NCT05041322

Brief Summary

The purpose of this study is to find out if taking the drug Buspar will increase breathing capacity in individuals with spinal cord injuries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 18, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

3.9 years

First QC Date

August 6, 2021

Results QC Date

May 22, 2025

Last Update Submit

September 16, 2025

Conditions

Spinal Cord Injuries

Keywords

Pulmonary Function TestBuspirone HydrochlorideOxygen Consumption

Outcome Measures

Primary Outcomes (4)

  • Pulmonary Function

    Forced expiratory volume over 1 second (FEV1).

    14 Days

  • Hypercapnic Ventilatory Response

    A change in the drive to breathe with a change in carbon dioxide

    14 Days

  • Sleep Quality

    Sleep apneas and hypopneas per hour.

    14 Days

  • Exercise Pulmonary Capacity

    Change in peak oxygen consumption during exercise

    14 Days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects take placebo pills (twice a day) for 14 Days.

Drug: Placebo

Buspirone

ACTIVE COMPARATOR

Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days. Other Names: Buspar

Drug: Buspirone

Interventions

BuspironeDRUG

Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days.

Also known as: BuSpar, Buspirone Hydrochloride
Buspirone
PlaceboDRUG

Subjects take placebo pills (twice a day) for 14 Days.

Also known as: Control
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic high-level SCI (at least 24-months post injury)
  • Age 18 to 50 years.
  • Medically stable
  • Spinal Cord Injury ≥T3
  • American Spinal Injury Association grade A or B or C.
  • Able to perform arm crank exercise.

You may not qualify if:

  • Cardiomyopathy
  • High blood pressure( \>140/90 mmHg or you are taking high blood pressure medication)
  • Significant irregular heartbeat
  • Heart disease
  • Chronic lung disease (COPD, bronchitis)
  • Current use of cardioactive or antidepressant drugs
  • Family history of significant irregular heart beat or sudden cardiac death
  • Orthostatic hypotension (symptomatic fall in blood pressure \>30 mmHg when upright)
  • Current grade 2 or greater pressure ulcers at relevant contact site
  • Neurological disease (stroke, peripheral neuropathy, myopathy)
  • Arm or shoulder conditions that limit ability to perform arm crank exercise
  • History of bleeding disorder, diabetes, kidney disease, cancer, other neurological disease
  • Recent weigh change (greater than 10 pounds)
  • Regular use of tobacco
  • Intrathecal baclofen pump,
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic Compounds

Limitations and Caveats

Insufficient sample size to make any determination of efficacy.

Results Point of Contact

Title
Jason Hamner
Organization
Spaulding Hospital Cambridge
jhamner@mgb.org
6177585501

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., Director, Cardiovascular Research Laboratory

Study Record Dates

First Submitted

August 6, 2021

First Posted

September 13, 2021

Study Start

November 29, 2020

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

September 18, 2025

Results First Posted

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)