42 Participants Needed

Drug Therapy for Anxiety

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Overseen ByZeinab A Dastgheib, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two drugs, Triazolam and Buspirone, to determine their effects on brain signals related to anxiety. The researchers aim to assess whether a new, non-invasive method can measure anxiety levels by recording signals from the ear canal. Participants will receive either one of the drugs or a placebo (a harmless pill with no active ingredients) to observe changes in the signals. This trial suits individuals who have not recently undergone psychiatric treatment and do not have certain health issues, such as heart or lung disease. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could lead to new ways of understanding and measuring anxiety.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychiatric drugs, drugs that interact with the study drugs, or those with anxiety-related effects. Also, avoid antibiotics or natural health products that affect certain enzymes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both triazolam and buspirone are generally well-tolerated by patients. Triazolam often treats short-term sleep problems but can cause side effects such as daytime anxiety, memory issues, and, in rare cases, depression. These side effects typically occur with longer use, which is uncommon in short-term studies.

Buspirone is known for having fewer side effects compared to other anxiety treatments. Some individuals might experience dizziness or sleepiness, but these effects are usually mild. Recent studies have not identified any unexpected safety concerns with buspirone, and it lacks the dependence risk associated with some other anxiety medications. Overall, both medications have well-understood safety profiles, with side effects that are usually manageable.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to understand anxiety through the measurement of the hippocampal theta rhythm from the outer ear canal. Unlike traditional anxiety treatments, such as SSRIs or benzodiazepines, this approach focuses on brain wave activity, providing a new angle for diagnosing or tailoring treatments. By examining how drugs like triazolam and buspirone affect these brain rhythms, scientists hope to gain insights into their mechanisms of action and potentially improve anxiety management. This could lead to more personalized and effective therapies for those struggling with anxiety.

What evidence suggests that this trial's treatments could be effective for anxiety?

Research shows that triazolam, one of the treatments in this trial, effectively lowers anxiety. In studies, participants taking triazolam felt less anxious compared to those on a placebo and reported greater satisfaction with their treatment. Triazolam also helped with memory problems and reduced physical stress reactions. Conversely, buspirone, another treatment option in this trial, eases anxiety symptoms with fewer side effects than other treatments. It has also improved thinking skills while reducing anxiety. Both medications work differently but have proven helpful in reducing anxiety symptoms.16789

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-40 without a history of substance use disorders, neurological illnesses, major hearing loss, or severe allergies. They shouldn't be pregnant, left-handed, colorblind, have had psychological treatment or taken psychiatric drugs in the past year.

Exclusion Criteria

You have a history of drug or alcohol addiction, or someone in your family has a history of addiction.
I have heart, lung disease, or diabetes.
Major hearing loss, self-reported or as assessed by investigator via audiogram
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either triazolam, buspirone, or a placebo and undergo a series of tests and experiments

2-3 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, ensuring drug effects have worn off

1-2 hours
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal
Trial Overview The study tests if non-invasive EVestG technology can detect anxiety by measuring hippocampal theta rhythms from the ear canal. Participants will receive Buspirone or Triazolam (both known to reduce theta rhythm) versus a placebo in a double-blind setup.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: TriazolamExperimental Treatment1 Intervention
Group II: BuspironeExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Published Research Related to This Trial

In a study with 25 healthy participants, the threat of receiving shocks during navigation tasks increased anxiety levels and improved navigation performance, highlighting the hippocampus's role in both cognition and affect.
MEG analyses showed that enhanced navigation performance was linked to increased theta activity in the left posterior hippocampus, while heightened anxiety was associated with increased theta activity in the left anterior hippocampus, indicating distinct functions within the hippocampus related to spatial cognition and fear.
Distinct contributions of human hippocampal theta to spatial cognition and anxiety.Cornwell, BR., Arkin, N., Overstreet, C., et al.[2021]
The study tested the construct validity of the hippocampal theta frequency model of anxiety by using three anxiogenic drugs in rats, but found that these drugs did not increase theta frequency despite increasing anxiety behaviors.
This raises questions about the reliability of the hippocampal theta model as a true indicator of anxiety, as proven anxiolytic drugs like diazepam successfully decreased theta frequency, supporting the model's predictive validity.
FG7142, yohimbine, and βCCE produce anxiogenic-like effects in the elevated plus-maze but do not affect brainstem activated hippocampal theta.Yeung, M., Lu, L., Hughes, AM., et al.[2016]
Inhibiting the dorsal lateral septum (dLS) with the GABAA receptor agonist muscimol increased the frequency of hippocampal theta oscillations in urethane-anesthetized rats, suggesting that the dLS plays a crucial role in regulating theta activity.
Interestingly, the increase in theta frequency from dLS inhibition was accompanied by anxiolytic-like effects in anxiety models, challenging the traditional view that anxiolytic treatments slow down theta oscillations.
The lateral septum as a regulator of hippocampal theta oscillations and defensive behavior in rats.Chee, SS., Menard, JL., Dringenberg, HC.[2018]

Citations

Buspirone - StatPearls - NCBI Bookshelf - NIHBuspirone has recently come into favor, primarily due to its decreased side-effect profile compared to other anxiolytic treatments. Buspirone is primarily used ...
Effectiveness of Buspirone in Alleviating Anxiety Symptoms ...Adjunctive buspirone therapy effectively improved anxiety symptoms in depressed patients taking antidepressants, regardless of baseline symptom severity or ...
Side effects and cognitive benefits of buspironeThe results revealed a significant improvement in cognitive function among participants who received buspirone treatment, with insignificant ...
Use of Buspirone for the Treatment of AnxietyThis review evaluates the comparative effectiveness, safety and cost-effectiveness of buspirone versus BZD, SSRIs, and SNRIs. RESEARCH QUESTIONS.
Buspirone alleviates anxiety, depression, and colitisThese results suggest that buspirone can alleviate anxiety/depression and colitis through the modulation of gut microbiota composition.
Buspirone (oral route) - Side effects & dosageBuspirone may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to ...
BuSpar - accessdata.fda.govNo unexpected safety findings were associated with buspirone in these trials. There are no long-term safety or efficacy data in this population.
Material Safety Data SheetTOXICITY DATA: The following are toxicity data for the active components of this product, Buspirone ... Consult Material Safety Data Sheet for additional ...
Data sheet – Buspirone (orion) tabIn contrast to benzodiazepines, buspirone showed no signs of hypnotic-sedative, muscle relaxant, anticonvulsant, or alcohol abusive/addictive effects. In ...
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