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Tolcapone for Alcoholism and ADHD

Phase 2
Recruiting
Led By Joseph P Schacht, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-65.
Currently not taking any medication for AUD or ADHD.
Must not have
Females of childbearing potential who are pregnant (by plasma HCG), nursing, or who are not using a reliable form of contraception
Current DSM-5 psychotic, mood, anxiety, obsessive-compulsive, trauma-related, or eating disorder, as assessed by SCID-5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after laboratory alcohol administration on day 1 of each medication period. each medication period is 8 days long.

Summary

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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Tolcapone can cause liver problems which will be monitored closely. Other possible side effects include diarrhea, nausea, sleepiness or trouble sleeping. Some people might experience confusion or hallucinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 65 years old.
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I am not on medication for alcohol use disorder or ADHD.
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I am not on medication for alcohol use disorder or ADHD.
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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, and I use reliable contraception.
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I have been diagnosed with a mental health disorder like schizophrenia, depression, or an eating disorder.
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I am not having thoughts of harming myself or others.
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I have or had liver disease, or my liver tests are higher than normal.
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I am currently taking medication for mental health issues.
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I have had a neurological disease or head injury that caused me to be unconscious for more than 2 minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after laboratory alcohol administration on day 1 of each medication period. each medication period is 8 days long.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after laboratory alcohol administration on day 1 of each medication period. each medication period is 8 days long. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in alcohol cue-elicited brain activation (fMRI) between medication periods
Change in alcohol-induced stimulation between medication periods
Change in cognitive-control-associated brain activation (fMRI) between medication periods
+3 more

Trial Design

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Tolcapone
2014
Completed Phase 2
~630

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for alcoholism include naltrexone, disulfiram, acamprosate, and gabapentin. Naltrexone works by blocking opioid receptors, reducing the rewarding effects of alcohol and decreasing cravings. Disulfiram inhibits the enzyme acetaldehyde dehydrogenase, causing unpleasant symptoms when alcohol is consumed, thus deterring drinking. Acamprosate modulates glutamate neurotransmission, helping to restore the balance of neurotransmitters disrupted by chronic alcohol use. Gabapentin, an anticonvulsant, is thought to reduce alcohol cravings and withdrawal symptoms by modulating GABA and glutamate systems. These mechanisms are crucial as they target different aspects of alcohol dependence, offering multiple pathways to support recovery. Tolcapone, a COMT inhibitor, is being studied for its potential to affect alcohol response and decision-making, which could provide another therapeutic avenue by influencing dopamine metabolism.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,102 Total Patients Enrolled
12 Trials studying Alcoholism
1,654 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
838 Previous Clinical Trials
1,083,006 Total Patients Enrolled
459 Trials studying Alcoholism
824,022 Patients Enrolled for Alcoholism
Joseph P Schacht, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
4 Previous Clinical Trials
505 Total Patients Enrolled
3 Trials studying Alcoholism
385 Patients Enrolled for Alcoholism

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03904498 — Phase 2
Alcoholism Research Study Groups: Placebo then Tolcapone, Tolcapone then Placebo
Alcoholism Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03904498 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03904498 — Phase 2
~3 spots leftby Mar 2025