AddictionPhase 4NCT02929485
Dopaminergic Modulation of Frontostriatal Function With a Dopamine Agonist and COMT Inhibitor
A Phase 4 study testing Tolcapone and Bromocriptine in people with Addiction, run by University of California, Berkeley at 2 sites in United States.
Trial summary
In this study, the investigators are looking at how people make decisions about reward-related items, both monetary and food related after taking either the dopamine agonist bromocriptine or the COMT inhibitor tolcapone, in healthy control subjects. Subjects will fill self-report questionnaires and undergo an MRI scan. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Addiction
- What is being tested?
- Tolcapone and Bromocriptine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to 31 Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 50 years.
- Subject is right-handed.
- If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device (IUD), hormonal birth control or barrier method).
- Subject is able to read and speak English.
- Subject is a high school graduate.
- Subject is able and willing to provide written and informed consent.
- Subject is able to understand and follow the instructions of the investigator, and understand all ratings scales.
- Subject is in good health.
Who cannot join
- Using cocaine, stimulants (other than THC, nicotine, \& caffeine)amphetamines, hallucinogens, "ecstasy", opiates, sedatives, pain pills, sleeping pills or other psychoactive drugs within two weeks of the start of the study OR more than 10 times in the last year.
- Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol.
- Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and physical exam performed or reviewed by the study physician.
- Subject has a history of major alcohol related complications within the proceeding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.)
- Liver function test ≥ 3 times normal upper limit.
- BAC level > 0.05% at the beginning of screening visit (within margin of error of detection).
Show all 28Show fewer
- Has a neurological dysfunction or psychiatric disorder.
- Has severe low blood pressure.
- Has uncontrolled high blood pressure.
- Regular use of any of the drugs on the tolcapone or entacapone contraindications list OR within 2 weeks of drug administration.
- Regular use of SSRIs.
- Has an allergy or intolerance to tolcapone or entacapone.
- Subject has received an investigational drug within 30 days of screening visit.
- Subject is considered unsuitable for the study in the opinion of the investigator or study physician for any other reason.
- MRI Exclusion Criteria:
- The subject has metal (metal plates, pins, wires or screws, artificial limb, joint replacement or anything that might have been inserted during an operation) in his/her body.
- Subject has a pacemaker, defibrillator, stent, or any metal implants related to heart/blood flow problems.
- Subject has worked with metals (ie. metallurgy, metal shaving, welding, soldering, etc).
- Subject has been wounded with anything metal (bullet, shrapnel or metal filling).
- Has ever gotten a piece of metal in the eye.
- Has tattoos done with ink containing metal or permanent eyeliner.
- Wears color contact lenses.
- Has a hearing problem or hearing aid, cochlear implant or past ear surgery.
- Has any irremovable dental bridges, dental plates, metal caps or any other non-removable metal in the mouth.
- The subject is claustrophobic.
- The subject is pregnant. (women only)
- Has a IUD. (women only)
- Significantly overweight.
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, 94158
About this study
In this study, the investigators are looking at how people make decisions about reward-related items, both monetary and food related after taking either the dopamine agonist bromocriptine or the COMT inhibitor tolcapone, in healthy control subjects. Subjects will fill self-report questionnaires and undergo an MRI scan.
Read the detailed description
The investigators aim to understand how the brain's dopamine system impacts monetary and food-related decision making. The investigators aim to use tolcapone and bromocriptine due to the temporary change in the levels of dopamine in the brain. The investigators also aim to determine if genetics, personality traits, or a family history of alcoholism change how these drugs affect decision making.
- Conditions
- Addiction
- Being tested
- Tolcapone, Placebo, Bromocriptine
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolcaponeDrug
Also called Tasmar
Tolcapone 200mg (single dose) administered at study visit
PlaceboDrug
Placebo (200mg) administered at study visit
BromocriptineDrug
Also called Parlodel
Drug: Bromocriptine 1.25 mg (single dose) administered at study visit
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Tolcapone | Experimental | Drug: Tolcapone 200mg (single dose) administered at study visit Receives: Drug: Tolcapone |
| Comparator: Placebo | Placebo comparator | Drug: Placebo for tolcapone administered at study visit Receives: Drug: Placebo |
| Experimental: Bromocriptine | Experimental | Drug: Bromocriptine 1.25mg (single dose) administered at study visit Receives: Drug: Bromocriptine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Effects of Placebo,Tolcapone, Bromocriptine on Reaction Time
Participants will play the Dictator Game. Behavioral responses to the game during each arm (placebo, tolcapone, and bromocriptine) will be measured by subject reaction time .
