Table 1.
Placebo | 125 mg R-MDMA | 250 mg R-MDMA | 125 mg MDMA | 125 mg S-MDMA | F4, 92 | P= | Pla - R-MDMA (125 mg) | Pla - R-MDMA (250 mg) | Pla - MDMA | Pla - S-MDMA | R-MDMA (125 mg) - R-MDMA (250 mg) | R-MDMA (125 mg) - MDMA | R-MDMA (125 mg) - S-MDMA | R-MDMA (250 mg) - MDMA | R-MDMA (250 mg) - S-MDMA | MDMA - S-MDMA | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean ± SEM | Mean ± SEM | Mean ± SEM | Mean ± SEM | Mean ± SEM | ||||||||||||||
Visual Analog Scale (VAS, %max) | ||||||||||||||||||
Unidirectional scales (0–100) | ||||||||||||||||||
Any drug effect | ΔEmax | 4.8 ±2.1 | 42 ±7.3 | 66 ±6.1 | 77 ±5.3 | 90 ±3.1 | 68.92 | <0.001 | *** | *** | *** | *** | *** | *** | *** | NS | ** | NS |
Good drug effect | ΔEmax | 7.9 ±4.1 | 43 ±7.1 | 68 ±6.6 | 78 ±5.1 | 90 ±3.8 | 54.97 | <0.001 | *** | *** | *** | *** | *** | *** | *** | NS | ** | NS |
Bad drug effect | ΔEmax | 0.5 ±0.3 | 14 ±5.1 | 19 ±4.6 | 20 ±5.9 | 39 ±7.0 | 10.51 | <0.001 | NS | * | * | *** | NS | NS | *** | NS | * | * |
I like the effect | ΔEmax | 7.7 ±3.8 | 47 ±7.1 | 68 ±6.6 | 81 ±5.0 | 91 ±3.6 | 60.12 | <0.001 | *** | *** | *** | *** | ** | *** | *** | NS | ** | NS |
Stimulated | ΔEmax | 2.5 ±1.1 | 31 ±6.9 | 60 ±6.7 | 70 ±6.7 | 88 ±3.7 | 58.82 | <0.001 | *** | *** | *** | *** | *** | *** | *** | NS | *** | NS |
Drug high | ΔEmax | 1.4 ±0.6 | 29 ±7.0 | 48 ±7.6 | 73 ±6.7 | 84 ±5.1 | 49.31 | <0.001 | *** | *** | *** | *** | * | *** | *** | ** | *** | NS |
Fear | ΔEmax | 0.0 ±0.0 | 4.9 ±4.2 | 5.8 ±3.4 | 5.9 ±3.4 | 19 ±6.9 | 3.90 | 0.006 | NS | NS | NS | ** | NS | NS | * | NS | NS | NS |
Alteration of vision | ΔEmax | 3.0 ±1.6 | 24 ±6.9 | 37 ±6.7 | 54 ±7.8 | 74 ±6.7 | 32.23 | <0.001 | * | *** | *** | *** | NS | *** | *** | NS | *** | * |
Alteration of sense of time | ΔEmax | 2.2 ±2.0 | 28 ±7.2 | 46 ±7.7 | 60 ±6.8 | 73 ±6.6 | 34.55 | <0.001 | ** | *** | *** | *** | NS | *** | *** | NS | ** | NS |
Audio-visual synesthesia | ΔEmax | 4.6 ±4.2 | 15 ±5.9 | 31 ±6.8 | 29 ±6.8 | 53 ±8.3 | 16.01 | <0.001 | NS | ** | ** | *** | NS | NS | *** | NS | ** | ** |
Ego dissolution | ΔEmax | 1.5 ±0.8 | 22 ±7.4 | 32 ±7.4 | 41 ±7.7 | 58 ±8.2 | 17.83 | <0.001 | * | *** | *** | *** | NS | NS | *** | NS | ** | NS |
Bidirectional scales (−50 to 50) | ||||||||||||||||||
Happy | ΔEmax | 3.9 ±2.2 | 14 ±3.5 | 24 ±3.8 | 34 ±3.3 | 38 ±3.4 | 32.25 | <0.001 | * | *** | *** | *** | NS | *** | *** | * | *** | NS |
Content | ΔEmin | 4.8 ±2.2 | 19 ±3.4 | 30 ±3.6 | 39 ±2.8 | 44 ±2.5 | 46.83 | <0.001 | *** | *** | *** | *** | * | *** | *** | * | *** | NS |
Talkative | ΔEmax | 2.8 ±1.6 | 13 ±3.2 | 22 ±3.9 | 35 ±3.6 | 37 ±3.9 | 30.55 | <0.001 | NS | *** | *** | *** | NS | *** | *** | ** | ** | NS |
Open | ΔEmax | 4.3 ±2.3 | 15 ±3.4 | 28 ±3.9 | 40 ±2.9 | 42 ±2.9 | 50.64 | <0.001 | * | *** | *** | *** | ** | *** | *** | ** | *** | NS |
