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NCT06521476 · ClinicalTrials.gov registry record · Phase 2
Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder
A Phase 2 study of Central Sleep Apnea Comorbid With Opioid Use, sponsored by Sanjay R Patel.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06521476: Recruiting Phase 2 study of Central Sleep Apnea Comorbid With Opioid Use, sponsored by Sanjay R Patel.
NCT06521476 is a Phase 2 study of Central Sleep Apnea Comorbid With Opioid Use that is actively recruiting participants, run by Sanjay R Patel. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06521476, a Phase 2 study of Central Sleep Apnea Comorbid With Opioid Use, is actively recruiting participants, sponsored by Sanjay R Patel.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with opioid use disorder treated with either methadone or buprenorphine are at risk of developing central sleep apnea (CSA) from these medications. Investigators will conduct a mechanistic trial using acetazolamide, a medicine known to improve CSA in other settings, to determine if acetazolamide can improve CSA due to medication for opioid use disorder and whether this leads to physiologic changes that might lead to reduced drug craving. Patients treated with medication for opioid use disorder and who have central sleep apnea will be randomized to treatment with acetazolamide or matching placebo for 7 days. At the end of the 7 days, they will undergo an overnight sleep study to assess the impact on breathing during sleep as well as sleep quality. In addition, measures of sympathetic tone, anxiety, arousal, cognition, and drug craving will be measured to determine if treatment of CSA with acetazolamide can produce physiologic changes that might contribute to improved health.
Primary Outcome
The number of central apneas per hour of sleep, assessed by overnight polysomnography. * It can range from 0 to undefined events per hour. * Higher values indicate more severe central sleep apnea.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acetazolamide
Study Locations (1)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09-30 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
What NCT06521476 shows while recruiting
NCT06521476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Central Sleep Apnea Comorbid With Opioid Use appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06521476 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06521476 about?
NCT06521476 is a clinical study titled "Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder". Patients with opioid use disorder treated with either methadone or buprenorphine are at risk of developing central sleep apnea (CSA) from these medications. Investigators will conduct a mechanistic trial using acetazolamide, a medicine known to improve CSA in other settings, to determine if acetazol...
What is the current status of trial NCT06521476?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-09-30. Estimated completion is 2028-02.
What conditions does trial NCT06521476 study?
This clinical trial studies the following conditions: Central Sleep Apnea Comorbid With Opioid Use.
What interventions are being tested in trial NCT06521476?
The interventions under investigation include: Placebo (DRUG), Acetazolamide (DRUG).
Who is sponsoring clinical trial NCT06521476?
This trial is sponsored by Sanjay R Patel, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06521476 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06521476's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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