Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521476
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Acetazolamide on Central Sleep Apnea Patients Receiving Medication for Opioid Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None