Healthy AdultsPhase 4NCT03616717
Modafinil Effects on EEG Biomarkers of Reward and Motivation
A Phase 4 study testing Modafinil in people with Healthy Adults, run by University of California, San Diego at 1 site in United States.
Trial summary
The effects of modafinil on measures of brain electrical activity will be tested. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 30 Sep 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- history of substance abuse
- mental illness in a first degree relative
- significant medical illness (e.g. cancer, diabetes, heart disease, HIV)
- history of seizure
- open head injury or closed head injury with loss of consciousness > 1 min
- pregnancy
Show all 10Show fewer
- current psychotropic drug use
- R-hand injury
- hearing or visual impairment
- urine toxicology positive for recreational drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego; Clinical Teaching Facilities, Hillcrest
San Diego, California, 92103
About this study
Official title: Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms
The effects of modafinil on measures of brain electrical activity will be tested.
- Conditions
- Healthy Adults
- Being tested
- Modafinil, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Drug: modafinil Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.
Other Names:
Provigil Alertec Modavigil
placeboDrug
Drug: Placebo Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.
| Study group | Role | What they receive |
|---|---|---|
| modafinil 100 mg | Active comparator | Drug: modafinil, Provigil, Alertec, Modavigil
Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. Receives: Drug: Modafinil |
| modafinil 200 mg | Active comparator | Drug: modafinil, Provigil, Alertec, Modavigil
Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. Receives: Drug: Modafinil |
| placebo | Placebo comparator | Drug: modafinil, Provigil, Alertec, Modavigil
Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reward Positivity
Frontal alpha power by block in the probabilistic learning task
Measured: 1 year
Motivation Signal
Parietal EEG alpha power peak in first - final step toward breakpoint
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start16 Oct 2018
- Primary completion31 May 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Experimental medicine model; not an intervention. Within-subject double-blind placebo-controlled dose-response study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jared W. Young, University of California, San Diego
- Investigators
- Jared W Young, Ph.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616717
- Sponsor's protocol ID
- 4UH3MH109168-03
- Status last verified
- Apr 2022
- First submitted
- 18 Jul 2018
- Last updated
- 6 Apr 2022
- Results posted
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms
- ClinicalTrials.gov ID
- NCT03616717
- Acronym / sponsor ID
- 4UH3MH109168-03
- Conditions
- Healthy Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Aug 2018 (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.
The effects of modafinil on measures of brain electrical activity will be tested.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Experimental medicine model; not an intervention. Within-subject double-blind placebo-controlled dose-response study.
| Arm | Type | Receives |
|---|---|---|
| modafinil 100 mg | Active comparator | Drug: ModafinilDrug: modafinil, Provigil, Alertec, Modavigil Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. |
| modafinil 200 mg | Active comparator | Drug: ModafinilDrug: modafinil, Provigil, Alertec, Modavigil Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. |
| placebo | Placebo comparator | Drug: placeboDrug: modafinil, Provigil, Alertec, Modavigil Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- history of substance abuse
- mental illness in a first degree relative
- significant medical illness (e.g. cancer, diabetes, heart disease, HIV)
- history of seizure
- open head injury or closed head injury with loss of consciousness > 1 min
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 |
|---|---|---|
| ModafinilDrug: modafinil Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. Other Names: Provigil Alertec Modavigil | Drug | modafinil 100 mg, modafinil 200 mg |
| placeboDrug: Placebo Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. | Drug | placebo |
Primary outcome
Reward Positivity
Time frame: 1 year
Frontal alpha power by block in the probabilistic learning task
Motivation Signal
Time frame: 1 year
Parietal EEG alpha power peak in first - final step toward breakpoint
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 6 Apr 2022.
- 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.
Jared W Young, Ph.D. principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Modafinil in people with Healthy Adults, run by University of California, San Diego at 1 site 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 0 inclusion and 10 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 6 Apr 2022. 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 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 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?
Reward Positivity (time frame: 1 year). 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 6 Apr 2022.