Using acetazolamide to manage sleep apnea in patients on opioids

Managing Opioid Related Sleep Apnea With Acetazolamide

This study is testing if a medication called acetazolamide can help people who use opioids and have sleep apnea breathe better at night.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Diego (other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06043830 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of acetazolamide in improving sleep-disordered breathing (SDB) in patients who are chronic opioid users and have been diagnosed with SDB. Participants will be randomized to receive either acetazolamide or a placebo for one week, during which their symptoms and apnea-hypopnea index will be monitored. The study aims to provide an alternative treatment option for those who cannot tolerate CPAP devices. Data collected will inform future long-term studies on managing SDB in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have chronic pain, are using opioids daily for more than three months, and have a diagnosed apnea-hypopnea index of 10 events/hour or more.

Not a fit: Patients with chronic lung or kidney disease, heart failure, or those unable to withhold current SDB treatments will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for managing sleep apnea in patients who rely on opioids for chronic pain.

How similar studies have performed: While the approach of using acetazolamide for SDB is novel in this context, similar studies have explored alternative treatments for sleep apnea with varying degrees of success.

Eligibility 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

Where this trial is running

San Diego, California

• University of California San Diego — San Diego, California, United States (RECRUITING)

Study contacts

• Principal investigator: Jeremy Orr, MD — UC San Diego
• Study coordinator: Jeremy Orr, MD

Conditions: Sleep-Disordered Breathing, Obstructive Sleep Apnea, Central Sleep Apnea, Chronic Pain, Opioid Use, Sleep apnea, Opioid, Lung