A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: crushed ALO-02 30 mg/3.6 mg; Drug: oxycodone weight-matched placebo; Drug: ALO-02 weight-matched placebo; Drug: crushed oxycodone IR 30 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01775189

B4531009

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 when they are crushed and snorted.

Full description

Abuse Liability Study

Enrollment: 45 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 and at least once in the 8 weeks before Visit 1 (Screening Visit).
• Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 4 patient groups, including a placebo group

Treatment A

Placebo Comparator group

Treatment:

Drug: ALO-02 weight-matched placebo

Treatment B

Experimental group

Treatment:

Drug: crushed ALO-02 30 mg/3.6 mg

Treatment C

Placebo Comparator group

Treatment:

Drug: oxycodone weight-matched placebo

Treatment D

Active Comparator group

Treatment:

Drug: crushed oxycodone IR 30 mg