An interventional study of Comprehensive Opioid Management and Usual Care in Sleep-Disordered Breathing and Chronic Opioid Use, sponsored by University of California, San Diego. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
Chronic opioid use is associated with sleep-disordered breathing, including obstructive and central sleep apnea. Opioids can alter respiratory drive and ventilatory control, contributing to breathing instability, oxygen desaturation, nocturnal hypercapnia, and sleep fragmentation.
The REDUCE study (Respiratory Effects of Dose Optimization Under Comprehensive Opioid Management) is a Phase II, single-center, randomized, controlled, parallel-group, open-label trial conducted at the University of California, San Diego. The study is designed to evaluate the effects of referral to the UC San Diego Opioid Management Program compared with usual care on ventilatory stability and sleep-disordered breathing physiology in adults with chronic opioid use.
Eligible participants will be adults aged 18 to 75 years with chronic opioid use for at least three months, a daily opioid dose of at least 20 mg oral morphine equivalents, and sleep-disordered breathing defined by an apnea-hypopnea index (AHI3A) of at least five events per hour.
Participants will be randomized in a 1:1 ratio to one of two study groups: Usual Care or Comprehensive Opioid Management.
Participants assigned to Usual Care will continue opioid and pain management under the direction of their existing treating clinician according to routine clinical practice.
Participants assigned to Comprehensive Opioid Management will be referred to the UC San Diego Opioid Management Program for individualized, guideline-concordant clinical care. Management may include opioid dose adjustments, medication optimization, non-opioid pain therapies, behavioral interventions, and other pain-management strategies when clinically appropriate. All opioid prescribing and treatment decisions will remain under the authority of the treating clinician or designated opioid management provider. The research team will not prescribe opioids, independently direct opioid dose adjustments, or require a protocol-specified opioid taper.
Participants will complete screening and baseline assessments, including medical and sleep history, physical examination, medication review, questionnaires, opioid use assessment, and blood collection. A baseline polysomnography (PSG) will be performed if a qualifying PSG has not been completed within the previous eight weeks or if a clinically significant change in medical or sleep-related status has occurred.
Following baseline assessments and randomization, participants will enter a 26-week follow-up period. During this period, participants will complete twice-weekly text-message safety check-ins and twice-monthly telephone outreach. Safety monitoring will assess opioid use, medication changes, withdrawal symptoms, pain control, mood symptoms including suicidality, respiratory symptoms, adverse events, emergency care utilization, and study adherence.
An interim assessment will occur at approximately Week 12 and will include medication and opioid use review, adverse event assessment, and study questionnaires.
At approximately Week 26, all participants will complete an end-of-study assessment, including overnight polysomnography, questionnaires, opioid use assessment, blood collection, and morning psychomotor vigilance testing. Sleep studies will assess respiratory events, ventilatory instability, oxygen saturation, and transcutaneous carbon dioxide levels.
The primary endpoint is the change in ventilatory instability as measured by loop gain from baseline to Week 26. Secondary endpoints include apnea-hypopnea index (AHI), flow-based apnea-hypopnea index (AHIflow), respiratory pattern variability, oxygen saturation metrics including time spent with SpO2 below 90%, transcutaneous carbon dioxide (TcCO2), psychomotor vigilance testing, patient-reported sleep and symptom measures, pain-related outcomes, and opioid exposure.
The study will compare changes in ventilatory stability and related physiological and clinical outcomes between participants receiving usual care and those referred for Comprehensive Opioid Management over the 26-week study period.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's planned enrollment of 68 is above the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
Unstable or 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the Comprehensive Opioid Management arm will receive individualized opioid and pain-management care under the supervision of the participant's treating clinician and/or the UC San Diego Opioid Management Program. Comprehensive Opioid Management will be conducted in accordance with clinical practice guidelines and may include changes to opioid therapy, medication management, and other pain-management strategies, as clinically appropriate. Opioid prescribing decisions remain with the participant's treating or prescribing clinician or the UC San Diego Opioid Management Program. The research team does not prescribe opioids.
Other: Comprehensive Opioid Management
Participants randomized to the usual care arm will continue opioid management under the direction of their treating clinician and will not receive protocol-directed Comprehensive Opioid Management.
Other: Usual Care
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.
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.
Change in Ventilatory Instability (Loop Gain)
Change in ventilatory instability as assessed by polysomnographic measures, including loop gain. The change from baseline to Week 26 will be compared between the Comprehensive Opioid Management and Usual Care groups.
Time frame: Baseline to Week 26
Change in Apnea-Hypopnea Index (AHI)
Change in sleep-disordered breathing severity as measured by the apnea-hypopnea index (AHI) using polysomnography. Changes from baseline to Week 26 will be compared between the Comprehensive Opioid Management and Usual Care groups.
Time frame: Baseline to Week 26
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The individual participant data (IPD) sharing plan has not yet been finalized. Any future sharing of de-identified participant data will be subject to participant consent, applicable institutional policies, IRB requirements, and NIH data-sharing requirements.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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