Status:
COMPLETED
Evaluation of Intranasal Naltrexone and Naloxone
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Contact site for more information
Key Trial Info
Start Date :
October 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03851731
Start Date
October 5 2015
End Date
November 7 2015
Last Update
September 14 2020
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