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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06521476
Enrollment
40
Registered
2024-07-26
Start date
2025-09-30
Completion date
2028-02-01
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sleep Apnea Comorbid With Opioid Use

Keywords

Acetazolamide, Opioid Use Disorder, Medication for opioid use disorder (MOUD), Methadone, Buprenorphine

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.

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.

Interventions

DRUGAcetazolamide

Oral acetazolamide 250 mg daily for 7 days

DRUGPlacebo

Oral placebo daily for 7 days

Sponsors

Sanjay R Patel
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Placebo pill matched to look like active drug.

Intervention model description

Participants will be randomized in 1:1 fashion to one of two parallel arms (active drug versus placebo).

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea.

Exclusion criteria

* Sleep-related Hypoventilation. * Other causes of Central Sleep Apnea besides Opioid Use. * Pregnancy. * Contraindications for Acetazolamide.

Design outcomes

Primary

MeasureTime frameDescription
Central Apnea Index (CAI)7 daysThe 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.

Secondary

MeasureTime frameDescription
Low frequency / high-frequency ratio (LF/HF ratio)7 daysThe 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
Apnea Hypopnea Index (AHI)7 daysThe 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.

Countries

United States

Contacts

CONTACTMadeline Gudobba
gudobbamk@upmc.edu412-648-9507
CONTACTStormy Green
greens27@upmc.edu412-383-9469
PRINCIPAL_INVESTIGATORSanjay R Patel, MD

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026