Alcohol AbusePhase 2NCT02740582
Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users
A Phase 2 study testing Tolcapone in people with Alcohol Abuse and Impulsive Behavior, run by Jennifer Mitchell at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effects of tolcapone on decision making and alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol drinkers. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Impulsive Behavior
- What is being tested?
- Tolcapone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2016to 1 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers who are 21-40 years of age
- If female, 10 or more alcoholic drinks must be consumed weekly.
- If male, 14 or more alcoholic drinks must be consumed weekly.
- Meets DSM-V criteria for Alcohol Use Disorder (AUD).
- If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
- Ability to read and speak English.
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- High school graduate.
- Able and willing to provide an informed consent.
- Able to understand and follow the instructions of the investigator, including the delayed discounting tasks. Residing within 5 miles of the study site.
Who cannot join
- Positive urine drug screen (except marijuana).
- Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills. or other psychoactive drugs within 2 weeks of the start of the study (except marijuana).
- Marijuana use more than 3 times/week.
- Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
- Currently trying to quit alcohol use.
- History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.).
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- Two SGPT/ALT or SGOT/AST values greater than the upper limit of normal.
- Unable to pass the Standard Field Sobriety Test in a sober state (BAC = 0.00).
- BAC level >0.05% at the beginning of screening visit (within margin of error of detection).
- Regular use of any of the drugs on the tolcapone contraindications list OR within 2 weeks of drug administration.
- Severe low blood (< 90/50) pressure or uncontrolled high blood pressure (>160/100). Allergy or intolerance to tolcapone.
- Subject has received an investigational drug within 30 days of the screening visit.
- Subject is considered unsuitable for the study in the opinion of the investigator or clinician for any other reason (such as an Axis II personality disorder that makes the subject unable to comply with study instructions, per the Clinician's judgement.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Berkeley
Berkeley, California, 94704
University of California, San Francisco
San Francisco, California, 94109
About this study
Official title: Effects of Tolcapone on Decision Making and Alcohol Intake Using a Laboratory Bar in Moderate to Heavy Social Drinkers
The purpose of this study is to determine the effects of tolcapone on decision making and alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol drinkers.
Read the detailed description
The study is a 7-session, double blind, placebo-controlled crossover study of the effects of tolcapone, the COMT inhibitor, on decision making and alcohol intake using a laboratory bar in moderate to heavy social alcohol drinkers. Subjects will be moderate to heavy social users of alcohol, defined as at least 10 standard drinks per week for women and at least 14 standard drinks per week for men. There will be one screening session followed by six additional visits including 2 laboratory bar sessions. On each study drug administration day, subjects will come in to the clinic for a medication dispensation visit and instructions on when and how to take the study drug for the remainder of the study. Study drug bottles will be equipped with MEMS caps to ensure compliance. After 5 days of drug administration, subjects will return to the clinic for a laboratory bar. This session will consist of administration of a standardized laboratory bar paradigm and a series of computerized and written decision-making tasks. Subjects will then be crossed over and complete the same series of study visits on the alternate study drug.
- Conditions
- Alcohol Abuse, Impulsive Behavior
- Being tested
- Tolcapone, Placebo
- Medical subject headings
- Alcoholism, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolcaponeDrug
Also called Tasmar
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tolcapone First, then Placebo | Experimental | Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID Receives: Drug: Tolcapone; Drug: Placebo |
| Placebo First, then Tolcapone | Placebo comparator | Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID Receives: Drug: Tolcapone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinks Consumed in a Laboratory Bar Session
Number of drinks consumed in a laboratory bar session (out of a maximum of 4 drinks available) following either placebo or tolcapone administration.
Measured: A laboratory bar session is 1 hour long
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start1 Oct 2016
- Primary completion1 Sep 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Mitchell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Mitchell, University of California, San Francisco
- Investigators
- Jennifer Mitchell, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740582
- Sponsor's protocol ID
- Tolcapone Lab Bar
- Status last verified
- Sep 2020
- First submitted
- 12 Apr 2016
- Last updated
- 21 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Coker AR, Weinstein DN, Vega TA, Miller CS, Kayser AS, Mitchell JM. The catechol-O-methyltransferase inhibitor tolcapone modulates alcohol consumption and impulsive choice in alcohol use disorder. Psychopharmacology (Berl). 2020 Oct;237(10):3139-3148. doi: 10.1007/s00213-020-05599-5. Epub 2020 Jul 2.
PubMed 32617646
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tolcapone on Decision Making and Alcohol Intake Using a Laboratory Bar in Moderate to Heavy Social Drinkers
- ClinicalTrials.gov ID
- NCT02740582
- Acronym / sponsor ID
- Tolcapone Lab Bar
- Conditions
- Alcohol Abuse, Impulsive Behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jennifer MitchellUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 21 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of tolcapone on decision making and alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol drinkers.
Detailed description
The study is a 7-session, double blind, placebo-controlled crossover study of the effects of tolcapone, the COMT inhibitor, on decision making and alcohol intake using a laboratory bar in moderate to heavy social alcohol drinkers. Subjects will be moderate to heavy social users of alcohol, defined as at least 10 standard drinks per week for women and at least 14 standard drinks per week for men. There will be one screening session followed by six additional visits including 2 laboratory bar sessions. On each study drug administration day, subjects will come in to the clinic for a medication dispensation visit and instructions on when and how to take the study drug for the remainder of the study. Study drug bottles will be equipped with MEMS caps to ensure compliance. After 5 days of drug administration, subjects will return to the clinic for a laboratory bar. This session will consist of administration of a standardized laboratory bar paradigm and a series of computerized and written decision-making tasks. Subjects will then be crossed over and complete the same series of study visits on the alternate study drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolcapone First, then Placebo | Experimental | Drug: Tolcapone, Drug: PlaceboTolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID |
| Placebo First, then Tolcapone | Placebo comparator | Drug: Tolcapone, Drug: PlaceboPlacebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy volunteers who are 21-40 years of age
- If female, 10 or more alcoholic drinks must be consumed weekly.
- If male, 14 or more alcoholic drinks must be consumed weekly.
- Meets DSM-V criteria for Alcohol Use Disorder (AUD).
- If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
Key exclusion criteria (13 listed)
- Positive urine drug screen (except marijuana).
- Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills. or other psychoactive drugs within 2 weeks of the start of the study (except marijuana).
- Marijuana use more than 3 times/week.
- Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
- Currently trying to quit alcohol use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolcaponeAlso: Tasmar | Drug | Placebo First, then Tolcapone, Tolcapone First, then Placebo |
| Placebo | Drug | Placebo First, then Tolcapone, Tolcapone First, then Placebo |
Primary outcome
Number of Drinks Consumed in a Laboratory Bar Session
Time frame: A laboratory bar session is 1 hour long
Number of drinks consumed in a laboratory bar session (out of a maximum of 4 drinks available) following either placebo or tolcapone administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32617646Coker AR, Weinstein DN, Vega TA, Miller CS, Kayser AS, Mitchell JM. The catechol-O-methyltransferase inhibitor tolcapone modulates alcohol consumption and impulsive choice in alcohol use disorder. Psychopharmacology (Berl). 2020 Oct;237(10):3139-3148. doi: 10.1007/s00213-020-05599-5. Epub 2020 Jul 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Mitchell, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tolcapone in people with Alcohol Abuse and Impulsive Behavior, run by Jennifer Mitchell at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Drinks Consumed in a Laboratory Bar Session (time frame: A laboratory bar session is 1 hour long). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.