Managing Opioid Related Sleep Apnea With Acetazolamide

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. However, this device is not effective or tolerated in all individuals. The goal of this study is to examine whether a medication called acetazolamide can improve SDB, as an alternative to CPAP treatment. The investigators will measure the improvement in SDB, as well as any change in symptoms, during a 1 week treatment with acetazolamide compared with 1 week of placebo (sugar pill). This study will help to provide data for longer term studies of treatment for SDB in patients who use opioids.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18+

• Chronic pain

• Chronic opioid use (daily use for \>3 months duration) with \>/= 20 oral Morphine Equivalent Dose (MEqD) per day

• Apnea-hypopnea index \>/= 10 events/hr (hypopnea definition: ≥ 3% desaturation or arousal criteria per American Academy of Sleep Medicine 2012 scoring rules)

Locations
United States
California
University of California San Diego
RECRUITING
San Diego
Contact Information
Primary
Jeremy Orr, MD
sleepresearch@health.ucsd.edu
858-246-2183
Time Frame
Start Date: 2023-10-18
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 34
Treatments
Experimental: Placebo followed by acetazolamide
Subjects will start with a 1-week PLACEBO regimen Day 1-7: Placebo (matching Acetazolamide) nightly~After a 2 week wash-out period, subjects will then cross-over to a 1-week ACETAZOLAMIDE regimen:~Day 1-7: Acetazolamide 500 mg nightly
Experimental: Acetazolamide followed by placebo
Subjects will start with a 1-week ACETAZOLAMIDE regimen Day 1-7: Acetazolamide 500 mg nightly~After a 2 week wash-out period, subjects will then cross-over to a 1-week PLACEBO regimen:~Day 1-7: Placebo (matching Acetazolamide) nightly
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov