Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder
NCT Number: NCT06521476
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Central Sleep Apnea Comorbid With Opioid Use
Interventions: DRUG: Acetazolamide|DRUG: Placebo
Sponsor: Sanjay R Patel
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-09
Locations: University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States

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.

Primary Outcome Measures: Central Apnea Index (CAI), 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., 7 days
Secondary Outcome Measures: Low frequency / high-frequency ratio (LF/HF ratio), 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, 7 days
Other Outcome Measures: Apnea Hypopnea Index (AHI), The number of apneas plus hypopneas per hour of sleep on overnight polysomnography, 7 days|Overnight urinary norepinephrine levels, Overnight urinary norepinephrine concentration normalized to urinary creatinine concentration, 7 days|Pre-ejection period, Pre-ejection period assessed by impedance cardiography, 7 days|Pre-sleep Arousal Scale (PSAS) score, 16-item questionnaire assessing level of nocturnal arousal, 7 days|Arousal Index, The number of cortical arousals per hour of sleep on overnight polysomnography, 7 days|PROMIS sleep disturbance score, t-score derived from 8-item PROMIS sleep disturbance questionnaire, 7 days|Generalized Anxiety Disorder 7 (GAD-7) score, 7-item questionnaire assessing anxiety symptoms, 7 days|Opioid cue-induced drug craving, The mean craving score reported after exposure to visual opioid cues relative to craving scores after viewing neutral cues, 7 days