Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Acetazolamide
  Oral acetazolamide 250 mg daily for 7 days
• Препарат Placebo
  Oral placebo daily for 7 days

Первичные конечные точки

• Central Apnea Index (CAI) [Срок оценки: 7 days]

Вторичные конечные точки (2)

• Low frequency / high-frequency ratio (LF/HF ratio) [Срок оценки: 7 days]
• Apnea Hypopnea Index (AHI) [Срок оценки: 7 days]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06521476 · STUDY23100016 · R01DA059465

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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