Phase 1
N=45
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01775189 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Drug Liking: Peak Effect (Emax) — 50.9; 60.5; 51.3; 92.8 mm — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ALO-02 weight-matched placebo (Drug); crushed ALO-02 30 mg/3.6 mg (Drug); oxycodone weight-matched placebo (Drug); crushed oxycodone IR 30 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Liking: Peak Effect (Emax) |
50.9; 60.5; 51.3; 92.8 | 0.0001 sig |
| PRIMARY Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour |
98.518; 105.286; 100.241; 159.580 | 0.2176 |
| PRIMARY High: Peak Effect (Emax) |
2.2; 26.6; 6.0; 85.8 | <0.0001 sig |
| PRIMARY High: Area Under Effect Curve (AUE) From 0-2 Hour |
0.871; 27.750; 4.768; 135.670 | 0.0015 sig |
| SECONDARY Take Drug Again: Peak Effect (Emax) |
48.0; 58.3; 46.6; 87.8 | — |
| SECONDARY Take Drug Again: Mean Effect (Emean) |
44.71; 52.16; 43.95; 85.34 | — |
| SECONDARY Take Drug Again Effect at Hours 12 and 24 |
43.4; 51.5; 43.2; 87.4; 46.1; 52.8 | — |
| SECONDARY Overall Drug Liking: Peak Effect (Emax) |
50.5; 59.9; 51.5; 85.1 | — |
| SECONDARY Overall Drug Liking: Mean Effect (Emean) |
50.32; 56.77; 49.16; 81.25 | — |
| SECONDARY Overall Drug Liking Effect at Hours 12 and 24 |
50.3; 56.0; 50.5; 81.8; 50.4; 57.6 | — |
| SECONDARY Any Drug Effects: Peak Effect (Emax) |
0.6; 35.5; 6.2; 88.6 | — |
| SECONDARY Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour |
0.295; 18.647; 1.692; 69.692; 0.429; 38.290 | — |
| SECONDARY Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) |
0.267; 0.517; 0.250; 0.267 | — |
| SECONDARY Good Drug Effects: Peak Effect (Emax) |
4.3; 25.6; 8.4; 87.9 | — |
| SECONDARY Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour |
0.804; 14.263; 2.393; 69.464; 0.902; 26.603 | — |
| SECONDARY Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) |
0.267; 0.275; 0.250; 0.400 | — |
| SECONDARY Bad Drug Effects: Peak Effect (Emax) |
1.4; 13.0; 5.6; 18.5 | — |
| SECONDARY Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour |
0.045; 3.911; 0.246; 4.080; 0.116; 6.920 | — |
| SECONDARY Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) |
0.267; 0.267; 0.250; 0.642 | — |
| SECONDARY Feel Sick: Peak Effect (Emax) |
2.1; 8.7; 3.9; 4.6 | — |
| SECONDARY Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour |
0.036; 1.549; 0.232; 0.442; 0.545; 3.424 | — |
| SECONDARY Feel Sick: Time to Maximum (Peak) Effect (TEmax) |
0.267; 0.267; 0.250; 0.267 | — |
| SECONDARY Nausea: Peak Effect (Emax) |
1.9; 9.3; 5.3; 12.3 | — |
| SECONDARY Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour |
0.036; 2.455; 0.290; 2.339; 0.473; 5.179 | — |
| SECONDARY Nausea: Time to Maximum (Peak) Effect (TEmax) |
0.267; 0.267; 0.250; 0.267 | — |
| SECONDARY Sleepy: Peak Effect (Emax) |
7.6; 35.0; 11.1; 62.9 | — |
| SECONDARY Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour |
0.813; 8.848; 2.920; 20.464; 2.580; 34.571 | — |
| SECONDARY Sleepy: Time to Maximum (Peak) Effect (TEmax) |
0.267; 1.517; 0.267; 2.517 | — |
| SECONDARY Dizzy: Peak Effect (Emax) |
4.4; 7.4; 4.1; 23.5 | — |
| SECONDARY Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour |
0.036; 1.161; 0.795; 9.192; 0.482; 5.134 | — |
| SECONDARY Dizzy: Time to Maximum (Peak) Effect (TEmax) |
0.267; 0.267; 0.250; 0.267 | — |
| SECONDARY Percentage of Dose (Drug Powder) Insufflated |
100.00; 99.85; 100.00; 99.37 | — |
| SECONDARY Pupillometry: Peak Effect (Emax) |
-0.9; -1.7; -0.7; -2.9 | — |
| SECONDARY Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour |
5.333; 4.746; 5.132; 3.229; 10.538; 9.114 | — |
| SECONDARY Pupillometry: Time to Maximum (Peak) Effect (TEmax) |
3.017; 3.017; 2.025; 0.800 | — |
Summary
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
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 and at least once in the 8 weeks before Visit 1 (Screening Visit).
- Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01775189). 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.