Sleep-Disordered BreathingREDUCENCT07923721
Comprehensive Opioid Management and Breathing During Sleep
A study testing Comprehensive Opioid Management in people with Sleep-Disordered Breathing and Chronic Opioid Use, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep-Disordered Breathing, Chronic Opioid Use
- What is being tested?
- Comprehensive Opioid Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Stacie Moore, CRT-SDS, 6197356727, s3moore@health.ucsd.edu
Pamela N DeYoung, RPSGT, 8582320343, pdeyoung@health.ucsd.edu
About this study
Official title: Respiratory Effects of Dose Optimization Under Comprehensive Opioid Management (REDUCE)
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Sleep-Disordered Breathing, Chronic Opioid Use
- Being tested
- Comprehensive Opioid Management, Usual Care
- Keywords
- Sleep-Disordered Breathing, Chronic Opioid Use, Comprehensive Opioid Management, Ventilatory Stability, Ventilatory Instability, Loop Gain, Opioid Management, Polysomnography, Apnea-Hypopnea Index, Respiratory Pattern Variability
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Opioid ManagementOther
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 CareOther
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 group | Role | What they receive |
|---|---|---|
| Comprehensive Opioid Management | Experimental | 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. Receives: Other: Comprehensive Opioid Management |
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 26
Secondary outcomes (1)
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.
Measured: Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, controlled, parallel-group trial comparing Comprehensive Opioid Management with usual care over approximately 26 weeks in adults with chronic opioid use and sleep-disordered breathing.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeremy Orr, M.D., University of California, San Diego
- Investigators
- Jeremy Orr, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923721
- Sponsor's protocol ID
- 815079
- Other IDs
- R01HL179220
- Acronym
- REDUCE
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Effects of Dose Optimization Under Comprehensive Opioid Management (REDUCE)
- ClinicalTrials.gov ID
- NCT07923721
- Acronym / sponsor ID
- REDUCE / 815079
- Conditions
- Sleep-Disordered Breathing, Chronic Opioid Use
- Keywords
- Sleep-Disordered Breathing, Chronic Opioid Use, Comprehensive Opioid Management, Ventilatory Stability, Ventilatory Instability, Loop Gain, Opioid Management, Polysomnography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized, controlled, parallel-group trial comparing Comprehensive Opioid Management with usual care over approximately 26 weeks in adults with chronic opioid use and sleep-disordered breathing.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Opioid Management | Experimental | Other: Comprehensive Opioid ManagementParticipants 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. |
| Usual Care | Active comparator | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Opioid ManagementParticipants 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. | Other | Comprehensive Opioid Management |
| Usual CareParticipants 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. | Other | Usual Care |
Primary outcome
Change in Ventilatory Instability (Loop Gain)
Time frame: Baseline to Week 26
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.
1 secondary outcome
Change in Apnea-Hypopnea Index (AHI)
Time frame: Baseline to Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy Orr, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Opioid Management in people with Sleep-Disordered Breathing and Chronic Opioid Use, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacie Lee Moore, CRT-SDS (6197356727, s3moore@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ventilatory Instability (Loop Gain) (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.