A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: intact ALO-02 60 mg/7.2 mg; Drug: crushed ALO-02 40 mg/4.8 mg; Drug: crushed oxycodone IR 60 mg; Drug: Placebo; Drug: crushed oxycodone IR 40 mg; Drug: crushed ALO-02 60 mg/7.2 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01746901

B4531008

Details and patient eligibility

About

The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

Full description

Abuse Liability Study

Enrollment: 81 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects.
• Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit.

Exclusion criteria

• Diagnosis of substance and/or alcohol dependence.
• Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder.
• History of sleep apnea.
• Positive urine drug screen (UDS) for other that marijuana.
• Positive for Hepatitis B or C and HIV on Screening.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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81 participants in 6 patient groups, including a placebo group

Treatment A

Placebo Comparator group

Treatment:

Drug: Placebo

Treatment B

Experimental group

Treatment:

Drug: intact ALO-02 60 mg/7.2 mg

Treatment C

Experimental group

Treatment:

Drug: crushed ALO-02 60 mg/7.2 mg

Treatment D

Active Comparator group

Treatment:

Drug: crushed oxycodone IR 60 mg

Treatment E

Experimental group

Treatment:

Drug: crushed ALO-02 40 mg/4.8 mg

Treatment F

Active Comparator group

Treatment:

Drug: crushed oxycodone IR 40 mg