Tolcapone for Alcoholism and ADHD
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?
Is the drug Tolcapone a promising treatment for Alcoholism and ADHD?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Assessment
Initial assessment visit to evaluate baseline characteristics and eligibility
Treatment Period 1
Participants receive either placebo or tolcapone for 8 days, including MRI scans and alcohol administration
Washout
A washout period between medication periods to clear the effects of the first treatment
Treatment Period 2
Participants receive the alternate treatment (tolcapone or placebo) for 8 days, including MRI scans and alcohol administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Tolcapone
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator