Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetazolamide, Placebo.
- Who it may be relevant to
- Registry conditions: Central Sleep Apnea Comorbid With Opioid Use. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Acetazolamide on Central Sleep Apnea Patients Receiving Medication for Opioid Use Disorder
Overview
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
- Drug Acetazolamide
Oral acetazolamide 250 mg daily for 7 days - Drug Placebo
Oral placebo daily for 7 days
Primary outcome measures
- Central Apnea Index (CAI) [Time frame: 7 days]
Secondary outcome measures (2)
- Low frequency / high-frequency ratio (LF/HF ratio) [Time frame: 7 days]
- Apnea Hypopnea Index (AHI) [Time frame: 7 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT06521476 · STUDY23100016 · R01DA059465