Blood Pressure Medication for Chronic Pain

(PASSION Trial)

Overseen By Seth W Holwerda, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Kansas Medical Center

Must not be taking: Antihypertensives, Insulin, NSAIDs

Disqualifiers: Renal failure, Neurological disease, Cancer, others

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effects of a common blood pressure medication, Hydrochlorothiazide, on chronic pain levels. Participants will take the medication for two weeks and a placebo (a pill with no active ingredients) for another two weeks. The trial targets individuals with chronic low back pain and a spinal cord stimulator implant, who also have high blood pressure. Participants must be willing to visit a research lab and undergo a blood draw. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

If you are currently taking any blood pressure medication, you cannot participate in this trial. If you are taking NSAIDs (non-steroidal anti-inflammatory drugs), you must stop them for at least 3 days before and during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hydrochlorothiazide, a common medication for high blood pressure, is usually well-tolerated when taken as directed. It has been used for a long time and is often prescribed to manage high blood pressure. However, like any medication, it can cause side effects. Some people might feel dizzy, especially when they first start taking it. Serious side effects are rare but can include skin reactions or joint pain.

In this trial, participants take a 12.5 mg dose of hydrochlorothiazide twice a day. This lower dose may help reduce the chances of side effects. Since this is an early-phase study, the main goal is to monitor any side effects and assess how the treatment affects chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hydrochlorothiazide, a blood pressure medication, for chronic pain because it offers a fresh approach by potentially addressing pain through blood pressure regulation. Unlike traditional pain relievers like opioids, which can have addictive properties, hydrochlorothiazide is a diuretic that reduces fluid retention and lowers blood pressure, which might indirectly alleviate pain. This repurposing of a common hypertension drug could lead to fewer side effects and offer a safer alternative for managing chronic pain.

What evidence suggests that this treatment might be an effective treatment for chronic pain?

Research has shown that hydrochlorothiazide, a common medication for high blood pressure, might also aid in pain relief. One study examined its ability to ease ongoing stomach pain, suggesting it could help with pain beyond just lowering blood pressure. In this trial, some participants will receive hydrochlorothiazide to explore its potential for pain reduction. Hydrochlorothiazide helps the body remove extra water, which lowers blood pressure. While primarily used for high blood pressure, its potential to reduce pain remains under investigation. There is no clear consensus yet on using hydrochlorothiazide specifically for long-term pain, but its effects on pain continue to be researched. ^{2 6 7 8 9}

Who Is on the Research Team?

Seth W Holwerda, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 40 and 79 years old.

My blood pressure is 140/90 mmHg or higher.

I have long-term lower back pain.

Exclusion Criteria

I am currently on medication for high blood pressure.

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

I am pregnant or planning to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 weeks of a diuretic and 2 weeks of placebo in a crossover design to assess the impact on pain management and blood pressure

4 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain and blood pressure

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hydrochlorothiazide 12.5mg
• Placebo
• Spinal Cord Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Hydrochlorothiazide Pill (12.5 mg twice a day) Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Has no active ingredients but is made to look like the study drug. 2 pills/day for 14 days.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3252778/

Effect of hydrochlorothiazide on reducing recurrent abdominal ... This study assessed the possible effect of hydrochlorothiazide (HCT) on soothing recurrent abdominal pain (RAP).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9509303/

The Effects of Pain and Analgesic Medications on Blood ... Pain and analgesics may induce a clinically significant BP destabilization. The implications on hypertension incidence and BP control remain unclear.

3. mayoclinic.org mayoclinic.org/drugs-supplements/hydrochlorothiazide-oral-route/description/drg-20071841

Hydrochlorothiazide (oral route) - Side effects & dosage Hydrochlorothiazide is a thiazide diuretic (water pill). It is used to help reduce the amount of water in the body by increasing the flow of urine.

4. jacc.org jacc.org/doi/10.1016/j.jacc.2015.10.083

Efficacy of Low-Dose Chlorthalidone and ... This study compared chlorthalidone, 6.25 mg daily, with HCTZ, 12.5 mg daily, by 24-h ambulatory blood pressure (ABP) monitoring and evaluated efficacy.

5. ohdsi.org ohdsi.org/ohdsi-news-updates/chlorthalidone-side-effects-study/

Recommended Diuretic Causes More Side Effects than ... In the current paper, the researchers found that chlorthalidone and hydrochlorothiazide were similarly effective in preventing heart attack, hospitalization for ...

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9ACCRD_HYDROCHLORIAZIDE_TAB_12_5MG_1000_BT.pdf

Hydrochlorothiazide Tablets USP 12.5 mg, 25 mg and 50 mg Safety Data Sheet. According To Federal Register / Vol. 77, No. 58 / Monday ... Chronic Symptoms: None expected under normal conditions of use. 4.3 ...

7. medline.com medline.com/media/catalog/Docs/MSDS/MSD_SDSD12910.pdf

Material Safety Data Sheet Adverse Effects: Adverse effects of thiazide diueretics are usually dose-related and may include increased urination, confusion, convulsions ...

8. drugs.com drugs.com/sfx/hydrochlorothiazide-side-effects.html

Hydrochlorothiazide Side Effects: Common, Severe, Long ... This medicine may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy or ...

9. webmd.com webmd.com/drugs/2/drug-5310/hydrochlorothiazide-oral/details

Hydrochlorothiazide - Uses, Side Effects, and More Joint pain. Severe Skin Reactions. Hydrochlorothiazide can cause severe skin reactions called Stevens-Johnson Syndrome (SJS) and Toxic ...