University of California, San Diego
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…
Inclusion Criteria: * 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. Exclusion Criteria: * K…
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.