Home/Get Matched/NCT03954483
NARECRUITING
View on ClinicalTrials.gov

Testing Buspirone against a placebo for anxiety

Official title: Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal

Condition: AnxietySponsor: University of ManitobaTarget enrollment: 42

Interventions

DRUG

Buspirone 10 Mg Oral Tablet

Orally administered prior to experiments.

DRUG

Triazolam 0.25 MG Oral Tablet

Orally administered prior to experiments.

DRUG

Placebo oral tablet

Orally administered prior to experiments.

Canadian Sites (1)

Riverview Health Centre

Winnipeg, Manitoba, Canada

RECRUITING

Eligibility Criteria

See who this study is looking for17 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Males and females who are between 18 and 40 years of age.

Exclusion

  • Allergic skin reactions to chemical agents including detergents.
  • Psychological treatment in the past year or taking any psychiatric drug.
  • Drugs that interact with the study drugs or that have anxiolytic/anxiogenic properties.
  • Antibiotics or natural health products that inhibit/induce CYP3A4 or CYP2D6.
  • History of substance use disorder or family history of substance use disorder.
  • Individuals who have a current diagnosis, or history of, a neurological illness.
  • A history of stroke, head injury, loss of consciousness, epilepsy.
  • Kidney or liver disease/impairment.
  • COPD or sleep apnea.
  • Skin lesions involving the ear canal, self-reported or as assessed in examination at the lab.
  • Any unknown balance disorders, as assessed by investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → via balance test.
  • Major hearing loss, self-reported or as assessed by investigator via audiogram.
  • Heart disease, lung disease or diabetes.
  • Influenza, Covid-19, or flu-like symptoms.
  • Recovering from an accident, injury, or operation.
  • Pregnancy (or breastfeeding), left handedness, or colour blindness.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to identify or measure a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

What is being given or done in this study: Buspirone 10 Mg Oral Tablet, Triazolam 0.25 MG Oral Tablet, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → oral tablet.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
  • armsInterventionsModule.interventions[].name
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

Neither you nor the study team would know which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.

There are 3 groups in this study.

From the trial registry

Built from this field:

  • armsInterventionsModule.armGroups[].type
Who the study is looking for

The study lists an age range of 18 years to 40 years.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 42 people.

The study is currently expected to finish around October 2027.

The main measurement is taken over: Derived from EEGs recorded for 30-45 mins.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

EEG power spectrum — measured over Derived from EEGs recorded for 30-45 mins.

4-12 Hz modulation — measured over Derived from EEGs recorded for 30-45 mins.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT03954483 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Buspirone 10 Mg Oral TabletDrug

Orally administered prior to experiments.

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Triazolam 0.25 MG Oral TabletDrug

Orally administered prior to experiments.

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Placebo oral tabletDrug

Orally administered prior to experiments.

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 18 years to 40 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

Neither you nor the study team would know which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 18 years to 40 years.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Derived from EEGs recorded for 30-45 mins.

The study as a whole is currently expected to finish around 2027-10-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 42 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Winnipeg, Manitoba, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

New technologies are needed to help diagnose anxiety disorders. EVestG has facilitated the identification of numerous possible biomarkers of several psychiatric disorders. Some EVestG features seem to be caused by differences in low-frequency modulation that is consistent (both in frequency and behaviour) with the hippocampal rhythm (theta), which is known to play a role in anxiety. Critically, there is ample support in the literature for an anatomical and functional basis for the modulation of vestibular signals via theta. If anxiety could be measured continuously, perhaps throughout a patient's day, or throughout a task, it might be able to confirm an anxiety disorder. However, current techniques for measuring theta are highly invasive, performed rarely, and only in epilepsy patients. EVestG technology, however, is non-invasive, and could potentially record anxiety levels in any subject for extended periods of time. The proposed study will attempt to identify hippocampal theta in vestibular signals in healthy participants through a double-blind administration of two different drugs that are dissimilar both pharmacologically and in acute clinical effects but which are known to reduce the theta rhythm.

Think this trial might be right for you?

Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.

See if this trial could fit you

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.