A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Oxycodone; Drug: Oxycodone + Naltrexone

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01825447

B4981002

Details and patient eligibility

About

The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.

Enrollment: 89 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects
• Non-dependent, recreational opioid users
• Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Exclusion criteria

• Diagnosis of substance and/or alcohol dependence
• Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
• History of sleep apnea.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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89 participants in 3 patient groups, including a placebo group

Treatment A

Placebo Comparator group

Treatment:

Drug: Placebo

Treatment B

Experimental group

Treatment:

Drug: Oxycodone + Naltrexone

Treatment C

Active Comparator group

Treatment:

Drug: Oxycodone