Women who are pregnant, lactating or breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of any study session
Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g. cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes)
Participation in any ongoing investigational drug trial/study or clinical drug trial/study
History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
Active positive Hepatitis B, C and HIV serologies
Positive urine drug screening test
Use of any prescription medication during the session 0 to 30 days or over-the counter medication e.g. antihistamines or topical corticosteroids (vitamin, herbal supplements and birth control medications not included) during the session 0 to 3 days before entry to the study
Use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product or agents deemed to be immunosuppressive as determined by physician investigator with 72 hours prior to dosing (e.g. antihistamines, systemic or topical corticosteroids (within 3 weeks prior to dosing), cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy)
Use of monoamine oxidase inhibitors 21 days prior to study
Current use of mixed agonist/antagonist (such as pentazocine, nalbuphine or butorphanol) and partial agonist (buprenorphine) analgesics
Current use of anticholinergics or other medications with anticholinergic activity
Consumption of beverages containing alcohol, grapefruit juice, Seville oranges, or quinine (e.g. tonic water) or foods containing poppy seeds in the last 72 hours.
Donation or loss of greater than one pint of blood within 60 days of entry to the study
Any prior serious adverse reaction or hypersensitivity to fentanyl, morphine, codeine, hydrocodone, hydromorphone, oxycodone, oxymorphone, naltrexone or naloxone or any of the inactive ingredients in the TDDS (polyester/ethyl vinyl acetate, polyacrylate adhesive, silicone adhesive, dimethicone NF, or polyolefin)
Have a diagnosis of schizophrenia or other major psychiatric diagnosis or mental illness (e.g. major depression)
Medical history of personal drug or alcohol addiction or abuse
Any condition that would, in the opinion of the MAI, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
Inability to communicate or cooperate with the investigators
Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application site (upper arm), sunburn, raised moles and scars, open sore, scar tissue, tattoo, or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug
Failure to pass opioid dependence challenge test on the first day study day of any study session (i.e., before taking the first dose of naltrexone hydrochloride). Each subject will be injected subcutaneously with naloxone hydrochloride (0.8 mg injection) and will be observed for 45 minutes for signs and symptoms of opioid withdrawal.
Within 4 weeks prior to dosing, use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product or agents deemed to be immunosuppressive as determined by physician investigator

NCT02531971_exc_T2
Person
Smokers
NCT02531971_exc_T4
Condition
chronic obstructive pulmonary disease
NCT02531971_exc_T5
Condition
cor pulmonale,
NCT02531971_exc_T6
Condition
decreased respiratory reserve
NCT02531971_exc_T7
Condition
hypoxia
NCT02531971_exc_T8
Condition
hypercapnia
NCT02531971_exc_T9
Condition
respiratory depression
NCT02531971_exc_T10
Measurement
HIV serologies
NCT02531971_exc_T11
Measurement
titis B, C logies
Pos
NCT02531971_exc_T12
Measurement
titis B, d logies
Pos
NCT02531971_exc_T13
Scope
Hepatitis B, C and HIV serologies
NCT02531971_exc_T14
Value
positive
NCT02531971_exc_T15
Measurement
urine drug screening test
NCT02531971_exc_T16
Value
Positive
NCT02531971_exc_T19
Drug
monoamine oxidase inhibitors
NCT02531971_exc_T20
Temporal
21 days prior to study
NCT02531971_exc_T21
Reference_point
study
NCT02531971_exc_T22
Drug
pentazocine
NCT02531971_exc_T23
Drug
nalbuphine
NCT02531971_exc_T24
Drug
butorphanol
NCT02531971_exc_T25
Drug
buprenorphine
NCT02531971_exc_T26
Drug
anticholinergics
NCT02531971_exc_T29
Condition
hypersensitivity
NCT02531971_exc_T30
Drug
fentanyl
NCT02531971_exc_T31
Drug
morphine
NCT02531971_exc_T32
Drug
codeine
NCT02531971_exc_T33
Drug
hydrocodone
NCT02531971_exc_T34
Drug
hydromorphone
NCT02531971_exc_T35
Drug
oxycodone
NCT02531971_exc_T36
Drug
oxymorphone
NCT02531971_exc_T37
Drug
naltrexone
NCT02531971_exc_T38
Drug
naloxone
NCT02531971_exc_T39
Device
TDDS
NCT02531971_exc_T40
Device
polyester/ethyl vinyl acetate
NCT02531971_exc_T41
Device
polyacrylate adhesive
NCT02531971_exc_T42
Device
silicone adhesive
NCT02531971_exc_T43
Device
dimethicone NF
NCT02531971_exc_T44
Device
polyolefin
NCT02531971_exc_T45
Scope
fentanyl, morphine, codeine, hydrocodone, hydromorphone, oxycodone, oxymorphone, naltrexone or naloxone or any of the inactive ingredients in the TDDS (polyester/ethyl vinyl acetate, polyacrylate adhesive, silicone adhesive, dimethicone NF, or polyolefin
NCT02531971_exc_T46
Scope
polyester/ethyl vinyl acetate, polyacrylate adhesive, silicone adhesive, dimethicone NF, or polyolefin
NCT02531971_exc_T47
Condition
schizophrenia
NCT02531971_exc_T48
Condition
major psychiatric diagnosis
NCT02531971_exc_T49
Condition
mental illness
NCT02531971_exc_T50
Condition
major depression
NCT02531971_exc_T51
Condition
addiction
NCT02531971_exc_T52
Condition
abuse
NCT02531971_exc_T53
Qualifier
alcohol
NCT02531971_exc_T54
Qualifier
drug
NCT02531971_exc_T55
Scope
drug or alcohol
NCT02531971_exc_T56
Scope
addiction or abuse