medications like nalmefene and naltrexone for alcohol dependence. Further research specifically on Tolcapone is needed to answer this question.678910

Is tolcapone safe for use in humans?

In a study with healthy volunteers, tolcapone did not cause any serious side effects or abnormal lab results, suggesting it is generally safe when used with tolbutamide.1112131415

Is the drug Tolcapone a promising treatment for Alcoholism and ADHD?

Tolcapone shows potential as a treatment for Alcohol Use Disorder, especially in individuals who are physically dependent on alcohol, as it may help reduce alcohol consumption. However, its effectiveness for ADHD is not discussed in the provided research.1451617

How is the drug tolcapone unique in treating alcoholism and ADHD?

Tolcapone is unique because it is a catechol-O-methyltransferase (COMT) inhibitor, originally used for Parkinson's disease, and it shows promise in treating alcohol use disorder by potentially improving cognitive effects associated with alcohol dependence. Its use in ADHD and alcoholism is novel, as it targets different mechanisms compared to standard treatments.1451617

Research Team

JP

Joseph P Schacht, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults aged 21-65 who meet the criteria for both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD), but are not currently seeking treatment or taking medication for these conditions. Participants must live within 50 miles of the study site, be able to understand consent forms, and not have any severe medical issues or metal in their body.

Inclusion Criteria

Currently not engaged in, and does not want treatment for, AUD or ADHD
You currently meet the criteria for Alcohol Use Disorder and Attention-Deficit/Hyperactivity Disorder according to specific diagnostic assessments.
I am between 21 and 65 years old.
See 9 more

Exclusion Criteria

Current charges pending for a violent crime (not including DUI-related offenses)
I am not pregnant, nursing, and I use reliable contraception.
I have been diagnosed with a mental health disorder like schizophrenia, depression, or an eating disorder.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Assessment

Initial assessment visit to evaluate baseline characteristics and eligibility

1 week
1 visit (in-person)

Treatment Period 1

Participants receive either placebo or tolcapone for 8 days, including MRI scans and alcohol administration

2 weeks
3 visits (in-person)

Washout

A washout period between medication periods to clear the effects of the first treatment

1 week

Treatment Period 2

Participants receive the alternate treatment (tolcapone or placebo) for 8 days, including MRI scans and alcohol administration

2 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Tolcapone
Trial OverviewThe study tests if tolcapone, a drug that affects brain chemistry, changes how people with AUD/ADHD respond to alcohol, make decisions, react to alcohol cues in the brain, control impulses and focus attention compared to a placebo. It also looks at whether it affects their drinking habits.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Tolcapone then PlaceboExperimental Treatment2 Interventions
Participants in this arm will receive tolcapone during the first medication period (1 capsule containing 200 mg tolcapone on study days 1 and 2; 3 capsules containing a total of 600 mg tolcapone on study days 3-8), and placebo during the second medication period (1 capsule on study days 1 and 2; 3 capsules on study days 3-8).
Group II: Placebo then TolcaponeExperimental Treatment2 Interventions
Participants in this arm will receive placebo during the first medication period (1 capsule on study days 1 and 2; 3 capsules on study days 3-8), and tolcapone during the second medication period (1 capsule containing 200 mg tolcapone on study days 1 and 2; 3 capsules containing a total of 600 mg tolcapone on study days 3-8).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Findings from Research

Tolcapone is an effective adjunct treatment for Parkinson's disease, significantly reducing 'off' time and improving symptoms in patients who do not respond to other therapies, with a recommended dosage of 100 mg three times daily.
However, tolcapone carries risks of serious side effects, including potential liver damage, necessitating regular liver function tests and careful monitoring of patients during treatment.
Tolcapone: a novel approach to Parkinson's disease.Micek, ST., Ernst, ME.[2019]
In two large studies involving 379 patients with Parkinson's disease, tolcapone at doses of 300 and 600 mg/day significantly improved 'on' time and reduced 'off' time, indicating better motor function while on levodopa treatment.
While tolcapone was effective in enhancing motor control, the most common side effect was increased dyskinesia, although hallucinations were rare, suggesting a need for careful monitoring of patients.
Highlights of the North American and European experiences.Goetz, CG.[2019]
Tolcapone significantly increased the plasma levels of levodopa in healthy volunteers, effectively doubling the area under the plasma concentration-time curve and extending the half-life of levodopa, particularly at a 200 mg dose.
The study found that tolcapone was well-tolerated with only minor adverse effects across all tested doses, suggesting it is a safe add-on therapy for enhancing levodopa efficacy in Parkinson's disease treatment.
Effect of tolcapone on plasma levodopa concentrations after coadministration with levodopa/carbidopa to healthy volunteers.Sêdek, G., Jorga, K., Schmitt, M., et al.[2019]

References

Tolcapone: a novel approach to Parkinson's disease. [2019]
Highlights of the North American and European experiences. [2019]
Effect of tolcapone on plasma levodopa concentrations after coadministration with levodopa/carbidopa to healthy volunteers. [2019]
Integrated pharmacokinetics and pharmacodynamics of the novel catechol-O-methyltransferase inhibitor tolcapone during first administration to humans. [2018]
Tolcapone: new drug. In Parkinson's disease: unacceptable risk of severe hepatitis. [2013]
Risks and Benefits of Nalmefene in the Treatment of Adult Alcohol Dependence: A Systematic Literature Review and Meta-Analysis of Published and Unpublished Double-Blind Randomized Controlled Trials. [2018]
Safety and tolerability of as-needed nalmefene in the treatment of alcohol dependence: results from the Phase III clinical programme. [2015]
Pharmacotherapy of alcoholism - an update on approved and off-label medications. [2018]
Tolerability of naltrexone in treating older, alcohol-dependent patients. [2016]
Nalmefene, Given as Needed, in the Routine Treatment of Patients with Alcohol Dependence: An Interventional, Open-Label Study in Primary Care. [2019]
Lack of interaction between tolcapone and tolbutamide in healthy volunteers. [2019]
Eszopiclone: an update on its use in insomnia. [2017]
13.United Statespubmed.ncbi.nlm.nih.gov
Estimating the In Vivo Function of CYP2D6 Alleles through Population Pharmacokinetic Modeling of Brexpiprazole. [2023]
An assessment of the efficacy and safety of eszopiclone in the treatment of transient insomnia in healthy adults. [2022]
Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration. [2022]
Pharmacokinetics and pharmacodynamics after oral and intravenous administration of tolcapone, a novel adjunct to Parkinson's disease therapy. [2019]
Catechol-O-Methyltransferase inhibition and alcohol use disorder: Evaluating the efficacy of tolcapone in ethanol-dependent rats. [2023]