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.
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Drug Liking: Peak Effect (Emax)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
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.
Arms & Interventions
Treatment A
Intervention: Placebo
Treatment B
Intervention: intact ALO-02 60 mg/7.2 mg
Treatment C
Intervention: crushed ALO-02 60 mg/7.2 mg
Treatment D
Intervention: crushed oxycodone IR 60 mg
Treatment E
Intervention: crushed ALO-02 40 mg/4.8 mg
Treatment F
Intervention: crushed oxycodone IR 40 mg
Outcomes
Primary Outcomes
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
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 VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). Peak Effect (Emax) = Maximum observed score.
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
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from '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 hours.
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour
Time Frame: 0.25, 0.5, 1, 1.5, 2 hours post-dose
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 VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
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
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Secondary Outcomes
- Take Drug Again: Mean Effect (Emean)(12, 24, 36 hours post-dose)
- Take Drug Again: Minimum Effect (Emin)(12, 24, 36 hours post-dose)
- Take Drug Again Effect at Hours 12, 24 and 36(12, 24, 36 hours post-dose)
- Overall Drug Liking: Peak Effect (Emax)(12, 24, 36 hours post-dose)
- Overall Drug Liking: Mean Effect (Emean)(12, 24, 36 hours post-dose)
- Overall Drug Liking: Minimum Effect (Emin)(12, 24, 36 hours post-dose)
- Take Drug Again: Peak Effect (Emax)(12, 24, 36 hours post-dose)
- Any Drug Effects: Peak Effect (Emax)(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Overall Drug Liking Effect at Hours 12, 24 and 36(12, 24, 36 hours post-dose)
- 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(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Good Drug Effects: Peak Effect (Emax)(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- 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(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Bad Drug Effects: Peak Effect (Emax)(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- 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(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- 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(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Nausea: Time to Maximum (Peak) Effect (TEmax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Sleepy: Peak Effect (Emax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)(0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Feel Sick: Peak Effect (Emax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- 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(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Feel Sick: Time to Maximum (Peak) Effect (TEmax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Nausea: Peak Effect (Emax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- 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(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Sleepy: Time to Maximum (Peak) Effect (TEmax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Dizzy: Peak Effect (Emax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- 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(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Dizzy: Time to Maximum (Peak) Effect (TEmax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Pupillometry: Peak Effect (Emax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- 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(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Pupillometry: Time to Maximum (Peak) Effect (TEmax)(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone(pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose)