Managing Opioid Related Sleep Apnea With Acetazolamide

NCT06043830 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 201743.2K23HL151880
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep-Disordered Breathing; Obstructive Sleep Apnea; Central Sleep Apnea; Chronic Pain; Opioid Use

Keywords

Sleep apnea; Opioid; Lung

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index, NREM Supine

  The AHI is a measure of sleep apnea severity and is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a \>=3% desaturation or cortical arousal) per hour of sleep. For the primary outcome, the study will evaluate the AHI during non-rapid eye movement sleep in the supine position.

  1 week

Secondary Outcomes (1)

• Apnea-hypopnea index, Total

  1 week

Other Outcomes (5)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance

  1 week

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment

  1 week

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Behavior

  1 week

Study Arms (2)

Placebo followed by acetazolamide

EXPERIMENTAL

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

Drug: Acetazolamide; Other: Placebo

Acetazolamide followed by placebo

EXPERIMENTAL

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

Drug: Acetazolamide; Other: Placebo

Interventions

Acetazolamide DRUG

Acetazolamide 250 mg 2 capsules by mouth nightly

Acetazolamide followed by placebo; Placebo followed by acetazolamide

Placebo OTHER

Sugar capsule manufactured to match encapsulated Acetazolamide 2 capsules by mouth nightly

Acetazolamide followed by placebo; Placebo followed by acetazolamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Chronic Pain

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeremy Orr, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: October 18, 2023
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)