Managing Opioid Related Sleep Apnea With Acetazolamide (NCT06043830) | Clinical Trial Compass
CompletedPhase 2
Managing Opioid Related Sleep Apnea With Acetazolamide
United States39 participantsStarted 2023-10-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.