Read our disclaimer for details. Last Update Posted : December 5, Study Description. 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.
Oxycodone API powder mass of 30 mg , containing oxycodone hydrochloride 30 mg. Participants receive a single intranasal dose of placebo to match oxycodone API powder mass of 30 mg followed by a single intranasal dose of placebo to match manipulated oxycodone IR ADF mass of mg. Outcome Measures. The size of the participant's pupil will be measured in mm using a pupillometer. PCmin will be calculated.
Number of adverse events and number of participants with adverse events. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Participants have given written informed consent to participate. Female or male participants, aged 18 years to 55 years inclusive at the time of the Enrollment Visit. Body mass index between 20 kilograms per square meter and 32 kilograms per square meter inclusive, with a minimum body weight of 55 kilograms.
Participants must be in good health as determined by the medical history, physical and laboratory examinations and must not show any clinically significant findings as determined by lead electrocardiogram ECG , vital signs pulse rate, respiratory rate, systolic and diastolic blood pressure , oxygen saturation, body temperature, and safety laboratory parameters hematology, clinical chemistry, clotting, and urinalysis.
Female participants of childbearing potential must agree to use one of the acceptable contraceptive regimens listed below from at least 15 days prior to the first administration of IMP until at least 30 days after the last administration of IMP. For female participants of childbearing potential: Combined estrogen- and progestogen-containing hormonal contraception.
Progestogen-only hormonal contraception associated with inhibition of ovulation. An intra-uterine device hormone-free. An intra-uterine hormone releasing system. Bilateral tubal occlusion.
Double barrier methods i. Current opioid users who have used opioids for recreational non-therapeutic purposes, i. Participants who have intranasally insufflated drugs for recreational non-therapeutic purposes at least 3 times in the last 12 months before the Enrollment Visit.
Exclusion Criteria: Resting pulse rate below 50 beats per minute or above beats per minute. Resting systolic blood pressure below 90 mmHg or above mmHg. Resting diastolic blood pressure above 90 mmHg. Prolongation of the corrected QT interval Fridericia , i. Evidence for thyroid disease based on clinical and safety laboratory findings, including thyroid-stimulating hormone TSH. Any laboratory value from blood samples taken at the Enrollment Visit meeting the following criteria: Out-of-reference range value for serum creatinine or clotting parameter prothrombin international normalized ratio.
Exclusion range met for urinalysis or alanine transaminase, aspartate transaminase, alkaline phosphatase, total bilirubin, glucose fasted , gamma-glutamyl transferase, lactate dehydrogenase, potassium, total protein, sodium, calcium, hemoglobin, hematocrit, white blood cell count, or platelets.
Out-of-reference range value for any other safety laboratory parameter that is judged by the investigator to be clinically relevant. Positive or missing virus serology test for human immunodeficiency virus Type 1 or Type 2 antibodies and antigen, hepatitis B surface antigen, hepatitis B core antigen antibodies, or hepatitis C virus antibodies.
For female participants: positive or missing pregnancy test. Participant received an IMP or an investigational medical device in another clinical trial less than 30 days before the Enrollment Visit.
Depending on the nature of the previous IMP or investigational medical device, a longer washout may be needed. Diseases or conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. The sooner you seek treatment, the greater the chances for a successful long-term recovery.
She has always had a passion for literature and the written word. Upon graduation, Jena found her purpose in educating the public on addiction and helping those that struggle with substance dependency find the best treatment options available.
All of the information on this page has been reviewed and verified by a certified addiction professional. Theresa is also a Certified Professional Life Coach and volunteers at a local mental health facility helping individuals who struggle with homelessness and addiction. Theresa is a well-rounded clinician with experience working as a Primary Addiction Counselor, Case Manager and Director of Utilization Review in various treatment centers for addiction and mental health in Florida, Minnesota, and Colorado.
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Crushing and snorting Oxycodone can expose the body to much higher doses than a prescription would intend. This type of misuse can lead to deadly effects:. The nose is a sensitive organ, and snorting drugs regularly can result in serious health consequences. Oftentimes the substance being inhaled aggravates the soft tissues and can cause infections throughout the nasal passage. Many people who habitually snort Oxycodone and other substances suffer from lung irritation and infections.
Sinus infections and other respiratory diseases are also very common among those who regularly snort Oxycodone. Even if the drugs are sterile, snorting off a dirty surface, through a dirty straw, or through a rolled-up bill could carry unwanted contaminants and cause further infection.
Prescription Opioid abuse forms the backbone of what is now the Opioid epidemic. Oxycodone is a serious substance not to be taken without a prescription from a doctor or pharmacist. If you or a loved one struggles with Oxycodone addiction, please know that help is available. Compassionate treatment providers are available to help you take the first step toward recovery. There are many different forms of addiction.
Get the information you need to help you overcome yours. Michael Muldoon. Dryden, Cicero et al. Lofwall et al. Moorman-Li et al. Call Calls to numbers on a specific treatment center listing will be routed to that treatment center.
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