Acetazolamide in Central Sleep Apnea Patients Using Medication for Opioid Use Disorder

NCT ID: NCT06521476

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-02-29

Brief Summary

Patients with opioid use disorder treated with either methadone or buprenorphine are at risk of developing central sleep apnea (CSA) from these medications. Investigators will conduct a mechanistic trial using acetazolamide, a medicine known to improve CSA in other settings, to determine if acetazolamide can improve CSA due to medication for opioid use disorder and whether this leads to physiologic changes that might lead to reduced drug craving. Patients treated with medication for opioid use disorder and who have central sleep apnea will be randomized to treatment with acetazolamide or matching placebo for 7 days. At the end of the 7 days, they will undergo an overnight sleep study to assess the impact on breathing during sleep as well as sleep quality. In addition, measures of sympathetic tone, anxiety, arousal, cognition, and drug craving will be measured to determine if treatment of CSA with acetazolamide can produce physiologic changes that might contribute to improved health.

Detailed Description

Medications used to treat opioid use disorder (MOUD) such as methadone and buprenorphine have been found to cause central sleep apnea (CSA), but the clinical ramifications are unclear. It has been hypothesized that the sleep fragmentation and intermittent hypoxemia caused by CSA from MOUD may lead to sympathetic activation, nocturnal arousal, increased anxiety, and cognitive impairment that may in turn increase drug craving and drug relapse. This mechanistic study will evaluate the potential adverse effect of CSA in patients on MOUD by evaluating the impact of acetazolamide to improve CSA and thereby lead to downstream physiologic changes in measures of sleep quality, sympathetic tone, nocturnal arousal, anxiety, cognitive functioning, and drug craving.

Eligible individuals will undergo an overnight research visit including overnight polysomnography, assessments of autonomic tone, sleep quality, nocturnal arousal, emotional distress, cognitive testing, and drug craving. Individuals with opioid-induced CSA will be randomized into a parallel-arm trial of acetazolamide vs. placebo with overnight research visit for outcome assessment at 7 days.

Conditions

Central Sleep Apnea Comorbid With Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acetazolamide

All participants in this group will receive one acetazolamide 250 mg pill in the evening for 7 days.

Group Type: EXPERIMENTAL

Acetazolamide

Intervention Type: DRUG

Oral acetazolamide 250 mg daily for 7 days

Placebo

All participants in this group will receive one matching placebo pill in the evening for 7 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo daily for 7 days

Interventions

Acetazolamide

Oral acetazolamide 250 mg daily for 7 days

Intervention Type: DRUG

Placebo

Oral placebo daily for 7 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea.

Exclusion Criteria

• Sleep-related Hypoventilation.
• Other causes of Central Sleep Apnea besides Opioid Use.
• Pregnancy.
• Contraindications for Acetazolamide.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Sanjay R Patel

OTHER

Sponsor Role: lead

Responsible Party

Sanjay R Patel

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sanjay R Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Stempkowski

Role: CONTACT

stempkowskiem@upmc.edu

412-648-9507

Julia Sherman

Role: CONTACT

shermanj2@upmc.edu

412-383-9469

Facility Contacts

Elizabeth Stempkowski

Role: primary

stempkowskiem@upmc.edu

412-648-9507

Other Identifiers

R01DA059465

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23100016

Identifier Type: -

Identifier Source: org_study_id