Recruiting
Phase 2

Acetazolamide with Medication

Sponsor:

Sanjay R Patel

Code:

NCT06521476

Conditions

Central Sleep Apnea Comorbid With Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acetazolamide

Placebo

Study Details

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.

Conditions

Central Sleep Apnea Comorbid With Opioid Use

Study ID

NCT06521476

Start date

Sep 30, 2025

Status verified date

Jun, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acetazolamide

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

placebo comparator: Placebo

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

Interventions

Acetazolamide

Oral acetazolamide 250 mg daily for 7 days

Placebo

Oral placebo daily for 7 days

Primary outcome measure

  • Central Apnea Index (CAI) [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

Sanjay R Patel, MD

More Information

Sponsor

Sanjay R Patel

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Acetazolamide
  • Opioid Use Disorder
  • Medication for opioid use disorder (MOUD)
  • Methadone
  • Buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanjay R Patel on 2026-06-25.