MotivationNCT06014606
Learning and Decision-making
A study testing haloperidol 2mg and propranolol 40mg in people with Motivation, run by Maastricht University at 1 site in Netherlands.
Trial summary
A fundamental aspect of daily life decision-making involves the evaluation of costs and benefits. Neural systems underlying cost-benefit evaluation have been extensively examined, but the specific role of different neurotransmitters remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation
- What is being tested?
- haloperidol 2mg and propranolol 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2021to 16 Aug 2023
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to sign an informed consent
- Age between 18 and 35
- Body-Mass Index (BMI) between 17.5-30
- Availability for participation through the duration of the study
Who cannot join
- Diagnosis of a psychiatric or neurological disorder, including substance abuse or dependence (yes/no self-report - lifetime)
- Use of any psychopharmacological treatment 3 weeks before the test day (yes/no self-report)
- Use of any blood pressure medication (yes/no self-report - lifetime)
- Pregnancy (confirmed via urine pregnancy test) or nursing (yes/no self-report) or have plans to get pregnant in the near future (yes/no self-report) (females only)
- Diagnosis of a cardiac disease (medical questionnaire), obstructive respiratory disease (medical questionnaire), abnormal blood pressure (diastolic< 60mmHg; systolic< 90mmHg) (medical screening)
- Chronic renal failure (medical questionnaire)
Show all 12Show fewer
- Hypothyroidism (medical questionnaire)
- Diabetes (medical questionnaire)
- Hypersensitivity to phenothiazines (medical questionnaire)
- Diagnosis of a cardiac disease (medical questionnaire)
- Alcohol consumption in the 24 hours before the test session starts (yes/no self-report)
- Food intake less than 3 hours before the test day (yes/no self-report)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Does the Brain Learn About Positive and Negative Things?
A fundamental aspect of daily life decision-making involves the evaluation of costs and benefits. Neural systems underlying cost-benefit evaluation have been extensively examined, but the specific role of different neurotransmitters remains unclear. Numerous studies suggest that both dopamine (DA) and norepinephrine (NE) are closely related to reinforcement learning, guided exploration/exploitation, and behavioural energisation, although no studies to date have investigated the distinct role of DA and NE on cost-benefit decision-making and learning in human subjects.
- Conditions
- Motivation
- Being tested
- placebo, haloperidol 2mg, propranolol 40mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
oral formulation
haloperidol 2mgDrug
oral formulation
propranolol 40mgDrug
oral formulation
| Study group | Role | What they receive |
|---|---|---|
| HV/Placebo | Placebo comparator | Oral placebo (tablet) Receives: Drug: placebo |
| HV/Haloperidol | Active comparator | 2mg (oral) Receives: Drug: haloperidol 2mg |
| HV/Propranolol | Active comparator | 40mg (oral) Receives: Drug: propranolol 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-benefit reinforcement learning performance
2-choice reinforcement learning task (based on Voulgaropoulou et al., 2021 PNEC)
Measured: ~ 2.5 hours post-drug administration
Secondary outcomes (1)
Effort-based decision-making
motivation to acquire rewards (e.g., Reddy et al. 2015)
Measured: ~ 2 hours post-drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Mar 2021
- Primary completion30 Apr 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MotivationStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014606
- Sponsor's protocol ID
- DANE1
- Status last verified
- Aug 2023
- First submitted
- 5 Sep 2022
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Voulgaropoulou SD, Fauzani F, Pfirrmann J, Vingerhoets C, van Amelsvoort T, Hernaus D. Asymmetric effects of acute stress on cost and benefit learning. Psychoneuroendocrinology. 2022 Apr;138:105646. doi: 10.1016/j.psyneuen.2021.105646. Epub 2021 Dec 24.
PubMed 35065334
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does the Brain Learn About Positive and Negative Things?
- ClinicalTrials.gov ID
- NCT06014606
- Acronym / sponsor ID
- DANE1
- Conditions
- Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 28 Aug 2023 (actual)
- 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.
A fundamental aspect of daily life decision-making involves the evaluation of costs and benefits. Neural systems underlying cost-benefit evaluation have been extensively examined, but the specific role of different neurotransmitters remains unclear. Numerous studies suggest that both dopamine (DA) and norepinephrine (NE) are closely related to reinforcement learning, guided exploration/exploitation, and behavioural energisation, although no studies to date have investigated the distinct role of DA and NE on cost-benefit decision-making and learning in human subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HV/Placebo | Placebo comparator | Drug: placeboOral placebo (tablet) |
| HV/Haloperidol | Active comparator | Drug: haloperidol 2mg2mg (oral) |
| HV/Propranolol | Active comparator | Drug: propranolol 40mg40mg (oral) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willingness to sign an informed consent
- Age between 18 and 35
- Body-Mass Index (BMI) between 17.5-30
- Availability for participation through the duration of the study
Key exclusion criteria (12 listed)
- Diagnosis of a psychiatric or neurological disorder, including substance abuse or dependence (yes/no self-report - lifetime)
- Use of any psychopharmacological treatment 3 weeks before the test day (yes/no self-report)
- Use of any blood pressure medication (yes/no self-report - lifetime)
- Pregnancy (confirmed via urine pregnancy test) or nursing (yes/no self-report) or have plans to get pregnant in the near future (yes/no self-report) (females only)
- Diagnosis of a cardiac disease (medical questionnaire), obstructive respiratory disease (medical questionnaire), abnormal blood pressure (diastolic< 60mmHg; systolic< 90mmHg) (medical screening)
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 |
|---|---|---|
| placebooral formulation | Drug | HV/Placebo |
| haloperidol 2mgoral formulation | Drug | HV/Haloperidol |
| propranolol 40mgoral formulation | Drug | HV/Propranolol |
Primary outcome
Cost-benefit reinforcement learning performance
Time frame: ~ 2.5 hours post-drug administration
2-choice reinforcement learning task (based on Voulgaropoulou et al., 2021 PNEC)
1 secondary outcome
Effort-based decision-making
Time frame: ~ 2 hours post-drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Results publication: PubMed 35065334Voulgaropoulou SD, Fauzani F, Pfirrmann J, Vingerhoets C, van Amelsvoort T, Hernaus D. Asymmetric effects of acute stress on cost and benefit learning. Psychoneuroendocrinology. 2022 Apr;138:105646. doi: 10.1016/j.psyneuen.2021.105646. Epub 2021 Dec 24.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing haloperidol 2mg and propranolol 40mg in people with Motivation, run by Maastricht University at 1 site in Netherlands.
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 4 inclusion and 12 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cost-benefit reinforcement learning performance (time frame: ~ 2.5 hours post-drug administration). 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 NCT06014606, 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 28 Aug 2023.