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

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ClinicalTrials.gov Identifier: NCT01746901
Recruitment Status : Completed
First Posted : December 11, 2012
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition: Healthy
Interventions: Drug: Placebo
Drug: intact ALO-02 60 mg/7.2 mg
Drug: crushed ALO-02 60 mg/7.2 mg
Drug: crushed oxycodone IR 60 mg
Drug: crushed ALO-02 40 mg/4.8 mg
Drug: crushed oxycodone IR 40 mg

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recreational opioid users who were not dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, were recruited in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After successful naloxone challenge test, all participants underwent training sessions involving complete pharmacodynamics test battery before the drug discrimination phase, to ensure that participants fully understood how to perform the tests, were comfortable, and attained a stable level of performance on the various performance-based measures.

Reporting Groups
  Description
Naloxone Naloxone hydrochloride (HCl) 0.2 milligram (mg) intravenously followed by additional 0.6 mg naloxone hydrochloride intravenously on Day 0, each dose followed by an assessment for signs and symptoms of opioid withdrawal. Participants who did not display signs and symptoms of opioid withdrawal, were assigned to either oxycodone HCl 40 mg then placebo or placebo then oxycodone HCl 40 mg group in the drug discrimination phase of the study.
Oxycodone HCl 40 mg Then PBO Single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 1 followed by single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study.
PBO Then Oxycodone HCl 40 mg Single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 1 followed by single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study.
ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in second intervention period; then single dose of matching placebo (PBO) orally on Day 1 in third intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on orally on Day 1 in second intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in third intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of matching placebo (PBO) orally on Day 1 in second intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in third intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fifth intervention period; then by single dose of matching placebo (PBO) orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg Single dose of matching placebo (PBO) orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in second intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 40 mg/4.8 mg crushed capsule (ALO-02 40 mg-I) solution orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.

Participant Flow for 14 periods

Period 1:   Naloxone Challenge Phase
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   75   0   0   0   0   0   0   0   0 
COMPLETED   72   0   0   0   0   0   0   0   0 
NOT COMPLETED   3   0   0   0   0   0   0   0   0 
Adverse Event                2                0                0                0                0                0                0                0                0 
Did not meet entrance criteria                1                0                0                0                0                0                0                0                0 

Period 2:   Drug Discrimination Phase: Day 1
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   36   36   0   0   0   0   0   0 
COMPLETED   0   33   36   0   0   0   0   0   0 
NOT COMPLETED   0   3   0   0   0   0   0   0   0 
Adverse Event                0                3                0                0                0                0                0                0                0 

Period 3:   Drug Discrimination Phase: Day 2
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   33   36   0   0   0   0   0   0 
COMPLETED   0   19   22   0   0   0   0   0   0 
NOT COMPLETED   0   14   14   0   0   0   0   0   0 
Adverse Event                0                2                1                0                0                0                0                0                0 
Did not met entrance criteria                0                9                10                0                0                0                0                0                0 
Protocol Violation                0                3                3                0                0                0                0                0                0 

Period 4:   Treatment Phase: First Intervention
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   6   6   7   8   7   7 
COMPLETED   0   0   0   6   6   7   7   7   7 
NOT COMPLETED   0   0   0   0   0   0   1   0   0 
Protocol Violation                0                0                0                0                0                0                1                0                0 

Period 5:   Treatment Phase: Washout Period 1
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   6   6   7   7   7   7 
COMPLETED   0   0   0   6   6   7   7   7   7 
NOT COMPLETED   0   0   0   0   0   0   0   0   0 

Period 6:   Treatment Phase: Second Intervention
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   6   6   7   7   7   7 
COMPLETED   0   0   0   6   6   7   7   6   7 
NOT COMPLETED   0   0   0   0   0   0   0   1   0 
Withdrawal by Subject                0                0                0                0                0                0                0                1                0 

Period 7:   Treatment Phase: Washout Period 2
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   6   6   7   7   6   7 
COMPLETED   0   0   0   6   6   7   7   6   7 
NOT COMPLETED   0   0   0   0   0   0   0   0   0 

Period 8:   Treatment Phase: Third Intervention
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   6   6   7   7   6   7 
COMPLETED   0   0   0   6   6   6   6   6   7 
NOT COMPLETED   0   0   0   0   0   1   1   0   0 
Protocol Violation                0                0                0                0                0                1                1                0                0 

Period 9:   Treatment Phase: Washout Period 3
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   6   6   6   6   6   7 
COMPLETED   0   0   0   6   6   6   6   6   7 
NOT COMPLETED   0   0   0   0   0   0   0   0   0 

Period 10:   Treatment Phase: Fourth Intervention
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   6   6   6   6   6   7 
COMPLETED   0   0   0   5   6   5   5   6   5 
NOT COMPLETED   0   0   0   1   0   1   1   0   2 
Lost to Follow-up                0                0                0                1                0                0                0                0                0 
Adverse Event                0                0                0                0                0                1                0                0                1 
Protocol Violation                0                0                0                0                0                0                1                0                1 

