Evaluation of Intranasal Naltrexone and Naloxone

September 11, 2020 updated by: National Institute on Drug Abuse (NIDA)

Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers

This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Intranasal spray
Other Names:
  • Vivitrol
EXPERIMENTAL: 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
Intranasal spray
Other Names:
  • Narcan
EXPERIMENTAL: 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
Intranasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameter [maximum serum concentration - Cmax]
Time Frame: 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.
12 days
Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]
Time Frame: 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.
12 days
Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
Time Frame: 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.
12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 15 days
To assess and document any adverse events measures
15 days
Vital Sign - Heart Rate
Time Frame: 12 days
To assess and document heart rate before and after intranasal dosing
12 days
Vital Sign - Blood pressure (diastolic)
Time Frame: 12 days
To assess and document blood pressure (diastolic) before and after intranasal dosing
12 days
Vital Sign - Blood pressure (systolic)
Time Frame: 12 days
To assess and document blood pressure (systolic) before and after intranasal dosing
12 days
Vital Sign - Respiration Rate
Time Frame: 12 days
To assess and document respiration rate before and after intranasal dosing
12 days
Electrocardiogram
Time Frame: 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.
12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Nora Chiang, PhD, NIH / NIDA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2015

Primary Completion (ACTUAL)

November 7, 2015

Study Completion (ACTUAL)

November 7, 2015

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (ACTUAL)

February 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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