Phase 1
N=75
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01746901 ↗Enrolled (actual)
75
Serious AEs
0.2%
Results posted
Oct 2018
Primary outcome: Primary: Drug Liking: Peak Effect (Emax) — 51.6; 70.1; 85.5; 59.3 mm — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 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 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Liking: Peak Effect (Emax) |
51.6; 70.1; 85.5; 59.3; 74.4; 89.7 | <0.0001 sig |
| PRIMARY Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour |
100.004; 118.480; 141.305; 100.188; 127.320; 149.484 | <0.0001 sig |
| PRIMARY High: Peak Effect (Emax) |
10.9; 47.3; 77.9; 21.7; 53.4; 84.7 | <0.0001 sig |
| PRIMARY High: Area Under Effect Curve (AUE) From 0-2 Hour |
2.496; 55.250; 112.082; 9.902; 71.254; 117.578 | <0.0001 sig |
| SECONDARY Take Drug Again: Peak Effect (Emax) |
45.7; 57.9; 83.4; 48.1; 72.0; 81.3 | <0.0001 sig |
| SECONDARY Take Drug Again: Mean Effect (Emean) |
42.90; 54.71; 77.80; 42.63; 68.78; 78.02 | <0.0001 sig |
| SECONDARY Take Drug Again: Minimum Effect (Emin) |
41.1; 50.9; 73.2; 37.8; 66.3; 75.2 | <0.0001 sig |
| SECONDARY Take Drug Again Effect at Hours 12, 24 and 36 |
44.0; 54.7; 79.7; 45.8; 68.7; 78.9 | — |
| SECONDARY Overall Drug Liking: Peak Effect (Emax) |
50.8; 64.3; 80.8; 52.9; 74.0; 81.6 | <0.0001 sig |
| SECONDARY Overall Drug Liking: Mean Effect (Emean) |
50.19; 61.26; 75.70; 47.72; 69.94; 77.90 | <0.0001 sig |
| SECONDARY Overall Drug Liking: Minimum Effect (Emin) |
49.6; 58.5; 71.1; 43.6; 65.6; 74.3 | <0.0001 sig |
| SECONDARY Overall Drug Liking Effect at Hours 12, 24 and 36 |
50.6; 61.2; 78.5; 51.8; 69.8; 78.1 | — |
| SECONDARY Any Drug Effects: Peak Effect (Emax) |
8.8; 47.2; 82.4; 27.7; 56.0; 88.7 | <0.0001 sig |
| 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 |
1.105; 20.129; 40.199; 4.539; 26.566; 48.328 | <0.0001 sig |
| SECONDARY Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) |
0.258; 1.017; 1.017; 0.758; 1.258; 1.017 | <0.0001 sig |
| SECONDARY Good Drug Effects: Peak Effect (Emax) |
11.6; 48.1; 81.8; 24.2; 54.7; 84.3 | <0.0001 sig |
| 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 |
0.805; 20.727; 40.992; 5.254; 28.234; 44.656 | <0.0001 sig |
| SECONDARY Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) |
0.258; 1.017; 1.017; 0.517; 1.017; 1.017 | 0.0016 sig |
| SECONDARY Bad Drug Effects: Peak Effect (Emax) |
5.8; 16.4; 26.5; 20.6; 16.9; 31.4 | 0.0883 |
| 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 |
0.652; 0.977; 4.359; 0.445; 0.918; 3.621 | 0.0351 sig |
| SECONDARY Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) |
0.250; 0.267; 1.517; 0.308; 0.267; 1.758 | 0.0129 sig |
| SECONDARY Feel Sick: Peak Effect (Emax) |
3.1; 5.4; 8.8; 10.1; 2.6; 11.7 | 0.4555 |
| 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 |
0.539; 0.629; 0.957; 0.035; 0.039; 0.996 | 0.1771 |
| SECONDARY Feel Sick: Time to Maximum (Peak) Effect (TEmax) |
0.250; 0.267; 0.267; 0.267; 0.267; 0.267 | 0.1728 |
| SECONDARY Nausea: Peak Effect (Emax) |
6.1; 11.5; 17.8; 9.5; 11.3; 22.0 | 0.0217 sig |
| 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 |
1.551; 1.313; 3.867; 0.043; 0.281; 2.797 | 0.1828 |
| SECONDARY Nausea: Time to Maximum (Peak) Effect (TEmax) |
0.250; 0.267; 0.267; 0.267; 0.267; 0.267 | 0.0041 sig |
| SECONDARY Sleepy: Peak Effect (Emax) |
24.7; 56.8; 72.0; 38.3; 59.2; 76.1 | <0.0001 sig |
| 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 |
3.660; 9.160; 17.555; 9.004; 10.789; 22.590 | <0.0001 sig |
| SECONDARY Sleepy: Time to Maximum (Peak) Effect (TEmax) |
0.758; 2.025; 2.508; 2.000; 2.017; 2.033 | 0.0327 sig |
| SECONDARY Dizzy: Peak Effect (Emax) |
3.6; 23.4; 30.6; 12.0; 19.5; 39.3 | <0.0001 sig |
| 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 |
0.125; 7.117; 10.117; 1.238; 6.207; 14.043 | <0.0001 sig |
| SECONDARY Dizzy: Time to Maximum (Peak) Effect (TEmax) |
0.250; 0.758; 0.767; 0.258; 0.292; 0.758 | 0.5494 |
| SECONDARY Pupillometry: Peak Effect (Emax) |
-0.8; -2.0; -2.7; -2.4; -2.1; -3.0 | <0.0001 sig |
| 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 |
5.160; 4.022; 3.599; 5.039; 3.986; 3.489 | <0.0001 sig |
| SECONDARY Pupillometry: Time to Maximum (Peak) Effect (TEmax) |
2.275; 1.517; 1.517; 12.050; 1.775; 1.533 | <0.0001 sig |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone |
1.03; 1.03; 12.1; 0.583; 1.04; 0.559 | — |
Summary
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.
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.
Data sourced from ClinicalTrials.gov (NCT01746901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.