Table 2.
Subjective drug effects (DEQ and VAS), opiate withdrawal symptoms (SOWS), cognitive performance (DSST), divided attention (DAT), and physiological parameters after administration of active oxycodone (10 mg) or placebo oxycodone (0 mg) in the active lorcaserin (10 mg BID) versus the placebo lorcaserin (0 mg BID) condition. Values represent the mean effect after administration of the first (sample) dose of oxycodone or placebo (measured 5, 15, 30, and 45 minutes post-dose) on Day 1.
| Placebo Lorcaserin | Active Lorcaserin | |||||||
|---|---|---|---|---|---|---|---|---|
| Effect | Oxycodone (Mean, SEM) | Placebo (Mean, SEM) | Oxycodone (Mean, SEM) | Placebo (Mean, SEM) | Lorcaserin Dose (p-value) | Oxycodone Dose (p-value) | Lorcaserin x Oxycodone (p-value) | |
| DEQ | ||||||||
| Bad | 0.04 (0.0) | 0.0 (0.0) | 0.0 (0.0) | 0.0 (0.0) | 0.17 | 0.17 | 0.17 | |
| Good | 0.5 (0.1) | 0.1 (0.0) | 0.7 (0.1) | 0.2 (0.1) | 0.27 | 0.01* | 0.72 | |
| Like | −0.2 (0.3) | −1.8 (0.3) | 0.5 (0.3) | −1.8 (0.3) | 0.34 | 0.01* | 0.34 | |
| Strong | 0.6 (0.1) | 0.1 (0.0) | 0.8 (0.1) | 0.3 (0.1) | 0.30 | 0.00* | 0.93 | |
| Take again | 1.1 (0.2) | 0.1 (0.0) | 0.9 (0.1) | 0.1 (0.1) | 0.43 | 0.00* | 0.28 | |
| VAS - Mood | ||||||||
| Alert | 33.4 (4.2) | 31.1 (5.1) | 39.0 (4.7) | 23.3 (4.2) | 0.85 | 0.15 | 0.22 | |
| Anxious | 26.1 (4.5) | 16.9 (3.6) | 34.0 (5.5) | 30.1 (5.0) | 0.09 | 0.16 | 0.65 | |
| Bad Effect | 3.3 (1.8) | 1.0 (0.7) | 0.4 (0.2) | 2.0 (0.1) | 0.10 | 0.19 | 0.26 | |
| Depressed | 19.5 (4.7) | 9.7 (3.4) | 7.6 (2.1) | 8.5 (2.4) | 0.07 | 0.42 | 0.38 | |
| Energetic | 14.2 (3.3) | 9.9 (3.2) | 18.5 (3.2) | 9.8 (3.0) | 0.44 | 0.18 | 0.68 | |
| Good Effect | 6.4 (1.6) | 0.8 (0.2) | 6.4 (1.8) | 0.7 (0.2) | 0.97 | 0.03° | 0.97 | |
| Gooseflesh | 18.3 (4.6) | 6.4 (1.9) | 14.5 (4.1) | 17.8 (4.8) | 0.44 | 0.33 | 0.18 | |
| High | 3.9 (1.1) | 0.7 (0.2) | 5.0 (1.5) | 0.5 (0.3) | 0.70 | 0.07 | 0.59 | |
| High Quality | 9.4 (2.7) | 5.0 (2.1) | 5.5 (1.6) | 2.5 (1.2) | 0.07 | 0.09 | 0.73 | |
| I Would Pay ($) | 1.4 (0.3) | 0.4 (0.2) | 1.7 (0.4) | 1.6 (0.2) | 0.69 | 0.04° | 0.61 | |
| Irritable | 25.4 (4.4) | 24.2 (4.9) | 21.8 (4.7) | 21.3 (4.2) | 0.21 | 0.86 | 0.93 | |
| Like | 8.4 (2.2) | 2.8 (1.3) | 8.2 (2.0) | 2.5 (1.2) | 0.87 | 0.02° | 0.98 | |
| Mellow | 24.6 (3.7) | 17.8 (3.4) | 16.5 (3.2) | 10.9 (2.8) | 0.20 | 0.02° | 0.81 | |
| Muscle Pain | 11.4 (3.6) | 13.1 (3.5) | 17.8 (4.3) | 21.1 (4.2) | 0.17 | 0.76 | 0.87 | |
| Nauseated | 4.6 (1.8) | 1.4 (0.5) | 8.5 (3.5) | 6.8 (2.8) | 0.43 | 0.37 | 0.33 | |
