Managing Opioid Related Sleep Apnea With Acetazolamide

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Acetazolamide

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Use of opioids outside medical supervision (e.g. recreational use)

• Unable or unwilling to withhold any ongoing SDB treatment (e.g. CPAP) for the duration of the study

• Urgent need to initiate effective SDB therapy

• Chronic lung disease (other than well-controlled asthma)

• Active cardiac disease including heart failure, chest pain, or heart rhythm problems

• Neurological or developmental problems affecting breathing

• Major sleep disorders other than sleep apnea

• Chronic kidney disease

• Cirrhosis of the liver

• Active cancer treatment or limited life expectancy

• Psychiatric disease other than controlled mood disorders

• Use of diuretics, potassium supplementation, or medications that may affect potassium

• Allergy to study drug or related compounds including sulfa drugs

• Know electrolyte disturbances

• Hospitalized in the last 90 days or anticipated hospitalization within 3 months

• Alcohol use >2 standard drinks per day

• Presence of tracheostomy or artificial airway

• Prisoners

• Pregnancy or anticipating pregnancy in next 2 months, or nursing

• Unable or unwilling to provide informed consent

• Unable to follow study protocol