When individuals misuse oxycodone by insufflation, they increase the likelihood of significant medical or psychological problems like overdose or damage to the nasal passageway. Potential overdose is an immediate risk of snorting oxycodone, particularly when taken in excessive amounts. When someone takes more than the intended dose, it can result in severe respiratory depression, where breathing becomes dangerously slow or stops completely.
Other potential signs of an oxycodone overdose include:. When someone abuses oxycodone by insufflation over a long period of time, they may cause permanent damage to their nasal passageway, including inflammation, infection and potential changes to the internal structures of the nose.
Another potential danger of snorting oxycodone is that they were designed to be taken orally, not nasally. So the pills themselves may contain contaminants that may not be received well by the nasal membrane.
At times, the casings on the pills may get stuck in the nasal passageway and cause infection. Snorting oxycodone fast tracks the effects of the opioid drug on the central nervous system CNS , resulting in feelings of euphoria.
This is especially true of the extended-release version of the drug. When someone snorts oxycodone, the nasal membrane quickly absorbs the contents of the pill into the bloodstream which causes them to feel high.
It is a common misconception that snorting is the fastest way to achieve this high. In reality, when drugs are snorted they must pass through the nose, to the heart and lungs, then onto the rest of the body. Whereas when someone smokes the drug, it goes straight to the lungs. The issue with snorting is that the nose is not designed to absorb that many powders, it is designed to filter out particles that should not be in the body. With repeated abuse, the mucous membrane can become worn down and damaged.
When oxycodone is snorted, side effects of the drug can include sudden, a dangerous drop in blood pressure, seizures, slowed breathing, cardiac arrest, and potential death.
Some additional effects of oxycodone may include:. After long-term misuse of oxycodone, individuals can experience a dangerously decreased level of testosterone. Other long-term effects of oxycodone include excessive sweating, swelling in the arms and legs and chronic constipation.
One study showed that individuals can suffer from nasopharyngeal necrosis after chronically snorting oxycodone. This condition is associated with severe tissue destruction, causing a defect in the soft palate roof of the mouth. Long-term misuse of oxycodone can also result in immunosuppression or a general weakening of the immune system. Possible effects of opioid-induced immunosuppression have been reported to include susceptibility to infection, increased risk of cancer, and an increased risk of HIV infection in drug abusers.
The Qualification Phase includes a naloxone challenge test to verify that participants are not opioid-dependent and a drug discrimination test to determine whether or not participants are able to distinguish intranasally administered active drug from placebo.
Participants will be randomized to receive a single intranasal dose each of oxycodone active pharmaceutical ingredient API and matching placebo in a double-blind manner. The total mass of each single dose will be 30 milligrams.
Participants who successfully complete the Qualification Phase are eligible to be included in the Treatment Phase. During the Treatment Phase, participants will receive test product, comparator, and placebo following a randomized, double-blind, double-dummy, 3-way crossover design. A single dose of a treatment is defined as insufflation of single doses of the 2 applicable IMPs in quick succession.
The 2 applicable IMPs must be insufflated in the following pre-defined order. The total mass of each single dose of treatment will be milligrams. The millimeter mm bipolar VAS is anchored in the center with a neutral anchor of "neither like nor dislike" score of 50 mm , to the left with "strong disliking" score of 0 mm and to the right with "strong liking" score of mm. Area under the plasma concentration-time curve of oxycodone from time point 0 to t AUC0-t [ Time Frame: pre-dose and at 0.
Area under the plasma concentration-time curve of oxycodone from time point 0 to infinity AUC [ Time Frame: pre-dose and at 0. The mm unipolar VAS is anchored to the left with "not at all" score of 0 mm and to the right with "extremely" score of The mm bipolar VAS is anchored in the center with a neutral anchor of "neither like nor dislike" score of 50 mm , to the left with "strong disliking" score of 0 mm and to the right with "strong liking" score of mm.
The mm bipolar VAS is anchored in the center with a neutral anchor of "neutral" score of 50 mm , to the left with "definitely not" score of 0 mm and to the right with "definitely so" score of mm. The mm unipolar VAS, is anchored to the left with "not at all" score of 0 mm and to the right with "extremely" score of The mm bipolar VAS is anchored in the center with a neutral anchor of "neither easy nor difficult" score of 50 mm , to the left with "very difficult" score of 0 mm and to the right with "very easy" score of mm.
The mm bipolar VAS is anchored in the center with a neutral anchor of "neither pleasant nor unpleasant" score of 50 mm , to the left with "very unpleasant" score of 0 mm and to the right with "very pleasant" score of mm. Pupillometry parameter: Apparent minimum post dose pupil diameter PCmin [ Time Frame: pre-dose and at 0. The same eye for each participant will be used for all measurements throughout the trial. Measurements will be collected under mesopic lighting conditions.
Pupillometry parameter: The area over the curve to 1 hour relative to the baseline PAOChour [ Time Frame: Baseline up to 1 hour ] The size of the participant's pupil will be measured in mm using a pupillometer. Pupillometry parameter: The area over the curve to 8 hours relative to the baseline PAOChours [ Time Frame: Baseline up to 8 hours ] The size of the participant's pupil will be measured in mm using a pupillometer. Talk with your doctor and family members or friends about deciding to join a study.
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All female participants are considered to be of childbearing potential unless they have undergone hysterectomy or bilateral oophorectomy or have been postmenopausal for at least 12 months i. Any laboratory value from blood samples taken at the Enrollment Visit meeting the following criteria:.
Exclusion criteria on Day -1 of the Qualification Phase. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
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FDA Resources. Arms and Interventions. Placebo to match oxycodone API powder mass of 30 mg. Participants receive a single intranasal dose of oxycodone API powder mass of 30 mg, containing oxycodone hydrochloride 30 mg followed by a single intranasal dose of placebo to match manipulated oxycodone IR ADF mass of mg.
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