A Phase 2 interventional study of Intranasal Oxytocin 40 i.u. and Intranasal Placebo Spray in Obesity & Overweight, Respiratory Depression and Intranasal Drug Administration, sponsored by George Washington University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by George Washington University · Phase 2, Interventional, and Prevention
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.
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).
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 100 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) 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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intranasal oxytocin administered once after index surgery
Drug: Intranasal Oxytocin 40 i.u.
Intranasal placebo administered once after index surgery
Drug: Intranasal Placebo Spray
Intranasal oxytocin dose of 40 international units
This is a placebo comparator intranasal spray
Postoperative Hypopnea Events
The number of postoperative hypopnea events
Time frame: 2.5 hours after index surgery
Postoperative Apnea Events
The number of postoperative apnea events
Time frame: 2.5 hours after index surgery
Oxygen Levels
Oxygen desaturation index
Time frame: 2.5 hours after index surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2027; primary completion for Jul 2029, 25 months later.
Of 132 non-industry phase 2 interventional studies under Obesity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's planned 25 months is below that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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