What this study is
Simplified from ClinicalTrials.govTesting referral to a comprehensive opioid management program (the UC San Diego Opioid Management Program) to see whether it steadies breathing during sleep in adults ages 18 to 75 who use opioids long-term and have sleep-disordered breathing. Some participants get usual care instead, and the research team does not prescribe opioids or require dose cuts.
Read the original summary from ClinicalTrials.gov
The REDUCE study will evaluate whether referral to a comprehensive opioid management program improves breathing stability during sleep in adults with chronic opioid use and sleep-disordered breathing.
This is a Phase II, single-center, randomized, controlled study. Participants will be randomly assigned to either usual care or referral to the UC San Diego Opioid Management Program. Participants referred to the program will receive individualized opioid and pain management from their treating clinician or designated opioid management provider. Treatment may include changes to opioid medications and other pain-management strategies when clinically appropriate. The research team will not prescribe opioids or direct opioid dose adjustments, and no opioid dose reductions are required by the study.
Participants will be followed for approximately 26 weeks. Study assessments will include overnight sleep studies, questionnaires, blood collection, psychomotor vigilance testing, and regular safety monitoring.
The primary objective is to determine whether comprehensive opioid management improves ventilatory stability compared with usual care.
What's being tested
- Comprehensive Opioid Management
Intervention · OTHER
Participants randomized to the Comprehensive Opioid Management group will be referred to the UC San Diego Opioid Management Program. Opioid management will be provided by the participant's treating clinician or designated opioid management provider using guideline-concordant clinical care. Treatment may include opioid dose adjustments, medication optimization, non-opioid pain therapies, behavioral interventions, and other pain-management strategies when clinically appropriate. The research team will not prescribe opioids or direct opioid dose adjustments. All treatment decisions will remain under the authority of the participant's treating clinician or designated opioid management provider and will be based solely on clinical judgment rather than research requirements.
- Usual Care
Intervention · OTHER
Participants randomized to the Usual Care group will continue opioid management with their existing treating clinician. Clinical management, including opioid prescribing, dose adjustments, and other pain-management decisions, will remain under the direction of the participant's treating clinician according to routine clinical practice.
Study details
- Official title
- Respiratory Effects of Dose Optimization Under Comprehensive Opioid Management (REDUCE)
- Sponsor
- University of California, San Diego
- Conditions
- Sleep-Disordered Breathing · Chronic Opioid Use
- Enrolling
- 68 people
- Starts
- 2026-12-01
- Est. completion
- 2031-12-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 18 to 75 years.
- Chronic opioid use for ≥3 months with a daily dose ≥20 mg oral morphine-equivalent (MEqD).
- Diagnosis of sleep-disordered breathing (SDB), defined as AASM-recommended apnea-hypopnea index (AHI3A) ≥5 events per hour on a qualifying sleep study. AHI3A includes hypopnea definition ≥30% airflow reduction lasting ≥10 seconds, accompanied by ≥3% SpO₂ desaturation or arousal.
- Ability and willingness to comply with all study procedures, including overnight polysomnography and follow-up.
- Ability to provide written informed consent.
You can't join if
- Known severe pulmonary disease (e.g., advanced chronic obstructive pulmonary disease) that, in the opinion of the investigator, may increase the risk of oxygen-induced hypercapnia.
- Unstable or clinically significant cardiopulmonary disease, including but not limited to decompensated heart failure, unstable angina, or clinically significant arrhythmia.
- Recent hospitalization (within the past 30 days) or anticipated need for hospitalization during the study period.
- Recreational or non-prescribed opioid use.
- Alcohol use exceeding 2 standard drinks per day or evidence of substance use disorder that may interfere with study participation.
- Presence of other sleep disorders or neurologic conditions that significantly affect breathing during sleep (e.g., neuromuscular disease), in the opinion of the investigator.
- Uncontrolled insomnia.
- Pregnancy or breastfeeding, or planning to become pregnant during the study period.
- Inability to tolerate study procedures, including overnight polysomnography.
- Inability to provide informed consent or comply with study procedures.
- Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with safe participation or interpretation of study results.
- Inability to safely participate in Comprehensive Opioid Management.
- Unstable or uncontrolled pain conditions.
- Recent significant changes in opioid regimen.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAltman Clinical and Translational Research Institute
La Jolla, California, United States
- Stacie Moore, CRT-SDS · Contact6197356727s3moore@health.ucsd.edu
- Pamela N DeYoung, RPSGT · Contact8582320343pdeyoung@health.ucsd.edu
- Jeremy Orr, MD · Principal investigator
Study team
Sponsor
University of California, San Diego
Study ID 815079
Principal investigator
Jeremy Orr, MD
University of California, San Diego
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.