| Potent | 7.0 (2.1) | 2.8 (1.3) | 4.7 (1.6) | 2.7 (1.2) | 0.45 | 0.04° | 0.47 | |
| Restless | 4.9 (1.8) | 1.1 (0.4) | 4.1 (1.2) | 1.3 (0.4) | 0.80 | 0.04° | 0.65 | |
| Sedated | 4.9 (1.8) | 1.1 (0.4) | 3.7 (1.2) | 4.7 (1.8) | 0.07 | 0.10 | 0.18 | |
| Sleepy | 16.3 (4.0) | 18.6 (4.1) | 5.6 (1.9) | 14.4 (3.5) | 0.27 | 0.28 | 0.35 | |
| Social | 20.1 (3.3) | 12.2 (3.1) | 17.0 (2.6) | 12.2 (2.9) | 0.68 | 0.07 | 0.68 | |
| Stimulated | 9.2 (2.7) | 7.8 (3.1) | 5.1 (1.3) | 6.1 (2.6) | 0.43 | 0.96 | 0.61 | |
| Talkative | 20.1 (3.7) | 14.4 (3.6) | 13.5 (2.4) | 9.2 (2.6) | 0.09 | 0.14 | 0.82 | |
| VAS - Craving | ||||||||
| Want Alcohol | 14.9 (3.7) | 11.2 (3.6) | 9.1 (2.6) | 13.8 (3.9) | 0.33 | 0.86 | 0.10 | |
| Want Cocaine | 4.8 (1.7) | 5.2 (1.9) | 4.1 (1.5) | 4.6 (1.4) | 0.79 | 0.67 | 0.99 | |
| Want Heroin | 61.7 (5.2) | 73.7 (4.8) | 78.3 (4.5) | 70.5 (4.8) | 0.37 | 0.70 | 0.05° | |
| Want Tobacco | 53.5 (5.7) | 49.0 (5.9) | 47.5 (5.8) | 48.5 (5.6) | 0.27 | 0.19 | 0.10 | |
| SOWS | ||||||||
| Sum | 10.8 (3.3) | 6.8 (1.9) | 12.7 (4.3) | 9.8 (3.5) | 0.23 | 0.10 | 0.77 | |
| DAT | ||||||||
| # False Alarms | 1.3 (0.4) | 1.2 (0.4) | 1.2 (0.4) | 1.2 (0.4) | 0.92 | 0.92 | 0.92 | |
| # Hits | 19.1 (0.2) | 18.8 (0.2) | 19.2 (0.1) | 18.7 (0.2) | 1.00 | 0.05° | 0.42 | |
| # Misses | 0.4 (0.2) | 0.5 (0.2) | 0.1 (0.0) | 0.6 (0.2) | 0.67 | 0.09 | 0.29 | |
| Maximum Speed | 4.8 (0.5) | 4.2 (0.6) | 4.4 (0.4) | 4.0 (0.5) | 0.66 | 0.32 | 0.90 | |
| Mean Hit Latency | 74.6 (7.0) | 76.4 (6.0) | 70.1 (5.6) | 76.9 (5.0) | 0.73 | 0.47 | 0.68 | |
| Tracking Distance | 5378.6 (2912.0) | 3571.0 (3071.3) | 5993.9 (2550.6) | 3650.7 (3335.3) | 0.91 | 0.49 | 0.93 | |
| DSST | ||||||||
| Total Attempted | 62.2 (3.5) | 65.8 (4.7) | 53.8 (3.6) | 57.6 (3.9) | 0.04° | 0.35 | 0.98 | |
| Total Correct | 57.4 (4.1) | 61.8 (5.0) | 51.6 (3.3) | 55.0 (3.7) | 0.13 | 0.35 | 0.90 | |
| Physiological Parameters | ||||||||
| Heart Rate (beats/min) | 86.2 (0.8) | 87.1 (0.8) | 85.1 (0.9) | 83.5 (0.8) | 0.35 | 0.78 | 0.43 | |
| Pupil Diameter (mm) | 4.1 (0.1) | 4.3 (0.1) | 3.7 (0.1) | 4.3 (0.1) | 0.25 | 0.00* | 0.03° | |
| Arterial Oxygen Saturation (% SpO2) | 98.2 (0.1) | 98.1 (0.1) | 98.3 (0.1) | 98.2 (0.1) | 0.63 | 0.64 | 1.00 | |
| Diastolic Pressure | 82.0 (0.9) | 82.6 (0.8) | 76.2 (1.0) | 77.6 (1.1) | 0.00* | 0.58 | 0.79 | |
| Systolic Pressure | 131.52 (1.5) | 130.6 (1.3) | 121.9 (1.4) | 125.7 (1.2) | 0.01* | 0.50 | 0.18 | |
°
p<0.05,
*
p<0.01
Divided Attention Task; DEQ: Drug Effects Questionnaire; DSST: Digit Symbol Substitution Test; SOWS: Subjective Opiate Withdrawal Scale; VAS: Visual Analogue Scales