Opioid-Related Disorders
Conditions
Brief summary
To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.
Interventions
DRUGNaltrexone
OTHERIntravail
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females 18 to 55 years of age, inclusive. * Provide written informed consent. * 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. * Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration. Female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 30 days after the last study drug administration. Oral contraceptives are prohibited. * Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice. * Participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
Exclusion criteria
* Please contact site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration (AUC 0-inf) | 48 hours | Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration |
| Plasma Concentration (Cmax) | 48 hours | Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration |
| Plasma Concentration (Tmax) | 48 hours | Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration |
| Plasma Concentration (AUC 0-t) | 48 hours | Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Maximum of 18 days | Will be reported from the start of the first session to follow-up visit |
| Vital Signs | 12 days | Measured before and after naltrexone administration |
| 12-lead electrocardiogram | 12 days | Measured before and after naltrexone administration |
| Nasal Irritation Scoring | 5 days | Will be reported from the start of the first session to follow-up visit |
Countries
United States
Outcome results
None listed