50316
document
Effects of alcohol on the pharmacokinetics of morphine sulfate and naltrexone hydrochloride extended release capsules . Although contraindicated , coingestion of alcohol and opioids by patients or drug abusers is a major health concern because of dangerous additive and potentially life-threatening sedative and respiratory effects . In addition , alcohol has been shown to disrupt the extended-release characteristics of certain extended-release opioid formulations , releasing a hazardous amount of opioid over a short time period . Morphine sulfate and naltrexone hydrochloride extended release capsules ( MS-sNT ) , which contain naltrexone sequestered in each pellet core , are indicated for management of chronic , moderate to severe pain . Sequestered naltrexone is designed for release upon product tampering ( crushing ) to potentially mitigate morphine-induced subjective effects . This open-label , single-dose , 4-way crossover , pharmacokinetic drug interaction study compared the relative bioavailability of morphine and naltrexone when MS-sNT is administered ( under fasting conditions ) with increasing doses of alcohol . Thirty-two healthy , opioid-naive adults were randomized to MS-sNT administered with 240 mL of 4 % , 20 % , or 40 % alcohol or water . No drug interaction was found between morphine in MS-sNT and 4 % or 20 % alcohol . Administration with 40 % alcohol did not affect overall morphine exposure but was associated with a 2-fold increase in C ( max ) and reduction of t ( max ) from 9 to 4 hours versus MS-sNT taken with water . Naltrexone sequestering was successful in all treatment arms and not affected by coadministration with alcohol over the dose range tested .
50317
Intervention_Pharmacological
alcohol
50318
Intervention_Pharmacological
morphine sulfate
50319
Intervention_Pharmacological
naltrexone hydrochloride
50320
Intervention_Pharmacological
opioids
50321
Intervention_Pharmacological
Morphine sulfate and naltrexone hydrochloride extended release capsules ( MS-sNT )
50322
Intervention_Pharmacological
MS-sNT
50323
Intervention_Pharmacological
alcohol
50324
Intervention_Pharmacological
Naltrexone
50325
Outcome_Other
pharmacokinetics
50326
Outcome_Other
relative bioavailability
50327
Outcome_Physical
of morphine and naltrexone
50328
Outcome_Physical
doses of alcohol
50329
Outcome_Physical
drug interaction
50330
Outcome_Other
overall morphine exposure
50331
Outcome_Other
C ( max )
50332
Outcome_Other
t ( max )
50333
Outcome_Other
Naltrexone sequestering was successful
50334
Participant_Condition
Thirty-two healthy , opioid-naive adults