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Blood Pressure Medication for Chronic Pain (PASSION Trial)

Phase < 1

Waitlist Available

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)

Must not have

Currently taking any antihypertensive medication

Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk <10%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 5 (day 35)

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for high blood pressure.

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My blood pressure is slightly high, but my risk for heart disease is low.

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I am pregnant or planning to become pregnant.

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I have had a stroke in the past.

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I feel weak or faint when I stand up.

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I have kidney failure.

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I am currently diagnosed with cancer.

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I have high blood pressure due to a specific condition.

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I take insulin or medication to lower my blood sugar.

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I do not have any active infections.

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My blood pressure is 160/100 or higher and I am on two medications for it.

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I have a history of a neurological condition like dementia or Parkinson's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 5 (day 35)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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 1. Condition/disease indication(s): Hypertension 2. Subject population: Chronic pain 3. Dose(s): 12.5 mg twice per day for 14 days. 4. Administration: Oral 5. 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

0 / 17Eligibility criteria met