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

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Single-Dose, 4-Way Crossover Study to Determine the Relative Abuse Potential of ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended Release Capsules) Compared to Oxycodone Immediate Release and Placebo When Administered Intranasally to Non-Dependent, Recreational Opioid Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775189
• Other study ID #: B4531009
• Status: Completed
• Phase: Phase 1
• First received: January 22, 2013
• Last updated: September 11, 2013
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Abuse Liability Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALO-02 weight-matched placebo
crushed sugar spheres (powder) x 1 dose
• crushed ALO-02 30 mg/3.6 mg
crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
• oxycodone weight-matched placebo
crushed lactose tablets (powder) x 1 dose
• crushed oxycodone IR 30 mg
Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	INC Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Primary	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	0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Primary	High: Peak Effect (Emax)	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, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose
Primary	Drug Liking: Peak Effect (Emax)	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	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour	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	0, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Drug Liking: Area Under Effect Curve (AUE) From 0-8 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	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Drug Liking: Area Under Effect Curve (AUE) From 0-24 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	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	High: Area Under Effect Curve (AUE) From 0-1 Hour	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). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	High: Area Under Effect Curve (AUE) From 0-8 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). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	High: Area Under Effect Curve (AUE) From 0-24 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). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Take Drug Again: Peak Effect (Emax)	Take drug again visual analogue scale (VAS) is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100-point VAS with score ranging from 0 to 100 (score of 0 =	12, 24 h post-dose	No
Secondary	Take Drug Again: Mean Effect (Emean)		12, 24 h post-dose	No
Secondary	Overall Drug Liking: Peak Effect (Emax)	Overall Drug Liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 to 100 (0 =	12, 24 h post-dose	No
Secondary	Overall Drug Liking: Mean Effect (Emean)		12, 24 h post-dose	No
Secondary	Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour	Any Drug Effects 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). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours	Any Drug Effects 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). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours	Any Drug Effects 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). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Any Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours	Any Drug Effects 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). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h	No
Secondary	Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour	Good Drug Effects 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). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours	Good Drug Effects 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). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours	Good Drug Effects 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). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Good Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours	Good Drug Effects 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). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour	Bad Drug Effects 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). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours	Bad Drug Effects 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). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours	Bad Drug Effects 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). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Bad Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours	Bad Drug Effects 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). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour	Feel Sick 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). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours	Feel Sick 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). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours	Feel Sick 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). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours	Feel Sick 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). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Nausea: Area Under Effect Curve (AUE) From 0-1 Hour	Nausea 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). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Nausea: Area Under Effect Curve (AUE) From 0-2 Hours	Nausea 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). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Nausea: Area Under Effect Curve (AUE) From 0-8 Hours	Nausea 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). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Nausea: Area Under Effect Curve (AUE) From 0-24 Hours	Nausea 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). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour	Sleepy 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). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours	Sleepy 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). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Sleepy: Area Under Effect Curve (AUE) From 0-8 Hour	Sleepy 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). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Sleepy: Area Under Effect Curve (AUE) From 0-24 Hour	Sleepy 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). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour	Dizzy 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). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours	Dizzy 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). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours	Dizzy 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). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours	Dizzy 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). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Any Drug Effects: Peak Effect (Emax)	Any Drug Effects 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).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Good Drug Effects: Peak Effect (Emax)	Good Drug Effects 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).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Bad Drug Effects: Peak Effect (Emax)	Bad Drug Effects 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).	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Feel Sick: Peak Effect (Emax)	Feel Sick 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, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Nausea: Peak Effect (Emax)	Nausea 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, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Sleepy: Peak Effect (Emax)	Sleepy 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, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Dizzy: Peak Effect (Emax)	Dizzy 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, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour for "burning"	A 6-point scale assessing 5 categories: burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion.	pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	Yes
Secondary	Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-2 Hours for "burning"		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	Yes
Secondary	Subject Rating Scale for Nasal Effects: Peak Effect (Emax) for "burning"		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	Yes
Secondary	Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) for "burning"		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	Yes
Secondary	Percentage of dose (drug powder) insufflated	Weight of drug powder remaining (if any) after dosing.	up to 5 min post-dose	No
Secondary	Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour	Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours	Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours	Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours	Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Pupillometry: Peak Effect (Emax)	Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Pupillometry: Time to Maximum (Peak) Effect (TEmax)	Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Drug Liking: Time to Maximum (Peak) Effect (TEmax)	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	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	High: Time to Maximum (Peak) Effect (TEmax)	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). TEmax = Time to maximum observed score.	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)	Any Drug Effects 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). TEmax = Time to maximum observed score.	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)	Good Drug Effects 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). TEmax = Time to maximum observed score.	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)	Bad Drug Effects 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). TEmax = Time to maximum observed score.	0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Sleepy: Time to Maximum (Peak) Effect (TEmax)	Sleepy 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). TEmax = Time to maximum observed score.	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Dizzy: Time to Maximum (Peak) Effect (TEmax)	Dizzy 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). TEmax = Time to maximum observed score.	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Nausea: Time to Maximum (Peak) Effect (TEmax)	Nausea 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). TEmax = Time to maximum observed score.	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Feel Sick: Time to Maximum (Peak) Effect (TEmax)	Feel Sick 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). TEmax = Time to maximum observed score.	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of Oxycodone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of Oxymorphone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of Noroxycodone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of Naltrexone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of 6-beta-naltrexol		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxymorphone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Noroxycodone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of 6-beta-naltrexol		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Plasma Decay Half-Life (t1/2) of Oxycodone	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Plasma Decay Half-Life (t1/2) of Oxymorphone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Plasma Decay Half-Life (t1/2) of Noroxycodone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Plasma Decay Half-Life (t1/2) of Naltrexone		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Area Under the Oxycodone Concentration-Time Curve (AUC0-1h)	AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.	pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h)		pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h)		pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Area Under the Naltrexone Concentration-Time Curve (AUC0-1h)		pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h)		pre-dose, 0.25, 0.5, 0.75, 1 h post-dose	No
Secondary	Area Under the Oxycodone Concentration-Time Curve (AUC0-2h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Area Under the Naltrexone Concentration-Time Curve (AUC0-2h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose	No
Secondary	Area Under the Oxycodone Concentration-Time Curve (AUC0-8h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Area Under the Naltrexone Concentration-Time Curve (AUC0-8h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast)		pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose	No

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