Central Sleep Apnea Comorbid With Opioid UsePhase 2NCT06521476
Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder
A Phase 2 study testing Acetazolamide in people with Central Sleep Apnea Comorbid With Opioid Use, run by Sanjay R Patel at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Central Sleep Apnea Comorbid With Opioid Use
- What is being tested?
- Acetazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea.
Who cannot join
- Sleep-related Hypoventilation.
- Other causes of Central Sleep Apnea besides Opioid Use.
- Pregnancy.
- Contraindications for Acetazolamide.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Madeline Gudobba, 412-648-9507, gudobbamk@upmc.edu
Sanjay R Patel, MD
About this study
Official title: Impact of Acetazolamide on Central Sleep Apnea Patients Receiving 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 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.
Read the detailed description
Medications used to treat opioid use disorder (MOUD) such as methadone and buprenorphine have been found to cause central sleep apnea (CSA), but the clinical ramifications are unclear. It has been hypothesized that the sleep fragmentation and intermittent hypoxemia caused by CSA from MOUD may lead to sympathetic activation, nocturnal arousal, increased anxiety, and cognitive impairment that may in turn increase drug craving and drug relapse. This mechanistic study will evaluate the potential adverse effect of CSA in patients on MOUD by evaluating the impact of acetazolamide to improve CSA and thereby lead to downstream physiologic changes in measures of sleep quality, sympathetic tone, nocturnal arousal, anxiety, cognitive functioning, and drug craving.
Eligible individuals will undergo an overnight research visit including overnight polysomnography, assessments of autonomic tone, sleep quality, nocturnal arousal, emotional distress, cognitive testing, and drug craving. Individuals with opioid-induced CSA will be randomized into a parallel-arm trial of acetazolamide vs. placebo with overnight research visit for outcome assessment at 7 days.
- Being tested
- Acetazolamide, Placebo
- Keywords
- Acetazolamide, Opioid Use Disorder, Medication for opioid use disorder (MOUD), Methadone, Buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Oral acetazolamide 250 mg daily for 7 days
PlaceboDrug
Oral placebo daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | All participants in this group will receive one acetazolamide 250 mg pill in the evening for 7 days. Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | All participants in this group will receive one matching placebo pill in the evening for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Apnea Index (CAI)
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.
Measured: 7 days
Secondary outcomes (2)
Low frequency / high-frequency ratio (LF/HF ratio)
The ratio of low frequency to high frequency spectral power from heart rate variability analysis of electrocardiogram (ECG) collected during non-rapid eye movement (NREM) sleep on overnight polysomnography
Measured: 7 days
Apnea Hypopnea Index (AHI)
The number of apneas plus hypopneas per hour of sleep on overnight polysomnography
- It can range from 0 to undefined events per hour.
- Higher values indicates severity of apneas and hypopneas.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start30 Sep 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep Apnea Comorbid With Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in 1:1 fashion to one of two parallel arms (active drug versus placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanjay R Patel
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Sanjay R Patel, University of Pittsburgh
- Investigators
- Sanjay R Patel, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521476
- Sponsor's protocol ID
- STUDY23100016
- Other IDs
- R01DA059465
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) from this clinical trial will be shared with other researchers. The IPD to be shared includes final closed dataset (after de-identification). All data will be released according to the specific timelines stated in the National Institutes of Health (NIH) Policy, ensuring no compromise to privacy, confidentiality, proprietary interests, national security, or law enforcement activities. These data will be submitted to a NIH-funded data registry for data sharing purposes.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acetazolamide on Central Sleep Apnea Patients Receiving Medication for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06521476
- Acronym / sponsor ID
- STUDY23100016
- Keywords
- Acetazolamide, Opioid Use Disorder, Medication for opioid use disorder (MOUD), Methadone, Buprenorphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sanjay R PatelUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Medications used to treat opioid use disorder (MOUD) such as methadone and buprenorphine have been found to cause central sleep apnea (CSA), but the clinical ramifications are unclear. It has been hypothesized that the sleep fragmentation and intermittent hypoxemia caused by CSA from MOUD may lead to sympathetic activation, nocturnal arousal, increased anxiety, and cognitive impairment that may in turn increase drug craving and drug relapse. This mechanistic study will evaluate the potential adverse effect of CSA in patients on MOUD by evaluating the impact of acetazolamide to improve CSA and thereby lead to downstream physiologic changes in measures of sleep quality, sympathetic tone, nocturnal arousal, anxiety, cognitive functioning, and drug craving.
Eligible individuals will undergo an overnight research visit including overnight polysomnography, assessments of autonomic tone, sleep quality, nocturnal arousal, emotional distress, cognitive testing, and drug craving. Individuals with opioid-induced CSA will be randomized into a parallel-arm trial of acetazolamide vs. placebo with overnight research visit for outcome assessment at 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in 1:1 fashion to one of two parallel arms (active drug versus placebo).
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: AcetazolamideAll participants in this group will receive one acetazolamide 250 mg pill in the evening for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboAll participants in this group will receive one matching placebo pill in the evening for 7 days. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea.
Key exclusion criteria (4 listed)
- Sleep-related Hypoventilation.
- Other causes of Central Sleep Apnea besides Opioid Use.
- Pregnancy.
- Contraindications for Acetazolamide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideOral acetazolamide 250 mg daily for 7 days | Drug | Acetazolamide |
| PlaceboOral placebo daily for 7 days | Drug | Placebo |
Primary outcome
Central Apnea Index (CAI)
Time frame: 7 days
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.
2 secondary outcomes
Low frequency / high-frequency ratio (LF/HF ratio)
Time frame: 7 days
Apnea Hypopnea Index (AHI)
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) from this clinical trial will be shared with other researchers. The IPD to be shared includes final closed dataset (after de-identification). All data will be released according to the specific timelines stated in the National Institutes of Health (NIH) Policy, ensuring no compromise to privacy, confidentiality, proprietary interests, national security, or law enforcement activities. These data will be submitted to a NIH-funded data registry for data sharing purposes.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjay R Patel, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide in people with Central Sleep Apnea Comorbid With Opioid Use, run by Sanjay R Patel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline Gudobba (412-648-9507, gudobbamk@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Apnea Index (CAI) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.