Measured: 3 weeks
Measure Effects of Placebo,Tolcapone, Bromocriptine on Accuracy
Participants will play the Dictator Game. Behavioral responses to the game during each arm (placebo, tolcapone, and bromocriptine) will be measured by subject accuracy (correct or incorrect responses).
Measured: 3 weeks
Secondary outcomes (2)
Measure Observed Changes in Resting State Neural Activity
Resting-state data will be processed off-line using neuroimaging analysis software according to standard procedures for image slice-timing correction, realignment, normalization and smoothing. Changes in regional brain activity will be measured during the placebo, tolcapone and bromocriptine conditions.
Measured: 3 weeks
Measure Observed Changes in Task Dependent Neural Activity
Task dependent fMRI data will be processed off-line using neuroimaging analysis software according to standard procedures for image slice-timing correction, realignment, normalization and smoothing. Changes in task dependent brain activity will be measured during the placebo, tolcapone and bromocriptine conditions.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJul 2013 (estimated)
- Primary completion31 Jan 2018 (estimated)
- Study completion31 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Andrew Kayser, MD,PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929485
- Sponsor's protocol ID
- 2011-11-3748
- Status last verified
- Nov 2021
- First submitted
- 28 Sep 2016
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Modulation of Frontostriatal Function With a Dopamine Agonist and COMT Inhibitor
- ClinicalTrials.gov ID
- NCT02929485
- Acronym / sponsor ID
- 2011-11-3748
- Conditions
- Addiction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Jul 2013 (estimated)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 31 Jan 2018 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators are looking at how people make decisions about reward-related items, both monetary and food related after taking either the dopamine agonist bromocriptine or the COMT inhibitor tolcapone, in healthy control subjects. Subjects will fill self-report questionnaires and undergo an MRI scan.
Detailed description
The investigators aim to understand how the brain's dopamine system impacts monetary and food-related decision making. The investigators aim to use tolcapone and bromocriptine due to the temporary change in the levels of dopamine in the brain. The investigators also aim to determine if genetics, personality traits, or a family history of alcoholism change how these drugs affect decision making.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Tolcapone | Experimental | Drug: TolcaponeDrug: Tolcapone 200mg (single dose) administered at study visit |
| Comparator: Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo for tolcapone administered at study visit |
| Experimental: Bromocriptine | Experimental | Drug: BromocriptineDrug: Bromocriptine 1.25mg (single dose) administered at study visit |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18 and 50 years.
- Subject is right-handed.
- If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device (IUD), hormonal birth control or barrier method).
- Subject is able to read and speak English.
- Subject is a high school graduate.
Key exclusion criteria (28 listed)
- Using cocaine, stimulants (other than THC, nicotine, \& caffeine)amphetamines, hallucinogens, "ecstasy", opiates, sedatives, pain pills, sleeping pills or other psychoactive drugs within two weeks of the start of the study OR more than 10 times in the last year.
- Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol.
- Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and physical exam performed or reviewed by the study physician.
- Subject has a history of major alcohol related complications within the proceeding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.)
- Liver function test ≥ 3 times normal upper limit.
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: TasmarTolcapone 200mg (single dose) administered at study visit | Drug | Experimental: Tolcapone |
| PlaceboPlacebo (200mg) administered at study visit | Drug | Comparator: Placebo |
| BromocriptineAlso: ParlodelDrug: Bromocriptine 1.25 mg (single dose) administered at study visit | Drug | Experimental: Bromocriptine |
Primary outcome
Measure Effects of Placebo,Tolcapone, Bromocriptine on Reaction Time
Time frame: 3 weeks
Participants will play the Dictator Game. Behavioral responses to the game during each arm (placebo, tolcapone, and bromocriptine) will be measured by subject reaction time .
Measure Effects of Placebo,Tolcapone, Bromocriptine on Accuracy
Time frame: 3 weeks
Participants will play the Dictator Game. Behavioral responses to the game during each arm (placebo, tolcapone, and bromocriptine) will be measured by subject accuracy (correct or incorrect responses).
2 secondary outcomes
Measure Observed Changes in Resting State Neural Activity
Time frame: 3 weeks
Measure Observed Changes in Task Dependent Neural Activity
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Andrew Kayser, MD,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 4 study testing Tolcapone and Bromocriptine in people with Addiction, run by University of California, Berkeley 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 8 inclusion and 28 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: withdrawn, as of the sponsor's last update on 16 Nov 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measure Effects of Placebo,Tolcapone, Bromocriptine on Reaction Time (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2021.