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Diuretic
Acetazolamide for Central Sleep Apnea in Opioid Users
Phase 2
Waitlist Available
Led By Sanjay R Patel, MD
Research Sponsored by Sanjay R Patel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea
Be older than 18 years old
Must not have
Sleep-related Hypoventilation
Other causes of Central Sleep Apnea besides Opioid Use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Summary
This trial aims to investigate if a medication called acetazolamide can improve central sleep apnea in patients with opioid use disorder who are being treated with methadone or buprenorphine.
Who is the study for?
This trial is for people with opioid use disorder who are being treated with methadone or buprenorphine and have developed central sleep apnea. Participants must be currently receiving medication for opioid use disorder to qualify.
What is being tested?
The study tests if acetazolamide can improve sleep apnea in patients using opioids. Half will receive acetazolamide, the other half a placebo, over 7 days. Their sleep quality and various health measures like anxiety and drug craving will be evaluated.
What are the potential side effects?
Acetazolamide may cause side effects such as tingling sensations, frequent urination, drowsiness, confusion, and changes in blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking medication for opioid addiction and have central sleep apnea.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have trouble breathing while asleep.
Select...
My central sleep apnea is not caused by opioid use.
Select...
I cannot take Acetazolamide due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Central Apnea Index (CAI)
Secondary study objectives
Apnea Hypopnea Index (AHI)
Low frequency / high-frequency ratio (LF/HF ratio)
Other study objectives
Arousal Index
Generalized Anxiety Disorder 7 (GAD-7) score
Opioid cue-induced drug craving
+4 moreSide effects data
From 2022 Phase 4 trial • 11 Patients • NCT033770499%
External Ventricular Drainage infection
9%
Hydrocephalus
9%
Pulmonary edema
9%
Cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acetazolamide Challenge
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AcetazolamideExperimental Treatment1 Intervention
All participants in this group will receive one acetazolamide 250 mg pill in the evening for 7 days.
Group II: PlaceboPlacebo Group1 Intervention
All participants in this group will receive one matching placebo pill in the evening for 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~3030
Find a Location
Who is running the clinical trial?
Sanjay R PatelLead Sponsor
1 Previous Clinical Trials
53 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,595 Previous Clinical Trials
3,328,703 Total Patients Enrolled
Sanjay R Patel, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
73 Total Patients Enrolled