Modafinil for Cognition in Healthy Subjects

(COSTEP 1 Trial)

Overseen By Kaylee Enevold

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Minnesota

Must not be taking: Ketamine, MAOIs, Warfarin, others

Disqualifiers: Neurological disorder, Heart disease, Hypertension, Pregnancy, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

103 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a single dose of modafinil (a medication used to improve wakefulness) affects decision-making and brain activity in individuals without psychosis. Participants will take modafinil and engage in computer-based brain games while researchers monitor their brain activity. The research aims to enhance understanding of conditions like schizophrenia. Suitable candidates are clinically stable, fluent in English, and free from major health concerns such as heart disease or recent severe mental health issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications to join the trial?

You need to be on a stable dose of your current medications for at least 7 days before taking the study drug. If your medications have major interactions with modafinil, you may not be eligible to participate.

Is there any evidence suggesting that modafinil is likely to be safe for humans?

Research has shown that modafinil is generally well-tolerated. Studies have found that it can improve thinking skills, such as memory, without major safety concerns. For example, in individuals with bipolar disorder, modafinil was relatively safe when used with mood stabilizers. Additionally, the FDA has approved modafinil for treating sleep disorders like narcolepsy, indicating a recognized safety record.

However, some reports suggest it can cause side effects, such as jitteriness or an increased heart rate. This trial involves only a single dose, which might reduce the chance of side effects. It is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Modafinil is unique because it enhances cognitive functioning without the heavy sedation often associated with other cognitive enhancers like stimulants. Most treatments for cognitive issues work by increasing neurotransmitter levels broadly, which can lead to side effects like jitteriness or anxiety. But Modafinil stands out by specifically targeting the brain's sleep-wake cycle, promoting alertness and concentration with fewer side effects. Researchers are excited about Modafinil because it offers the potential to improve cognitive performance in healthy individuals in a way that is both effective and well-tolerated.

What evidence suggests that modafinil might be an effective treatment for decision making in psychosis spectrum disorders?

Research shows that modafinil, the treatment under study in this trial, can enhance certain mental skills, particularly during challenging tasks. Studies have found small but noticeable improvements in overall cognitive abilities compared to a placebo. Modafinil boosts non-verbal thinking and decision-making in individuals who are not fatigued. Additionally, reviews of various studies suggest that modafinil aids in planning and adapting to new situations. While these improvements are generally modest, they remain consistent across different studies. ^{1 6 7 8 9}

Who Is on the Research Team?

Caroline Demro, Ph.D.

Principal Investigator

University of Minnesota

Sophia Vinogradov, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals with an IQ of 70 or higher, who speak English, and have been clinically stable as outpatients for at least a month. They should not have had major medication changes in the last 30 days and must be on a stable dose for at least one week before receiving the study drug.

Inclusion Criteria

I am proficient in English, both in understanding and speaking.

My IQ is estimated to be 70 or above.

I have been stable and not hospitalized for the past month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

1 visit (in-person)

Intake and Clinical Appointment

Participants complete an interview, self-report questionnaires, and brain games

30 minutes to 2.5 hours

1 visit (in-person)

EEG + Medication Appointment

Participants undergo safety screening, take a single dose of modafinil, and complete brain games with EEG monitoring

4-4.5 hours

1 visit (in-person)

Follow-up

Participants are contacted via phone to monitor for any adverse effects after the study appointment

1 day

1 call (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Modafinil

Trial Overview The trial tests if a single dose of Modafinil affects decision-making skills in people without psychosis. Participants will take Modafinil once, then play computer-based brain games while their brain activity is recorded using EEG both before and after taking the drug.

How Is the Trial Designed?

Group I: COSTEP 1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31433334/

The Efficacy of Modafinil as a Cognitive Enhancer Results: The overall positive effect of modafinil over placebo across all cognitive domains was small and significant (g = 0.10; 95% confidence interval, 0.05- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0028390812003449

Effects of modafinil on non-verbal cognition, task ... The findings confirm that modafinil can enhance aspects of highly demanding cognitive performance in non-sleep deprived individuals.

3. ox.ac.uk ox.ac.uk/news/2015-08-20-review-%E2%80%98smart-drug%E2%80%99-shows-modafinil-does-enhance-cognition

Review of 'smart drug' shows modafinil does enhance ... They found 24 studies dealing with different benefits associated with taking modafinil, including planning and decision making, flexibility, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03620253

Modafinil's Effects on Cognition in Remitted MDD The aim of this study is to investigate whether modafinil can enhance cognition and have additional effects on functioning and work productivity in a sample of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3800148/

The neurobiology of modafinil as an enhancer of cognitive ... The cognitive enhancing effects of MOD and their neural correlates are being extensively investigated preclinically and in humans (Minzenberg and Carter 2008).

6. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Modafinil-Cognitive-Vitality-For-Researchers.pdf

Modafinil Evidence suggests that modafinil may improve cognition in sleep-deprived or non-sleep deprived individuals with increasing benefits as tasks become more ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03620253

Modafinil's Effects on Cognition in Remitted MDD Modafinil is a wakefulness agent with evidence that it improves some domains in cognition such as memory in those whose non-cognitive depressive symptoms have ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161813X2030036X

Memory improvement by modafinil at cost of metabolic ... Modafinil enhanced short-term memory but has no effect on long-term memory. •. Sympathetic overstimulation is implicated in influence of modafinil in rats.

9. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1246149/full

Modafinil's effects on cognition and sleep quality in ... Results suggest that modafinil is a relatively safe medication for affectively-stable BD patients when given with adjunctive mood stabilizers.