Clinical trial NCT01746901: A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
Official title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Single-dose, 6-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 Orally To Nondependent,Recreational Opioid Users.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Relative abuse potential study; oxycodone; nalteone; Opioid-related disorders; drug abusers
Chronic pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2012-12-11
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

Detailed description: Abuse Liability Study

Eligibility criteria: 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 before Screening Visit, and at least once in 8 weeks before the Screening Visit.

Exclusion Criteria:

* Diagnosis of substance and/or alcohol dependence.
* Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder.
* History of sleep apnea.
* Positive urine drug screen (UDS) for other that marijuana.
* Positive for Hepatitis B or C and HIV on Screening.

Primary outcomes:
measure: Drug Liking: Peak Effect (Emax)
timeFrame: 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
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour
timeFrame: 0.25, 0.5, 1, 1.5, 2 hours post-dose
measure: High: Peak Effect (Emax)
timeFrame: 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
measure: High: Area Under Effect Curve (AUE) From 0-2 Hour
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2 hours post-dose
Secondary outcomes:
measure: Take Drug Again: Peak Effect (Emax)
timeFrame: 12, 24, 36 hours post-dose
measure: Take Drug Again: Mean Effect (Emean)
timeFrame: 12, 24, 36 hours post-dose
measure: Take Drug Again: Minimum Effect (Emin)
timeFrame: 12, 24, 36 hours post-dose
measure: Take Drug Again Effect at Hours 12, 24 and 36
timeFrame: 12, 24, 36 hours post-dose
measure: Overall Drug Liking: Peak Effect (Emax)
timeFrame: 12, 24, 36 hours post-dose
measure: Overall Drug Liking: Mean Effect (Emean)
timeFrame: 12, 24, 36 hours post-dose
measure: Overall Drug Liking: Minimum Effect (Emin)
timeFrame: 12, 24, 36 hours post-dose
measure: Overall Drug Liking Effect at Hours 12, 24 and 36
timeFrame: 12, 24, 36 hours post-dose
measure: Any Drug Effects: Peak Effect (Emax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Good Drug Effects: Peak Effect (Emax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Bad Drug Effects: Peak Effect (Emax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Feel Sick: Peak Effect (Emax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Feel Sick: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Nausea: Peak Effect (Emax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Nausea: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Sleepy: Peak Effect (Emax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Sleepy: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Dizzy: Peak Effect (Emax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Dizzy: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Pupillometry: Peak Effect (Emax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Pupillometry: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
Other outcomes:
measure: Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Drug Liking: Time to Maximum (Peak) Effect (TEmax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: High: Time to Maximum (Peak) Effect (TEmax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Plasma Terminal Half-Life (t1/2) of Oxycodone
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: 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
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)dn] of Oxycodone
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Screening up to 28 days after last study drug administration (Day 29)
measure: Number of Participants With Clinically Significant Change in Vital Sign Examinations
timeFrame: Screening up to 7 days following last study drug administration (Day 8)
measure: Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)
timeFrame: 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
measure: Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)
timeFrame: pre-dose up to 5 hours in drug discrimination phase; pre-dose up to 12 hours in intervention period
Locations:
city: Toronto
country: Canada
facility: INC Research Toronto, Inc.
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: