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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01746901

Healthy

COMPLETED PHASE1

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

NCT01825447

Healthy

COMPLETED PHASE1

A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

NCT01571362

Chronic Pain Low Back Pain Analgesia

COMPLETED PHASE3

Pharmacokinetics Study of ALO-02 and OxyContin

NCT01557257

Management of Moderate to Severe Pain

COMPLETED PHASE1

Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)

NCT00751478

Healthy

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Abuse Liability Study

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment A

Group Type PLACEBO_COMPARATOR

ALO-02 weight-matched placebo

Intervention Type DRUG

crushed sugar spheres (powder) x 1 dose

Treatment B

Group Type EXPERIMENTAL

crushed ALO-02 30 mg/3.6 mg

Intervention Type DRUG

crushed ALO-02 30 mg/3.6 mg capsule x 1 dose

Treatment C

Group Type PLACEBO_COMPARATOR

oxycodone weight-matched placebo

Intervention Type DRUG

crushed lactose tablets (powder) x 1 dose

Treatment D

Group Type ACTIVE_COMPARATOR

crushed oxycodone IR 30 mg

Intervention Type DRUG

Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALO-02 weight-matched placebo

crushed sugar spheres (powder) x 1 dose

Intervention Type DRUG

crushed ALO-02 30 mg/3.6 mg

crushed ALO-02 30 mg/3.6 mg capsule x 1 dose

Intervention Type DRUG

oxycodone weight-matched placebo

crushed lactose tablets (powder) x 1 dose

Intervention Type DRUG

crushed oxycodone IR 30 mg

Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes