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NCT Number: NCT06521476

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 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.

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Key information

Conditions

Central Sleep Apnea Comorbid With Opioid Use Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Kristine Wilckens, PhD

SUB_INVESTIGATOR

Madeline Gudobba

CONTACT

[email protected]

412-648-9507

Sanjay R Patel, MD

PRINCIPAL_INVESTIGATOR

Tae Woo Park, MD

SUB_INVESTIGATOR

Venkatesh Krishnamurthy, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetazolamide

Drug

Oral acetazolamide 250 mg daily for 7 days

Placebo

Drug

Oral placebo daily for 7 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. Low frequency / high-frequency ratio (LF/HF ratio)

    Time frame: 7 days

    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

  2. Apnea Hypopnea Index (AHI)

    Time frame: 7 days

    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.

Other outcomes

  1. Overnight urinary norepinephrine levels

    Time frame: 7 days

    Overnight urinary norepinephrine concentration normalized to urinary creatinine concentration

  2. Pre-ejection period

    Time frame: 7 days

    Pre-ejection period assessed by impedance cardiography

  3. Pre-sleep Arousal Scale (PSAS) score

    Time frame: 7 days

    16-item questionnaire assessing level of nocturnal arousal

    • It can range from 16 to 80.
    • Higher scores indicate higher levels of nocturnal arousal.

  4. Arousal Index

    Time frame: 7 days

    The number of cortical arousals per hour of sleep on overnight polysomnography.

    • It can range from 0 to undefined events per hour.
    • Higher values indicate more severe sleep disturbance.

  5. Generalized Anxiety Disorder 7 (GAD-7) score

    Time frame: 7 days

    7-item questionnaire assessing anxiety symptoms

    • It can range from 0 to 21.
    • Higher scores indicate more severe anxiety.

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance score

    Time frame: 7 days

    t-score derived from 8-item PROMIS sleep disturbance questionnaire

    • Population mean is 50 and standard deviation is 10.
    • Higher values indicate greater levels of sleep disturbance.

  7. Opioid cue-induced drug craving

    Time frame: 7 days

    The mean craving score reported after exposure to visual opioid cues relative to craving scores after viewing neutral cues.

    • Mean craving score ranges from 0 to 10.
    • Higher scores indicate higher level of drug craving.

Study contacts

Contact information is provided by the study sponsor or research team.

Madeline Gudobba

CONTACT

[email protected]

412-648-9507

Stormy Green

CONTACT

[email protected]

412-383-9469

Sponsors and collaborators

Lead sponsor

Sanjay R Patel

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Impact of Acetazolamide on Central Sleep Apnea Patients Receiving Medication for Opioid Use Disorder

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 26, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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