Managing Opioid Related Sleep Apnea With Acetazolamide

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called acetazolamide can help improve sleep-related breathing problems in patients who have chronic pain and use opioids. These breathing issues, known as sleep-disordered breathing, can make it hard to breathe properly during sleep and may not improve with the usual treatment called CPAP, which is a device that helps keep airways open. The trial will compare the effects of acetazolamide over one week to a placebo (a sugar pill) to see if it can reduce these breathing difficulties and improve overall symptoms.

To participate in this study, individuals need to be at least 18 years old, have chronic pain, and have been using opioids daily for more than three months. They should also have a certain level of breathing problems during sleep. Anyone with specific health conditions, such as severe lung or heart issues, or those who are pregnant or nursing, will not be eligible. Participants can expect to take the medication or placebo for one week and will be monitored for any changes in their sleep and breathing patterns. This study is important as it could lead to new treatment options for people who struggle with sleep problems related to opioid use.

Gender

ALL

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