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Blood Pressure Medication for Chronic Pain (PASSION Trial)

Phase < 1
Recruiting
Led By Seth W Holwerda, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or Female, age 40-79
Stage 2 hypertension (BP ≥ 140/90 mmHg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 5 (day 35)
Awards & highlights

PASSION Trial Summary

This trial is testing whether a commonly used blood pressure medication can help relieve symptoms of chronic pain.

Who is the study for?
This trial is for adults aged 40-79 with chronic low back pain and high blood pressure (BP 130-139/80-89 mmHg or higher), who have a spinal cord stimulator implant. Participants should not be on blood pressure medication, pregnant, or have conditions like diabetes requiring insulin, active infections, renal failure, history of stroke or certain neurological diseases.Check my eligibility
What is being tested?
The PASSION study is testing the effects of Hydrochlorothiazide (a common diuretic for high blood pressure) versus a placebo on managing chronic pain in participants with spinal cord stimulators. It's a crossover design where patients will switch between the drug and placebo after two weeks.See study design
What are the potential side effects?
Possible side effects include reactions to the diuretic such as weakness upon standing (symptomatic hypotension), allergic responses to thiazide-type drugs, and potentially having to stop NSAIDs during the trial.

PASSION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 79 years old.
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My blood pressure is 140/90 mmHg or higher.
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I have long-term lower back pain.
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I have a spinal cord stimulator implant for chronic pain.
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My blood pressure is between 130-139/80-89 mmHg and I have a high risk of heart disease.

PASSION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 5 (day 35)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 5 (day 35) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Visit 1 PainDETECT Questionnaire to Visit 2
Change from Visit 2 PainDETECT Questionnaire to Visit 3
Change from Visit 3 PainDETECT Questionnaire to Visit 4
+16 more

PASSION Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hydrochlorothiazide Pill (12.5 mg twice a day)Experimental Treatment1 Intervention
Planned use in this study Condition/disease indication(s): Hypertension Subject population: Chronic pain Dose(s): 12.5 mg twice per day for 14 days. Administration: Oral Dosing regimen: 12.5 mg twice per day
Group II: PlaceboPlacebo Group1 Intervention
Has no active ingredients but is made to look like the study drug. 2 pills/day for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrochlorothiazide 12.5mg
2010
N/A
~1460

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
462 Previous Clinical Trials
169,171 Total Patients Enrolled
4 Trials studying Chronic Pain
310 Patients Enrolled for Chronic Pain
Seth W Holwerda, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
2 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Chronic Pain
72 Patients Enrolled for Chronic Pain

Media Library

Hydrochlorothiazide 12.5mg (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04676399 — Phase < 1
Chronic Pain Research Study Groups: Hydrochlorothiazide Pill (12.5 mg twice a day), Placebo
Chronic Pain Clinical Trial 2023: Hydrochlorothiazide 12.5mg Highlights & Side Effects. Trial Name: NCT04676399 — Phase < 1
Hydrochlorothiazide 12.5mg (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04676399 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of this experiment limited to those aged 85 or younger?

"This clinical trial is aiming to enroll patients who are between 40 and 79 years of age."

Answered by AI

What maladies is Hydrochlorothiazide 12.5mg typically prescribed to address?

"To address sodium retention, Hydrochlorothiazide 12.5mg is commonly prescribed. Additionally, this drug can be useful in treating edema, inadequate response to other treatments, and hypertension not adequately managed with single-agent therapy."

Answered by AI

To whom is enrollment in this clinical trial available?

"This trial is seeking out 36 individuals between the age of 40 to 79 who have been diagnosed with hypertension. The main criteria for applicants are having chronic low back pain, regardless of gender."

Answered by AI

What is the total number of participants in this trial?

"Indeed, the clinicaltrials.gov database confirms that this trial is presently searching for participants to enroll. Originally posted on February 8th 2022 and recently edited today, the research aims to recruit 36 people from a single medical centre."

Answered by AI

Could you provide a synopsis of prior investigations that have utilized Hydrochlorothiazide 12.5mg?

"Presently, there are 12 active trials for Hydrochlorothiazide 12.5mg with 5 in Phase 3 of the study process. The majority are based in Kansas City, yet 80 different research sites offer clinical studies on this medication across multiple states."

Answered by AI

Are there any available openings to join this investigation?

"Clinicaltrials.gov confirms that this medical trial, first posted on February 8th 2022, is actively seeking patients as of the date of its most recent update."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
The Marc A. Asher Comprehensive Spine Center at the Kansas University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I hope the study can address these conditions so that I can cut back on all the medications I take for all of these conditions.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
2022. "Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04676399.
All > Blood Pressure > Hypertension
~8 spots leftby Dec 2024
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