Obesity & OverweightPhase 2ORCHIDNCT07902752
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
A Phase 2 study testing Intranasal Oxytocin 40 i.u. in people with Obesity & Overweight and Respiratory Depression, run by George Washington University.
Trial summary
Drug overdose is a national crisis. The primary cause of death associated with opioids is opioid-induced respiratory depression. Naloxone (Narcan) which is the first line of defense for opioid overdose can reverse OIRD (Opioid-Induced Respiratory Depression), but in post-operative patients it will abolish pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Respiratory Depression, Intranasal Drug Administration
- What is being tested?
- Intranasal Oxytocin 40 i.u.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2027to 14 Jul 2030
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- BMI ≥ 35 kg/m2
- Scheduled or to be scheduled for bariatric surgery
Who cannot join
- OSA patients on CPAP therapy
- Chronic opioid use (daily use of opioids)
- Unstable cardiovascular disease (decompensated CHF, myocardial infarction or revascularization procedures, and unstable arrhythmias)
- Uncontrolled hypertension (BP > 190/110)
- Chronic Obstructive Pulmonary Disease or another intrinsic lung disease
- Chronic sinusitis requiring surgical treatment (except septal deviation)
Show all 17Show fewer
- Chronic muscle weakness
- Chronic daytime hypoxemia (PaO2 < 70) or hypercapnia (PaCO2 ≥ 45 mmHg)
- Chronic supplemental oxygen use
- Renal failure on dialysis
- Diabetes mellitus requiring insulin
- Diabetic neuropathy
- Previous surgery for OSA (laser-assisted uvulopalatoplasty, LAUP or uvulopalatopharyngoplasty)
- Hypoglossal nerve stimulator
- Allergy to oxytocin
- Pregnancy
- Premenopausal women, who are not on birth control
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Eduard R Research Manager, Anesthesia and Critical Care Medicine contact
About this study
Official title: A Prospective, Single-center, Randomized, Blinded Study to Evaluate the Efectiveness of Intranasal Oxytocin in Prevention of Opioid Induced Postoperative Sleep Apnea in Bariatric Surgery Patients
Drug overdose is a national crisis. The primary cause of death associated with opioids is opioid-induced respiratory depression. Naloxone (Narcan) which is the first line of defense for opioid overdose can reverse OIRD (Opioid-Induced Respiratory Depression), but in post-operative patients it will abolish pain control. There are no medications that can prevent OIRD. Pre-clinical studies provided evidence that intranasal (administered via a nasal spray) oxytocin may prevent and treat OIRD without interfering with pain control.
Read the detailed description
Opioid medications are commonly administered both during and after surgery for pain control and may cause a decrease in respirations and have a potential to cause a collapse of the upper respiratory tract. After surgery, bariatric surgery patients have a higher risk for respiratory complications than other surgical patients. Unrecognized opioid-induced respiratory depression (OIRD) in bariatric patients can lead to profound hypoventilation (low breathing rate), hypercarbia (increased carbon dioxide levels in the bloodstream), hypoxemia (low oxygen levels in the bloodstream), brain damage, and death. Our compelling animal studies suggest that oxytocin reverses OIRD by increasing survival, increasing respiratory rate and reducing the incidence of apneas (when respirations stop partially or completely). We have already shown that oxytocin is effective for treatment of obstructive sleep apnea patients, decreasing the duration of the apnea events and the severity of hypoxemia, and increasing respiratory rate. In this study, we are studying efficacy of oxytocin for OIRD prevention in bariatric patients during postoperative recovery in a double-blinded placebo-controlled randomized clinical trial called ORCHID (Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs).