Period 11:   Treatment Phase: Washout Period 4
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   5   6   5   5   6   5 
COMPLETED   0   0   0   5   6   5   5   6   5 
NOT COMPLETED   0   0   0   0   0   0   0   0   0 

Period 12:   Treatment Phase: Fifth Intervention
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   5   6   5   5   6   5 
COMPLETED   0   0   0   5   6   5   5   6   5 
NOT COMPLETED   0   0   0   0   0   0   0   0   0 

Period 13:   Treatment Phase: Washout Period 5
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   5   6   5   5   6   5 
COMPLETED   0   0   0   5   6   5   5   6   5 
NOT COMPLETED   0   0   0   0   0   0   0   0   0 

Period 14:   Treatment Phase: Sixth Intervention
    Naloxone   Oxycodone HCl 40 mg Then PBO   PBO Then Oxycodone HCl 40 mg   ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C   ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I   ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg   OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C   OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO   PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
STARTED   0   0   0   5   6   5   5   6   5 
COMPLETED   0   0   0   5   6   5   5   6   5 
NOT COMPLETED   0   0   0   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set included all participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Entire Study Population Included all participants enrolled in the study.

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 75 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.6  (9.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18  24.0% 
Male      57  76.0% 


  Outcome Measures

1.  Primary:   Drug Liking: Peak Effect (Emax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase ]

2.  Primary:   Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour   [ Time Frame: 0.25, 0.5, 1, 1.5, 2 hours post-dose ]

3.  Primary:   High: Peak Effect (Emax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase ]

4.  Primary:   High: Area Under Effect Curve (AUE) From 0-2 Hour   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2 hours post-dose ]

5.  Secondary:   Take Drug Again: Peak Effect (Emax)   [ Time Frame: 12, 24, 36 hours post-dose ]

6.  Secondary:   Take Drug Again: Mean Effect (Emean)   [ Time Frame: 12, 24, 36 hours post-dose ]

7.  Secondary:   Take Drug Again: Minimum Effect (Emin)   [ Time Frame: 12, 24, 36 hours post-dose ]

8.  Secondary:   Take Drug Again Effect at Hours 12, 24 and 36   [ Time Frame: 12, 24, 36 hours post-dose ]

9.  Secondary:   Overall Drug Liking: Peak Effect (Emax)   [ Time Frame: 12, 24, 36 hours post-dose ]

10.  Secondary:   Overall Drug Liking: Mean Effect (Emean)   [ Time Frame: 12, 24, 36 hours post-dose ]

11.  Secondary:   Overall Drug Liking: Minimum Effect (Emin)   [ Time Frame: 12, 24, 36 hours post-dose ]

12.  Secondary:   Overall Drug Liking Effect at Hours 12, 24 and 36   [ Time Frame: 12, 24, 36 hours post-dose ]

13.  Secondary:   Any Drug Effects: Peak Effect (Emax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

14.  Secondary:   Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

15.  Secondary:   Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

16.  Secondary:   Good Drug Effects: Peak Effect (Emax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

17.  Secondary:   Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

18.  Secondary:   Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

19.  Secondary:   Bad Drug Effects: Peak Effect (Emax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

20.  Secondary:   Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

21.  Secondary:   Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

22.  Secondary:   Feel Sick: Peak Effect (Emax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

23.  Secondary:   Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

24.  Secondary:   Feel Sick: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

25.  Secondary:   Nausea: Peak Effect (Emax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

26.  Secondary:   Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

27.  Secondary:   Nausea: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

28.  Secondary:   Sleepy: Peak Effect (Emax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

29.  Secondary:   Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

30.  Secondary:   Sleepy: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

31.  Secondary:   Dizzy: Peak Effect (Emax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

32.  Secondary:   Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

33.  Secondary:   Dizzy: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

34.  Secondary:   Pupillometry: Peak Effect (Emax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

35.  Secondary:   Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

36.  Secondary:   Pupillometry: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

37.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

38.  Other Pre-specified:   Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

39.  Other Pre-specified:   Drug Liking: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

40.  Other Pre-specified:   High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

41.  Other Pre-specified:   High: Time to Maximum (Peak) Effect (TEmax)   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

42.  Other Pre-specified:   Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

43.  Other Pre-specified:   Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

44.  Other Pre-specified:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

45.  Other Pre-specified:   Plasma Terminal Half-Life (t1/2) of Oxycodone   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

46.  Other Pre-specified:   Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

47.  Other Pre-specified:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

48.  Other Pre-specified:   Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)dn] of Oxycodone   [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose ]

49.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Screening up to 28 days after last study drug administration (Day 29) ]

50.  Other Pre-specified:   Number of Participants With Clinically Significant Change in Vital Sign Examinations   [ Time Frame: Screening up to 7 days following last study drug administration (Day 8) ]

51.  Other Pre-specified:   Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)   [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5 hours post-dose in drug discrimination phase; pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in intervention period ]

52.  Other Pre-specified:   Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)   [ Time Frame: pre-dose up to 5 hours in drug discrimination phase; pre-dose up to 12 hours in intervention period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01746901     History of Changes
Other Study ID Numbers: B4531008
First Submitted: December 7, 2012
First Posted: December 11, 2012
Results First Submitted: September 30, 2016
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018