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To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4mg Intranasal Naltrexone | Experimental | Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril |
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| 4mg Intranasal Naltrexone with Intravail | Experimental | Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril |
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| 2mg Intramuscular Naltrexone | Experimental | Administer 2 mg formulation intramuscularly |
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| 50mg Naltrexone | Experimental | Administer 50mg formulation orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration (Cmax) | 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 | 48 hours |
| Plasma Concentration (Tmax) | 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 | 48 hours |
| Plasma Concentration (AUC 0-t) | 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 | 48 hours |
| Plasma Concentration (AUC 0-inf) | 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 | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Will be reported from the start of the first session to follow-up visit | Maximum of 18 days |
| Vital Signs | Measured before and after naltrexone administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nora Chiang, PhD | National Institute on Drug Abuse (NIDA) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince and Associates Clinical Research, Inc. | Overland Park | Kansas | 66212 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Intravail | Other |
|
| 12 days |
| 12-lead electrocardiogram | Measured before and after naltrexone administration | 12 days |
| Nasal Irritation Scoring | Will be reported from the start of the first session to follow-up visit | 5 days |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |