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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.
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.
Awards & highlights
Study Summary
This trial will test whether the drug tolcapone can help people who drink too much alcohol by affecting brain function.
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.Check my eligibility
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.See study design
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.
Select...
I am not on medication for alcohol use disorder or ADHD.
Select...
I am not on medication for alcohol use disorder or ADHD.
Select...
I am between 21 and 65 years old.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,464 Total Patients Enrolled
12 Trials studying Alcoholism
1,654 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
802 Previous Clinical Trials
1,365,383 Total Patients Enrolled
424 Trials studying Alcoholism
985,806 Patients Enrolled for Alcoholism
Joseph P Schacht, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
3 Previous Clinical Trials
385 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for this trial?
"Affirmative. The clinicaltrials.gov website attests to this trial's ongoing recruitment efforts, which began on August 16th 2021 and were most recently updated on August 10th 2022. 62 individuals are being sought at 1 medical centre for this research endeavour."
Answered by AI
How many participants are actively engaging in this experiment?
"Indeed, as shown on clinicaltrials.gov, this research trial is currently recruiting volunteers. The protocol was first announced in August 2021 and the latest version was released in August 2022; 62 individuals are being sought at a single testing centre."
Answered by AI
Has Tolcapone met the criteria set by the FDA for widespread use?
"Our team at Power assigned Tolcapone a score of 2 on the safety scale due to existing clinical data that suggests it is safe, but no evidence yet indicates its efficacy."
Answered by AI
What are the criteria for enrollment in this experiment?
"This clinical trial is focusing on 62 individuals diagnosed with attention deficit disorder, aged between 21 and 65. For admission to the study, participants must meet certain prerequisites such as not being engaged in treatment for AUD or ADHD, nor taking any medication related to these conditions."
Answered by AI
Are participants aged 45 or younger eligible for enrollment in this research?
"This medical trial is open to participants of legal age (21+) and who have yet to reach the retirement years (65-)."
Answered by AI
What precedent exists for the use of Tolcapone in clinical studies?
"Currently, there are 4 ongoing trials for Tolcapone; none of them have reached Phase 3. Berkeley, California is the primary test site location but other clinical trial sites around the world are also testing this drug."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
New York
Pennsylvania
Other
How old are they?
18 - 65
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
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