Evaluation of Intranasal Naltrexone and Naloxone
- Conditions
- Opioid-use Disorder
- Interventions
- Registration Number
- NCT03851731
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- Brief Summary
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Males and females 18 to 55 years of age, inclusive.
- Provide written informed consent.
- Body mass index (BMI) ranging from 18 to 30 kg/m2, inclusive.
- Adequate venous access.
- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
- Agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
- Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca Cola®, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
- Contact site for more information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Naloxone Naloxone Subject received a single intranasal dose of 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered Naltrexol Naltrexol Subject received a single intranasal dose of a combination of 2 mg naltrexone and 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered Naltrexone Naltrexone Subject received a single intranasal dose of 2 mg naltrexone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf] 12 days The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity \[AUCO-inf\] of naltrexone and naloxone when administered and in combination.
Pharmacokinetic parameter [maximum serum concentration - Cmax] 12 days The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration \[Cmax\], of naltrexone and naloxone when administered and in combination.
Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t] 12 days The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve \[AUCO-t\] of naltrexone and naloxone when administered and in combination.
- Secondary Outcome Measures
Name Time Method Adverse Events 15 days To assess and document any adverse events measures
Vital Sign - Blood pressure (systolic) 12 days To assess and document blood pressure (systolic) before and after intranasal dosing
Vital Sign - Heart Rate 12 days To assess and document heart rate before and after intranasal dosing
Vital Sign - Respiration Rate 12 days To assess and document respiration rate before and after intranasal dosing
Vital Sign - Blood pressure (diastolic) 12 days To assess and document blood pressure (diastolic) before and after intranasal dosing
Electrocardiogram 12 days Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval.