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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Sanjay R Patel
Study ID
NCT06521476
Phase
PHASE2
Status
Recruiting
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Conditions

  • Central Sleep Apnea Comorbid With Opioid Use

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Acetazolamide — DRUG
    Oral acetazolamide 250 mg daily for 7 days
  • Placebo — DRUG
    Oral placebo daily for 7 days

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Oct 2025
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Elizabeth Stempkowski
[email protected]
412-648-9507
Sanjay R Patel, MD (PRINCIPAL_INVESTIGATOR)
Venkatesh Krishnamurthy, MD (SUB_INVESTIGATOR)
Tae Woo Park, MD (SUB_INVESTIGATOR)
Kristine Wilckens, PhD (SUB_INVESTIGATOR)

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University of Pittsburgh· Pittsburgh, PA