Evaluation of Intranasal Naltrexone and Naloxone

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Opioid-use Disorder

Treatments: Drug: Naltrexol; Drug: Naloxone; Drug: Naltrexone

Study type: Interventional

Funder types: NIH

Identifiers

NCT03851731

Naltrexone-Ph1a-001

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 3 patient groups

Naltrexone

Experimental group

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

Treatment:

Drug: Naltrexone

Naloxone

Experimental group

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

Treatment:

Drug: Naloxone

Naltrexol

Experimental group

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

Treatment:

Drug: Naltrexol