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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes after laboratory alcohol administration on day 1 of each medication period. each medication period is 8 days long.
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.
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.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.I am not having thoughts of harming myself or others.You have a diagnosis of a substance use disorder other than nicotine.I have or had liver disease, or my liver tests are higher than normal.You currently have alcohol use disorder and attention-deficit/hyperactivity disorder, as determined by specific assessments.You live within 50 miles of the study site.\nI am not on medication for alcohol use disorder or ADHD.You are not currently receiving treatment for or interested in getting treatment for alcohol use disorder (AUD) or attention-deficit/hyperactivity disorder (ADHD).I am not on medication for alcohol use disorder or ADHD.You have metal in your body, as shown by a metal screening test or your own report.You have had medical issues in the past related to drinking alcohol, like stomach bleeding, pancreatitis, or ulcers.I have no major health issues like heart, kidney, stomach, or hormone problems.I am between 21 and 65 years old.You have used drugs or other substances that affect the mind, except for nicotine, in the past 30 days.You are extremely afraid of small spaces or you are very overweight and cannot fit in the MRI scanner.I am currently taking medication for mental health issues.I have had a neurological disease or head injury that caused me to be unconscious for more than 2 minutes.You don't have a stable place to live.You have experienced serious problems when stopping drinking alcohol, such as seizures or delirium tremens.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo then Tolcapone
- Group 2: Tolcapone then Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.