A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01825447
- Lead Sponsor
- Pfizer
- Brief Summary
The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- Healthy subjects
- Non-dependent, recreational opioid users
- Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).
- Diagnosis of substance and/or alcohol dependence
- Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
- History of sleep apnea.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A Placebo - Treatment B Oxycodone + Naltrexone - Treatment C Oxycodone -
- Primary Outcome Measures
Name Time Method High: Area Under Effect Curve (AUE) From 0-2 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
High: Peak Effect (Emax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h 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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
Drug Liking: Peak Effect (Emax) 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
- Secondary Outcome Measures
Name Time Method Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Take Drug Again: Mean Effect (Emean) 12, 24 h post-dose Overall Drug Liking: Peak Effect (Emax) 12, 24 h post-dose Overall Drug Liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 to 100 (0 =
Overall Drug Liking: Mean Effect (Emean) 12, 24 h post-dose Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour 5 min, 15 min, 30 min, 45 min, 1 h post-dose Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Nausea: Area Under Effect Curve (AUE) From 0-2 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose Nausea: Area Under Effect Curve (AUE) From 0-8 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour 5 min, 15 min, 30 min, 45 min, 1 h 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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose High: Area Under Effect Curve (AUE) From 0-1 Hour pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
High: Area Under Effect Curve (AUE) From 0-8 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Nausea: Time to Maximum (Peak) Effect (TEmax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Feel Sick: Time to Maximum (Peak) Effect (TEmax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min) pre-dose, 5 min post-dose Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min) pre-dose, 5 min post-dose Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min) pre-dose, 5 min post-dose Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min) pre-dose, 5 min post-dose Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min) pre-dose, 5 min post-dose Plasma Decay Half-Life (t1/2) of Oxycodone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Plasma Decay Half-Life (t1/2) of Oxymorphone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Plasma Decay Half-Life (t1/2) of Noroxycodone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Take Drug Again: Peak Effect (Emax) 12, 24 h post-dose 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-point bipolar VAS with score ranging from 0 mm to 100 (score of 0 =
Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour 5 min, 15 min, 30 min, 45 min, 1 h post-dose Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Any Drug Effects: Peak Effect (Emax) 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Good Drug Effects: Peak Effect (Emax) 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Bad Drug Effects: Peak Effect (Emax) 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Feel Sick: Peak Effect (Emax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Nausea: Peak Effect (Emax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Sleepy: Peak Effect (Emax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Dizzy: Peak Effect (Emax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Nausea: Area Under Effect Curve (AUE) From 0-1 Hour pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose 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 have the size of their pupil measured (in mm) using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Pupillometry: Peak Effect (Emax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Pupillometry: Time to Maximum (Peak) Effect (TEmax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Drug Liking: Time to Maximum (Peak) Effect (TEmax) 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose High: Time to Maximum (Peak) Effect (TEmax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour 5 min, 15 min, 30 min, 45 min, 1 h post-dose Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Systemic Clearance (Cl) of Oxymorphone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Systemic Clearance (Cl) of Noroxycodone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Volume of Distribution at Steady State (Vss) for Oxymorphone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Sleepy: Time to Maximum (Peak) Effect (TEmax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Dizzy: Time to Maximum (Peak) Effect (TEmax) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Plasma Decay Half-Life (t1/2) of Naltrexone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Oxycodone Concentration-Time Curve (AUC0-1h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose AUC is a measure of the plasma concentration of the drug over time.
Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Naltrexone Concentration-Time Curve (AUC0-1h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Oxycodone Concentration-Time Curve (AUC0-2h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Naltrexone Concentration-Time Curve (AUC0-2h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Oxycodone Concentration-Time Curve (AUC0-8h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Naltrexone Concentration-Time Curve (AUC0-8h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast) pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexol pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Systemic Clearance (Cl) of Oxycodone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Systemic Clearance (Cl) of Naltrexone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Systemic Clearance (Cl) of 6-beta-naltrexol pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Volume of Distribution at Steady State (Vss) for 6-beta-naltrexol pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Volume of Distribution at Steady State (Vss) for Oxycodone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Volume of Distribution at Steady State (Vss) for Noroxycodone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose Volume of Distribution at Steady State (Vss) for Naltrexone pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Salt Lake City, Utah, United States