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Acetazolamide for Opioid-Related Sleep Apnea (MORPHO Trial)

Phase 2

Recruiting

Led By Jeremy Orr, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic opioid use (daily use for >3 months duration) with >/= 20 oral Morphine Equivalent Dose (MEqD) per day

Be older than 18 years old

Must not have

Unable or unwilling to withhold any ongoing SDB treatment (e.g. CPAP) for the duration of the study

Active cardiac disease including heart failure, chest pain, or heart rhythm problems

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Summary

This trial will examine if a drug can help chronic pain patients with breathing issues during sleep, as an alternative to a device.

Who is the study for?

This trial is for adults over 18 with chronic pain who regularly use opioids and have a sleep disorder where they stop breathing often during the night. They must not be pregnant, nursing, or planning pregnancy soon, and should not have major kidney disease, uncontrolled psychiatric disorders, recent hospitalization, heavy alcohol use, or other serious health issues.

What is being tested?

The study tests if acetazolamide can help people with opioid-related sleep breathing problems as an alternative to the usual mask treatment (CPAP). Participants will take either acetazolamide or a placebo for one week each to see which helps more.

What are the potential side effects?

Acetazolamide may cause side effects like tingling in fingers/toes, taste alterations, frequent urination, drowsiness, confusion and in rare cases severe allergic reactions especially in those allergic to sulfa drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been using opioids daily for more than 3 months at a dose of 20mg or more.

Exclusion Criteria

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

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I cannot or will not stop my sleep disorder breathing treatment during the study.

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I have heart problems like failure, chest pain, or irregular heartbeat.

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I have a condition that affects my breathing due to neurological or developmental issues.

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I am currently undergoing cancer treatment or have a limited life expectancy.

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I have been in the hospital in the last 3 months or expect to be soon.

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I do not have major sleep disorders besides sleep apnea.

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I have cirrhosis of the liver.

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I have chronic kidney disease.

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I have a lung condition that is not well-controlled asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Apnea-hypopnea index, NREM Supine

Secondary study objectives

Apnea-hypopnea index, Total

Other study objectives

10 minute psychomotor vigilance test

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Behavior

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo followed by acetazolamideExperimental Treatment2 Interventions

Subjects will start with a 1-week PLACEBO regimen Day 1-7: Placebo (matching Acetazolamide) nightly After a 2 week wash-out period, subjects will then cross-over to a 1-week ACETAZOLAMIDE regimen: Day 1-7: Acetazolamide 500 mg nightly

Group II: Acetazolamide followed by placeboExperimental Treatment2 Interventions

Subjects will start with a 1-week ACETAZOLAMIDE regimen Day 1-7: Acetazolamide 500 mg nightly After a 2 week wash-out period, subjects will then cross-over to a 1-week PLACEBO regimen: Day 1-7: Placebo (matching Acetazolamide) nightly

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetazolamide

2011

Completed Phase 4

~3030

0 / 10Eligibility criteria met