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 | Completed Phase 1

• 1 other identifier: B4981002
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

abuse potential; abuse liability; drug liking; oxycodone; naltrexone; intravenous; pharmacodynamic

Outcome Measures

Primary Outcomes (4)

• Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours

  Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of

  5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

• Drug Liking: Peak Effect (Emax)

  5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

• High: Area Under Effect Curve (AUE) From 0-2 Hours

  High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

• High: Peak Effect (Emax)

  pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

Secondary Outcomes (95)

• Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour

  5 min, 15 min, 30 min, 45 min, 1 h post-dose

• Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours

  5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

• High: Area Under Effect Curve (AUE) From 0-1 Hour

  pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

• High: Area Under Effect Curve (AUE) From 0-8 Hours

  pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

• Take Drug Again: Peak Effect (Emax)

  12, 24 h post-dose

Study Arms (3)

Treatment A

PLACEBO COMPARATOR

Drug: Placebo

Treatment B

EXPERIMENTAL

Drug: Oxycodone + Naltrexone

Treatment C

ACTIVE COMPARATOR

Drug: Oxycodone

Interventions

Placebo DRUG

0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.

Treatment A

Oxycodone + Naltrexone DRUG

Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.

Treatment B

Oxycodone DRUG

Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.

Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Lifetree Clinical Research Center, Salt Lake City, Utah: collaborator

Study Sites (1)

Pfizer Investigational Site

Salt Lake City, Utah, 84106, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Oxycodone; Naltrexone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 5, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

US (1)