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Anxiolytic

Buspirone for Spinal Cord Injury

Phase 2
Recruiting
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Spinal Cord Injury ≥T3
American Spinal Injury Association grade A or B or C
Must not have
Recent weight change (greater than 10 pounds)
Current use of cardioactive, antidepressant, other sedating agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days

Summary

This trial will test if Buspar can improve breathing in people with spinal cord injuries.

Who is the study for?
This trial is for adults aged 18-50 with chronic high-level spinal cord injuries (SCI) at or above T3, who are medically stable and can do arm exercises. It's not for those pregnant, on certain medications like MAO inhibitors or antidepressants, with lung diseases, bleeding disorders, uncontrolled blood pressure, heart issues, recent weight changes over 10 pounds, tobacco users or those with other major health problems.
What is being tested?
The study is testing whether Buspirone (Buspar), a medication typically used to treat anxiety disorders, can improve breathing capacity in individuals with chronic high-level SCI compared to a placebo. Participants will be randomly assigned to receive either the drug or an inactive substance.
What are the potential side effects?
Possible side effects of Buspirone may include dizziness, nausea, headache, nervousness and restlessness. Since it's being tested in people with SCI for breathing improvement rather than anxiety relief here; there might be different reactions that aren't fully known yet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My spinal cord injury is at or above the T3 level.
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My spinal injury is classified as severe to moderate.
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I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have recently lost or gained more than 10 pounds.
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I am currently taking medication for heart issues, depression, or sleep.
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I am currently taking a medication known as a monoamine oxidase inhibitor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Exercise Pulmonary Capacity
Hypercapnic Ventilatory Response
Pulmonary Function
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BuspironeActive Control1 Intervention
Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days. Other Names: Buspar
Group II: PlaceboPlacebo Group1 Intervention
Subjects take placebo pills (twice a day) for 14 Days.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
139 Previous Clinical Trials
11,058 Total Patients Enrolled

Media Library

Buspirone (Anxiolytic) Clinical Trial Eligibility Overview. Trial Name: NCT05041322 — Phase 2
Spinal Cord Injury Research Study Groups: Placebo, Buspirone
Spinal Cord Injury Clinical Trial 2023: Buspirone Highlights & Side Effects. Trial Name: NCT05041322 — Phase 2
Buspirone (Anxiolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041322 — Phase 2
~6 spots leftby Dec 2025
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