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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

MORPHO Trial 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.Check my eligibility

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.See study design

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.

MORPHO Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

MORPHO Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apnea-hypopnea index, NREM Supine

Secondary outcome measures

Apnea-hypopnea index, Total

Other outcome measures

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

MORPHO 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

~2910

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,521,010 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,090 Total Patients Enrolled

Jeremy Orr, MDPrincipal InvestigatorUC San Diego

1 Previous Clinical Trials

62 Total Patients Enrolled

Frequently Asked Questions

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

Has Acetazolamide earned a go-ahead from the Food and Drug Administration?

"Acetazolamide's safety is rated at a 2 due to the lack of evidence supporting its efficacy. Nevertheless, there have been numerous trials that support its relative harmlessness."

Answered by AI

Is this research endeavor currently enrolling participants?

"It appears that this clinical trial is not currently enrolling. The protocol was initialised on September 29th 2023 and last amended 19 days later, however 815 other trials are still actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Managing Opioid Related Sleep Apnea With Acetazolamide

Jeremy Orr, M.D. 2023. "Managing Opioid Related Sleep Apnea With Acetazolamide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043830.

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