Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users

A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study to Determine the Abuse Potential of Oral Administration of Crushed EMBEDA Relative to Crushed Controlled-Release Morphine Sulfate and Placebo in Non Dependent, Recreational Opioid Users

The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.

Study Overview

• Status: Completed
• Conditions: Nondependent Opioid Abuse, Episodic
• Intervention / Treatment: Drug: Placebo; Drug: MS Contin (morphine sulfate, controlled release); Drug: EMBEDA (morphine sulfate / naltrexone hydrochloride)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Lifetree Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is a recreational opioid user who is NOT physically dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, and the Naloxone Challenge. A recreational opioid user is defined as recreationally abusing opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to Visit 1.
• Subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

• Has a history or current diagnosis of substance dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
• Has participated in, is currently participating in, or is seeking treatment for substance- and/or alcohol-related disorders (excluding nicotine and caffeine).
• History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
• Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (HCl) or similar compounds and/or the known excipients in the investigational drug products.
• Has any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus).
• Females who are pregnant, lactating, or are planning to become pregnant during the course of the study. Females with a positive serum pregnancy test at Visit 1 or at any subsequent study visit will be excluded from participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage
Active Comparator: MS Contin (morphine sulfate, controlled release)	Drug: MS Contin (morphine sulfate, controlled release); Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
Experimental: EMBEDA (morphine sulfate / naltrexone hydrochloride)	Drug: EMBEDA (morphine sulfate / naltrexone hydrochloride); Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2).	0.5, 1, 1.5 and 2 hrs post-dose
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 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax = Maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
High: Area Under Effect Curve (AUE) From 0-2 Hours	High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	0.5, 1, 1.5 and 2 hrs post-dose
High: Peak Effect (Emax)	High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	0.5 and 1 hrs post-dose
Drug Liking: Area Under Effect Curve (AUE) From 0-4 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 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
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 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Drug Liking: Area Under Effect Curve (AUE) From 0-12 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 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
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 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
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 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). TEmax = Time to maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
High: Area Under Effect Curve (AUE) From 0-1 Hour	High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	0.5 and 1 hrs post-dose
High: Area Under Effect Curve (AUE) From 0-4 Hours	High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
High: Area Under Effect Curve (AUE) From 0-8 Hours	High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
High: Area Under Effect Curve (AUE) From 0-12 Hours	High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
High: Area Under Effect Curve (AUE) From 0-24 Hours	High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
High: Time to Maximum (Peak) Effect (TEmax)	High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour	Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	0.5 and 1 hrs post-dose
Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours	Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	0.5, 1, 1.5 and 2 hrs post-dose
Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours	Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours	Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours	Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours	Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Good Effects: Peak Effect (Emax)	Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Good Effects: Time to Maximum (Peak) Effect (TEmax)	Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour	Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	0.5 and 1 hrs post-dose
Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours	Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	0.5, 1, 1.5 and 2 hrs post-dose
Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours	Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours	Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours	Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours	Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Any Effects: Peak Effect (Emax)	Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Any Effects: Time to Maximum (Peak) Effect (TEmax)	Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour	Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	0.5 and 1 hrs post-dose
Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours	Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	0.5, 1, 1.5 and 2 hrs post-dose
Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours	Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours	Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours	Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours	Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Bad Effects: Peak Effect (Emax)	Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Bad Effects: Time to Maximum (Peak) Effect (TEmax)	Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour	Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	Pre-dose, 0.5 and 1 hrs post-dose
Nausea: Area Under Effect Curve (AUE) From 0-2 Hours	Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Nausea: Area Under Effect Curve (AUE) From 0-4 Hours	Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Nausea: Area Under Effect Curve (AUE) From 0-8 Hours	Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Nausea: Area Under Effect Curve (AUE) From 0-12 Hours	Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Nausea: Area Under Effect Curve (AUE) From 0-24 Hours	Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Nausea: Peak Effect (Emax)	Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Nausea: Time to Maximum (Peak) Effect (TEmax)	Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour	Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	0.5 and 1 hrs post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours	Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	0.5, 1, 1.5 and 2 hrs post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours	Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours	Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours	Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours	Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Feel Sick: Peak Effect (Emax)	Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Feel Sick: Time to Maximum (Peak) Effect (TEmax)	Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour	Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).	0.5 and 1 hrs post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours	Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	0.5, 1, 1.5 and 2 hrs post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours	Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours	Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours	Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours	Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Sleepy: Peak Effect (Emax)	Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Sleepy: Time to Maximum (Peak) Effect (TEmax)	Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour	Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	0.5 and 1 hrs post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours	Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	0.5, 1, 1.5 and 2 hrs post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours	Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours	Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours	Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours	Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Dizzy: Peak Effect (Emax)	Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Dizzy: Time to Maximum (Peak) Effect (TEmax)	Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Overall Drug Liking Effect at 24 Hours	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 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking").	24 hrs post dose
Take Drug Again Effect at 24 Hours	Take drug again 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 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").	24 hrs post dose
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour	Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).	Pre-dose, 0.5 and 1 hrs post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours	Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).	Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours	Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).	Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours	Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours	Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours	Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Pupillometry: Peak Effect (Emax)	Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Pupillometry: Time to Maximum (Peak) Effect (TEmax)	Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine		Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Maximum Observed Plasma Concentration (Cmax) of Morphine		Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine	AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).	Pre-dose, 0.5 and 1 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine	AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).	Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine	AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).	Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine	AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine	AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine	AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine	AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone		Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Maximum Observed Plasma Concentration (Cmax) of Naltrexone		Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone	AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).	Pre-dose, 0.5 and 1 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone	AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).	Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone	AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).	Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone	AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone	AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone	AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone	AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)		Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)		Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)	AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).	Pre-dose, 0.5 and 1 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)	AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).	Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)	AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).	Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)	AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)	AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)	AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)	AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Setnik B, Sommerville K, Goli V, Han L, Webster L. Assessment of pharmacodynamic effects following oral administration of crushed morphine sulfate and naltrexone hydrochloride extended-release capsules compared with crushed morphine sulfate controlled-release tablets and placebo in nondependent recreational opioid users. Pain Med. 2013 Aug;14(8):1173-86. doi: 10.1111/pme.12148. Epub 2013 Jun 7.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): May 31, 2012
• Last Update Submitted That Met QC Criteria: April 26, 2012
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: abuse liability; morphine; abuse potential; recreational opioid use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Wounds and Injuries; Narcotic-Related Disorders; Opioid-Related Disorders; Crush Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Alcohol Deterrents; Naltrexone; Morphine
• Other Study ID Numbers: ALO-01-10-4005; B4541003