Table 2.
Peak values calculated during Phase 1 Over Days 1-3
| Peak maximum values: | Placebo (n=12) |
T 200 mg (n=12) |
T 600 mg (n=12) |
p value |
|---|---|---|---|---|
| Withdrawal measures: | ||||
| Subject-rated adjectives total | 23.1 (4.3) | 19.2 (2.4) | 24.5 (3.5) | - |
| Observer-rated adjectives total | 13.3 (2.1) | 13.6 (3.3) | 12.4 (1.2) | - |
| -Sneezing | 1.2 (0.3) | 0.3 (0.2) | 0.0 (0.0) | 0.003 |
| SOWS total | 10.2 (1.9) | 8.1 (1.0) | 10.8 (1.3) | - |
| -Muscular Tension | 1.3 (0.3) | 0.6 (0.2) | 1.3 (0.3) | 0.048 |
| -Insomnia | 1.8 (0.3) | 1.0 (0.3) | 2.1 (0.2) | 0.036 |
| OOWS total | 4.9 (0.6) | 5.4 (0.8) | 4.8 (0.4) | - |
| -Lacrimation | 0.7 (0.1) | 0.2 (0.1) | 0.3 (0.1) | 0.037 |
| Himmelsbach total | 5.5 (0.6) | 5.5 (0.6) | 4.8 (0.3) | - |
| -Lacrimation | 1.1 (0.2) | 0.3 (0.2) | 0.5 (0.2) | 0.028 |
| VAS medication items: | ||||
| Helping withdrawal | 36.6 (8.7) | 46.9 (9.5) | 46.1 (11.7) | - |
| Side effects | 5.9 (3.2) | 6.2 (4.9) | 9.5 (7.5) | - |
| Any drug effect | 28.8 (7.3) | 36.9 (9.3) | 42.2 (11.5) | - |
| High | 0.7 (0.5) | 0.0 (0.0) | 6.5 (5.8) | - |
| Good effects | 37.8 (8.5) | 39.4 (9.4) | 43.8 (12.0) | - |
| Like | 30.5 (9.2) | 39.6 (9.5) | 39.5 (11.9) | - |
| Bad effects | 8.6 (3.9) | 7.3 (5.7) | 10.2 (7.1) | - |
| Feel sick | 9.3 (8.3) | 6.2 (5.6) | 5.5 (5.4) | - |
| Crave | 8.4 (5.7) | 6.7 (6.7) | 5.8 (5.7) | - |
| MPQ Total | 16.9 (3.9) | 15.6 (4.0) | 13.4 (2.6) | - |
| BDI Total | 11.8 (1.4) | 11.0 (2.5) | 8.3 (2.1) | - |
| VAS Desire opiates | 71.7 (8.6) | 82.5 (5.9) | 89.3 (5.0) | - |
| Street value ($) | 2.2 (0.9) | 1.8 (1.0) | 1.6 (0.6) | - |
| Physiologic measures: | ||||
| SBP (mm Hg) | 142.6 (4.5) | 130.9 (4.3) | 137.9 (4.1) | - |
| DBP (mm Hg) | 84.7 (2.5) | 79.3 (2.9) | 78.8 (2.4) | - |
| Heart Rate (bpm)* | 19.3 (3.5) | 14.6 (3.5) | 3.7 (1.4) | 0.002 |
| Temperature (F) | 98.8 (0.2) | 98.6 (0.2) | 98.3 (0.2) | - |
| Respiratory rate nadir | 13.6 (0.2) | 12.7 (0.4) | 13.7 (0.4) | - |
| Pupil diameter max (mm) | 5.8 (0.2) | 6.0 (0.2) | 5.2 (0.2) | 0.032 |
| Pupil diameter nadir (mm) | 3.7 (0.2) | 4.2 (0.3) | 3.1 (0.1) | 0.003 |
| DSST accuracy nadir (%) | 88.5 (2.4) | 85.6 (3.2) | 88.8 (2.3) | - |
Data are peak max means (SE) unless otherwise indicated. Doses listed are extended release tramadol total daily doses.
*
indicates peak change from baseline. Bolded value indicates significant Dunnett compared to placebo. - indicates insignificant ANOVA group p value.