Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation

Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation

Publication date: Mar 17, 2020

Opioids can decrease breathing and co-administration of benzodiazepines with opioids can further decrease breathing. It is unknown whether certain other drugs also decrease breathing when co-administered with opioids. The objective of this study is to determine whether certain drugs combined with an opioid decrease breathing compared to breathing with an opioid alone. In order to assess this, this study will utilize the Read Rebreathing method, where study participants breathe increased levels of oxygen and carbon dioxide. The increased levels of carbon dioxide cause the study participants to increase breathing. This increased breathing response can be decreased by opioids and benzodiazepines, and potentially other drugs. Using this procedure, low doses of opioids or benzodiazepines can be administered that have minimal-to-no effects on breathing when study participants are going about normal activities breathing room air, however breathing increases less than expected as carbon dioxide levels are increased. This study includes three parts: A Lead-In Reproducibility Phase and two main parts (Part 1 and Part 2). The Lead-In Reproducibility Phase will measure the variability between study participants and between repeated uses of the method in the same study participant within a day and between days. Part 1 will study an opioid alone, benzodiazepine alone, and their combination to show the methodology will detect changes in breathing at low doses of the drugs that are known to affect breathing. Part 2 will assess whether two drugs, selected due to their effects on breathing in a nonclinical model, decrease the breathing response when combined with an opioid compared to when an opioid is administered alone.

Concepts Keywords
Acetaminophen Inadequate gas exchange
Air Alcohol xanthine products
Alcohol G cancer
Allergies Allergies
Antibodies Respiratory ventilatory depression
Antibody True respiratory depression
Antigen Clinically significant disorder
Aspirin Oral contraceptives
Benzodiazepine Birth control
Benzodiazepines Psychoactive drugs
Birth Control RTT
Blood Euphoriants
Body Mass Morphinans
Caffeine Oxycodone
Cancer Opioid
Carbon Dioxide Hypoventilation
Chemistry Midazolam
Chewing Tobacco Benzodiazepine
Chocolate Nitrazepam
Clinical Laboratory Antibodies
CO2
Coffee
Cola
Crossover
CYP2D6
Cytochrome P450
Depression
Dimes
DSM
ECG
Electrocardiogram
FDA
Gas Exchange
Generalized Anxiety Disorder
Grapefruit
Grapefruit Juice
Hematology
Hepatic
Hepatitis
HIV
Hypercapnia
Hypercapnic
Hypoventilation
Immunodeficiency
Inadequate
Informed Consent
Intubation
Investigational Drug
IRB
Lactating
Midazolam
Nicotine
NSAIDs
O2
Opioid
Opioids
Oral Contraceptives
Oxycodone
Oxygen
Panic Disorder
Paroxetine
Phenylketonuria
Physical Examination
Placebo
Privacy
Protocol
Psychotropic Drug
Psychotropic Drugs
Quetiapine
Rebreathing
Renal Impairment
Reproducibility
Respiration
Respiratory Depression
Sedative
Serum
Sleep Apnea
Sleep Disorders
Snuff
Syndrome
Tea
Tolerability
Virus
Vital Sign
Washout
Xanthine

Semantics

Type Source Name
drug DRUGBANK Oxygen
drug DRUGBANK Carbon dioxide
drug DRUGBANK Medical air
drug DRUGBANK Benzodiazepine
disease MESH privacy
drug DRUGBANK Ethanol
disease MESH allergies
drug DRUGBANK Acetylsalicylic acid
drug DRUGBANK Acetaminophen
drug DRUGBANK Nicotine
drug DRUGBANK Xanthine
drug DRUGBANK Caffeine
disease MESH disorders Panic
disease MESH Anxiety Disorder
disease MESH Mental Disorders
disease MESH diagnosis
disease MESH cancer
disease MESH renal
disease MESH phenylketonuria
drug DRUGBANK Hepatitis B Vaccine (Recombinant)
disease MESH hypoventilation
disease MESH syndrome
disease MESH sleep apnea
disease MESH Respiratory Insufficiency

Original Article

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