Recruiting
Phase 2

Epidiolex

Sponsor:

University of Wisconsin, Madison

Code:

NCT06840899

Conditions

Supra-sacral Spinal Cord Injury

Spinal Cord Injury

Urinary Incontinence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBD

Study Details

Brief summary:

The goal of this feasibility study is to learn whether Cannabidiol (CBD) can improve urinary incontinence and other symptoms in people with recent spinal cord injury (SCI).

Participants will take Epidiolex (purified CBD) for 90 days

Conditions

Supra-sacral Spinal Cord Injury

Spinal Cord Injury

Urinary Incontinence

Study ID

NCT06840899

Start date

Feb 13, 2026

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • >18 years of age
  • History of supra-sacral spinal cord injury of any mechanism
  • Urinary incontinence with ≥2 episodes of urinary incontinence per day (outside of spinal shock)
  • Willingness to participate in drug intervention trial
  • English-speaking (able to provide consent and complete questionnaires)

Exclusion Criteria:

  • History of intravesical Botox
  • Actively taking >15 mg of Oxybutynin single dose or equivalent dose of alternative anticholinergic medication for bladder symptoms
  • Use of Cannabis (any form) outside of study as determined by urine drug screen after washout period of 1 month if prior Cannabis use reported
  • Thought or mood disorder aside from depression

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBD for urinary incontinence

Participants will take CBD for 90 days

Interventions

CBD

Twice daily 100mg cannabidiol (CBD)

Primary outcome measure

  • Adherence to CBD (Epidiolex) regimen [ Time Frame: 90 days ]
  • Completion of 72-hour voiding diary [ Time Frame: 90 days ]
  • Number of adverse events [ Time Frame: 120 days ]

Central Contacts and Locations

Central contacts

Maria Flory

608-262-8652flory@ortho.wisc.edu

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Maria Flory

608-262-8652flory@ortho.wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-03-04.