Actively Recruiting
Impact of Acetazolamide on Central Sleep Apnea Patients Receiving Medication for Opioid Use Disorder
Led by Sanjay R Patel · Updated on 2025-10-16
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sanjay R Patel
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether acetazolamide can improve central sleep apnea (CSA) caused by medications used to treat opioid use disorder (MOUD), such as methadone and buprenorphine. The study explores if improving CSA can lead to changes in physiological factors like drug craving, anxiety, and cognitive function, which may impact health outcomes in patients with opioid-induced CSA. This is a phase 2 mechanistic trial focused on understanding these effects. Participants who have central sleep apnea while on MOUD will be randomly assigned to receive either acetazolamide 250 mg or a matching placebo once daily in the evening for 7 days. After the treatment period, participants will undergo an overnight sleep study to assess breathing during sleep and sleep quality. The study compares the effects of acetazolamide versus placebo on sleep and related physiological outcomes. During the study, participants will have overnight polysomnography and assessments of autonomic tone, sleep quality, nocturnal arousal, emotional distress, cognitive function, and drug craving. The main outcome measured is the Central Apnea Index after 7 days of treatment. Additional measures include the low frequency/high frequency ratio and the Apnea Hypopnea Index. The total participation involves the initial screening and a 7-day treatment followed by outcome assessments.
CONDITIONS
Brief Title
Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea.
You will not qualify if you...
- Sleep-related Hypoventilation.
- Other causes of Central Sleep Apnea besides Opioid Use.
- Pregnancy.
- Contraindications for Acetazolamide.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants take either acetazolamide or placebo daily for 7 days to evaluate the impact on central sleep apnea and related physiological measures.
1 baseline visit and 1 follow-up visit (overnight research visits)
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
E
Elizabeth Stempkowski
J
Julia Sherman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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