Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder
Impact of Acetazolamide on Central Sleep Apnea Patients Receiving Medication for Opioid Use Disorder
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
October 16, 2025
October 1, 2025
2.3 years
July 19, 2024
October 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
7 days
Secondary Outcomes (2)
Low frequency / high-frequency ratio (LF/HF ratio)
7 days
Apnea Hypopnea Index (AHI)
7 days
Other Outcomes (7)
Overnight urinary norepinephrine levels
7 days
Pre-ejection period
7 days
Pre-sleep Arousal Scale (PSAS) score
7 days
- +4 more other outcomes
Study Arms (2)
Acetazolamide
EXPERIMENTALAll participants in this group will receive one acetazolamide 250 mg pill in the evening for 7 days.
Placebo
PLACEBO COMPARATORAll participants in this group will receive one matching placebo pill in the evening for 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea.
You may not qualify if:
- Sleep-related Hypoventilation.
- Other causes of Central Sleep Apnea besides Opioid Use.
- Pregnancy.
- Contraindications for Acetazolamide.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanjay R Patellead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay R Patel, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Placebo pill matched to look like active drug.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 19, 2024
First Posted
July 26, 2024
Study Start
September 30, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
October 16, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The IPD will become available within 1 year of analysis of primary outcome. This data will be accessible on an NIH-sponsored platform for as long as the agency maintains it.
- Access Criteria
- IPD will be available through a NIH funded registry. Access to the IPD will be governed by the policies and procedures of NIH.
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.