- Conditions
- Obesity & Overweight, Respiratory Depression, Intranasal Drug Administration, Oxytocin, Bariatric Surgery
- Being tested
- Intranasal Oxytocin 40 i.u., Intranasal Placebo Spray
- Keywords
- ORCHID, Obesity hypoventilation syndrome, intranasal oxytocin, Opioid induced respiratory depression, OIRD
- Medical subject headings
- Obesity, Overweight, Respiratory Insufficiency, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Oxytocin 40 i.u.Drug
Intranasal oxytocin dose of 40 international units
Intranasal Placebo SprayDrug
This is a placebo comparator intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Oxytocin | Experimental | Intranasal oxytocin administered once after index surgery Receives: Drug: Intranasal Oxytocin 40 i.u. |
| Intranasal Placebo | Placebo comparator | Intranasal placebo administered once after index surgery Receives: Drug: Intranasal Placebo Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Hypopnea Events
The number of postoperative hypopnea events
Measured: 2.5 hours after index surgery
Postoperative Apnea Events
The number of postoperative apnea events
Measured: 2.5 hours after index surgery
Oxygen Levels
Oxygen desaturation index
Measured: 2.5 hours after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 May 2027 (estimated)
- Primary completion14 Jul 2029 (estimated)
- Study completion14 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Vsevolod Polotsky, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902752
- Sponsor's protocol ID
- ORCHID-GWU-1
- Other IDs
- UG3DA062506-02
- Acronym
- ORCHID
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized, Blinded Study to Evaluate the Efectiveness of Intranasal Oxytocin in Prevention of Opioid Induced Postoperative Sleep Apnea in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT07902752
- Acronym / sponsor ID
- ORCHID / ORCHID-GWU-1
- Conditions
- Obesity & Overweight, Respiratory Depression, Intranasal Drug Administration, Oxytocin, Bariatric Surgery
- Keywords
- ORCHID, Obesity hypoventilation syndrome, intranasal oxytocin, Opioid induced respiratory depression, OIRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 May 2027 (estimated)
- Primary completion
- 14 Jul 2029 (estimated)
- Study completion
- 14 Jul 2030 (estimated)
- First posted
- 29 Oct 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.
Drug overdose is a national crisis. The primary cause of death associated with opioids is opioid-induced respiratory depression. Naloxone (Narcan) which is the first line of defense for opioid overdose can reverse OIRD (Opioid-Induced Respiratory Depression), but in post-operative patients it will abolish pain control. There are no medications that can prevent OIRD. Pre-clinical studies provided evidence that intranasal (administered via a nasal spray) oxytocin may prevent and treat OIRD without interfering with pain control.
Detailed description
Opioid medications are commonly administered both during and after surgery for pain control and may cause a decrease in respirations and have a potential to cause a collapse of the upper respiratory tract. After surgery, bariatric surgery patients have a higher risk for respiratory complications than other surgical patients. Unrecognized opioid-induced respiratory depression (OIRD) in bariatric patients can lead to profound hypoventilation (low breathing rate), hypercarbia (increased carbon dioxide levels in the bloodstream), hypoxemia (low oxygen levels in the bloodstream), brain damage, and death. Our compelling animal studies suggest that oxytocin reverses OIRD by increasing survival, increasing respiratory rate and reducing the incidence of apneas (when respirations stop partially or completely). We have already shown that oxytocin is effective for treatment of obstructive sleep apnea patients, decreasing the duration of the apnea events and the severity of hypoxemia, and increasing respiratory rate. In this study, we are studying efficacy of oxytocin for OIRD prevention in bariatric patients during postoperative recovery in a double-blinded placebo-controlled randomized clinical trial called ORCHID (Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Oxytocin | Experimental | Drug: Intranasal Oxytocin 40 i.u.Intranasal oxytocin administered once after index surgery |
| Intranasal Placebo | Placebo comparator | Drug: Intranasal Placebo SprayIntranasal placebo administered once after index surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- BMI ≥ 35 kg/m2
- Scheduled or to be scheduled for bariatric surgery
Key exclusion criteria (17 listed)
- OSA patients on CPAP therapy
- Chronic opioid use (daily use of opioids)
- Unstable cardiovascular disease (decompensated CHF, myocardial infarction or revascularization procedures, and unstable arrhythmias)
- Uncontrolled hypertension (BP > 190/110)
- Chronic Obstructive Pulmonary Disease or another intrinsic lung disease
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 |
|---|---|---|
| Intranasal Oxytocin 40 i.u.Intranasal oxytocin dose of 40 international units | Drug | Intranasal Oxytocin |
| Intranasal Placebo SprayThis is a placebo comparator intranasal spray | Drug | Intranasal Placebo |
Primary outcome
Postoperative Hypopnea Events
Time frame: 2.5 hours after index surgery
The number of postoperative hypopnea events
Postoperative Apnea Events
Time frame: 2.5 hours after index surgery
The number of postoperative apnea events
Oxygen Levels
Time frame: 2.5 hours after index surgery
Oxygen desaturation index
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 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity & Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Eduard R Research Manager, Anesthesia and Critical Care Medicine contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Oxytocin 40 i.u. in people with Obesity & Overweight and Respiratory Depression, run by George Washington University.
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 3 inclusion and 17 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eduard R Research Manager, Anesthesia and Critical Care Medicine (2022038960, eshaykhinurov@mfa.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Hypopnea Events (time frame: 2.5 hours after index surgery). The study lists 3 primary outcomes in all. 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 29 Oct 2026.