Table 3.
Peak values calculated during Phase 2 over Days 8-13
| Peak maximum values: | Placebo (n=12) |
T 200 mg (n=12) |
T 600 mg (n=12) |
p value |
|---|---|---|---|---|
| Withdrawal measures: | ||||
| Subject-rated adjectives total | 7.4 (2.2) | 7.5 (1.9) | 10.5 (1.8) | - |
| -Hot/cold | 0.0 (0.0) | 0.3 (0.1) | 0.5 (0.2) | - |
| Observer-rated adjectives total | 7.2 (0.8) | 7.8 (1.5) | 9.7 (1.3) | - |
| -Heavy/sluggish | 1.2 (0.3) | 1.3 (0.1) | 2.1 (0.2) | 0.014 |
| -Irritable | 0.6 (0.2) | 0.3 (0.1) | 1.6 (0.4) | 0.003 |
| -Depressed | 0.6 (0.2) | 0.9 (0.3) | 1.4 (0.2) | - |
| SOWS total | 3.4 (1.1) | 3.0 (1.0) | 4.8 (0.9) | - |
| Himmelsbach total | 4.8 (0.5) | 4.7 (0.7) | 5.3 (0.5) | - |
| -Rhinorrhea | 1.1 (0.2) | 1.4 (0.2) | 1.7 (0.1) | - |
| VAS medication items: | ||||
| Helping withdrawal | 23.1 (10.9) | 28.4 (10.6) | 28.7 (9.8) | - |
| Side effects | 8.9 (8.3) | 0.0 (0.0) | 1.6 (1.3) | - |
| Any drug effect | 24.5 (10.6) | 30.4 (10.4) | 27.8 (9.3) | - |
| High | 0.0 (0.0) | 0.0 (0.0) | 0.0 (0.0) | - |
| Good effects | 26.3 (10.5) | 30.4 (10.6) | 28.1 (9.2) | - |
| Like | 25.5 (10.6) | 24.3 (8.7) | 23.8 (9.2) | - |
| Bad effects | 8.8 (8.3) | 0.4 (0.4) | 0.8 (0.6) | - |
| Feel sick | 1.5 (1.5) | 0.1 (0.1) | 0.0 (0.0) | - |
| Crave | 1.3 (1.3) | 9.7 (5.9) | 4.8 (4.8) | - |
| MPQ total | 6.3 (2.3) | 8.3 (2.6) | 9.8 (3.0) | - |
| BDI total | 7.4 (1.4) | 7.8 (2.1) | 6.8 (2.1) | - |
| VAS desire opiates | 52.6 (10.5) | 37.6 (10.1) | 58.8 (11.1) | - |
| Street value ($) | 1.4 (0.6) | 1.8 (1.1) | 1.1 (0.6) | - |
| Physiologic measures: | ||||
| SBP (mm Hg) | 140.9 (3.5) | 138.5 (4.2) | 140.8 (3.8) | - |
| DBP (mm Hg) | 82.6 (2.3) | 84.0 (2.1) | 84.8 (2.0) | - |
| Heart rate (bpm) | 99.5 (2.7) | 98.3 (2.3) | 101.8 (1.6) | - |
| Temperature (F) | 98.8 (0.1) | 98.8 (0.1) | 99.0 (0.1) | - |
| Respiratory rate nadir | 13.3 (0.3) | 13.2 (0.3) | 13.0 (0.3) | - |
| Pupil diameter max (mm) | 5.7 (0.2) | 5.9 (0.2) | 5.6 (0.1) | - |
| Pupil diameter nadir (mm) | 3.5 (0.2) | 3.6 (0.2) | 3.2 (0.2) | - |
| DSST accuracy nadir (%) | 90.3 (1.6) | 87.2 (2.5) | 89.0 (1.9) | - |
Data are peak max means (SE) unless otherwise indicated. Doses listed are Phase 1 extended release tramadol total daily doses before crossing over to placebo. - indicates insignificant ANOVA group effect p value. Bolded value indicates significant Dunnett comparison to placebo.