Back to resultsEvaluation of Intranasal Naltrexone and Naloxone
Primary Purpose
Opioid-use Disorder
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Naltrexone
Naloxone
Naltrexol
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Contact site for more information
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Naltrexone
Naloxone
Naltrexol
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
Pharmacokinetic parameter [maximum serum concentration - Cmax]
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]
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.
Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
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.
Secondary Outcome Measures
Adverse Events
To assess and document any adverse events measures
Vital Sign - Heart Rate
To assess and document heart rate before and after intranasal dosing
Vital Sign - Blood pressure (diastolic)
To assess and document blood pressure (diastolic) before and after intranasal dosing
Vital Sign - Blood pressure (systolic)
To assess and document blood pressure (systolic) before and after intranasal dosing
Vital Sign - Respiration Rate
To assess and document respiration rate before and after intranasal dosing
Electrocardiogram
Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval.
Full Information
NCT ID
NCT03851731
First Posted
February 19, 2019
Last Updated
September 11, 2020
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03851731
Brief Title
Evaluation of Intranasal Naltrexone and Naloxone
Official Title
Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
November 7, 2015 (Actual)
Study Completion Date
November 7, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naltrexone
Arm Type
Experimental
Arm Description
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
Arm Title
Naloxone
Arm Type
Experimental
Arm Description
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
Arm Title
Naltrexol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Vivitrol
Intervention Description
Intranasal spray
Intervention Type
Drug
Intervention Name(s)
Naloxone
Other Intervention Name(s)
Narcan
Intervention Description
Intranasal spray
Intervention Type
Drug
Intervention Name(s)
Naltrexol
Intervention Description
Intranasal spray
Primary Outcome Measure Information:
Title
Pharmacokinetic parameter [maximum serum concentration - Cmax]
Description
The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration [Cmax], of naltrexone and naloxone when administered and in combination.
Time Frame
12 days
Title
Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]
Description
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.
Time Frame
12 days
Title
Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
Description
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.
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Adverse Events
Description
To assess and document any adverse events measures
Time Frame
15 days
Title
Vital Sign - Heart Rate
Description
To assess and document heart rate before and after intranasal dosing
Time Frame
12 days
Title
Vital Sign - Blood pressure (diastolic)
Description
To assess and document blood pressure (diastolic) before and after intranasal dosing
Time Frame
12 days
Title
Vital Sign - Blood pressure (systolic)
Description
To assess and document blood pressure (systolic) before and after intranasal dosing
Time Frame
12 days
Title
Vital Sign - Respiration Rate
Description
To assess and document respiration rate before and after intranasal dosing
Time Frame
12 days
Title
Electrocardiogram
Description
Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval.
Time Frame
12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Contact site for more information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Chiang, PhD
Organizational Affiliation
NIH / NIDA
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Intranasal Naltrexone and Naloxone
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