Trust | ΔEmax | 4.0 ±2.0 | 16 ±3.5 | 24 ±4.1 | 40 ±3.1 | 44 ±2.3 | 48.93 | <0.001 | ** | *** | *** | *** | NS | *** | *** | *** | *** | NS |
I feel close to others | ΔEmax | 0.8 ±0.4 | 14 ±3.1 | 23 ±3.9 | 34 ±3.3 | 41 ±3.4 | 43.83 | <0.001 | ** | *** | *** | *** | NS | *** | *** | ** | *** | NS |
I want to be alone | ΔEmax | 0.2 ±0.2 | 6.1 ±2.6 | 10 ±3.4 | 6.9 ±2.7 | 12 ±3.4 | 4.15 | 0.004 | NS | * | NS | ** | NS | NS | NS | NS | NS | NS |
I want to be with others | ΔEmax | 1.8 ±1.1 | 17 ±3.4 | 24 ±4.0 | 31 ±3.5 | 40 ±3.5 | 32.15 | <0.001 | *** | *** | *** | *** | NS | ** | *** | NS | *** | NS |
Autonomic effects | ||||||||||||||||||
Systolic blood pressure (mmHg) | Emax | 127 ±2.7 | 138 ±2.5 | 147 ±2.5 | 152 ±2.3 | 160 ±3.1 | 74.46 | <0.001 | *** | *** | *** | *** | *** | *** | *** | NS | *** | ** |
Diastolic blood pressure (mmHg) | Emax | 78 ±0.8 | 84 ±1.1 | 91 ±1.6 | 92 ±1.3 | 97 ±1.6 | 62.90 | <0.001 | *** | *** | *** | *** | *** | *** | *** | NS | *** | *** |
Mean arterial pressure (mmHg) | Emax | 94 ±1.0 | 101 ±1.4 | 108 ±1.8 | 111 ±1.3 | 117 ±1.9 | 93.43 | <0.001 | *** | *** | *** | *** | *** | *** | *** | NS | *** | *** |
Heart rate (beats/min) | Emax | 75 ±1.3 | 87 ±2.6 | 93 ±3.4 | 95 ±3.5 | 100 ±3.3 | 21.50 | <0.001 | *** | *** | *** | *** | NS | NS | *** | NS | NS | NS |
Rate pressure product (mmHg x bpm) | Emax | 9135 ±218 | 11565 ±476 | 12999 ±569 | 14018 ±662 | 15389 ±705 | 41.15 | <0.001 | *** | *** | *** | *** | NS | *** | *** | NS | *** | NS |
Body temperature (°C) | Emax | 37.1 ±0.06 | 37.4 ±0.09 | 37.5 ±0.09 | 37.6 ±0.08 | 37.7 ±0.10 | 10.25 | <0.001 | NS | *** | *** | *** | NS | NS | * | NS | NS | NS |
List of complaints (LC score) | ||||||||||||||||||
Acute adverse effects | 0–9 h | 0.5 ±0.5 | 9.4 ±1.8 | 14 ±1.9 | 10 ±1.7 | 13 ±1.5 | 21.58 | <0.001 | *** | *** | *** | *** | NS | NS | NS | NS | NS | NS |
Subacute adverse effects | 9–24 h | 0.1 ±0.5 | 6.7 ±1.9 | 8.2 ±1.5 | 5.4 ±1.3 | 7.2 ±1.4 | 8.95 | <0.001 | *** | *** | ** | *** | NS | NS | NS | NS | NS | NS |
Subacute adverse effects | 24–72 h | 1.3 ±0.7 | 6.9 ±1.8 | 6.0 ±1.7 | 5.1 ±1.6 | 10 ±2.2 | 6.05 | <0.001 | * | NS | NS | *** | NS | NS | NS | NS | NS | NS |
Becks depression-inventar (BDI) | ||||||||||||||||||
BDI Score | 24–72 h | 2.0 ±0.9 | 4.3 ±1.2 | 4.4 ±1.2 | 4.8 ±1.3 | 8.4 ±1.7 | 4.07 | 0.004 | NS | NS | NS | * | NS | NS | NS | NS | NS | NS |
Symptom checklist 90 R (SCL-90-R) | ||||||||||||||||||
GSI score | 24–72 h | 0.08 ±0.02 | 0.18 ±0.05 | 0.17 ±0.05 | 0.14 ±0.03 | 0.34 ±0.77 | 5.02 | 0.001 | NS | NS | NS | * | NS | NS | NS | NS | NS | NS |
Hormones and markers | ||||||||||||||||||
Oxytocin (pg/mL)α | ΔCmax | 2.9 ±1.9 | 48 ±13 | 178 ±22 | 296 ±33 | 436 ±40 | 66.2β | <0.001 | NS | *** | *** | *** | *** | *** | *** | ** | *** | *** |
Cortisol (nmol/L) | ΔCmax | −156 ±27 | 140 ±28 | 249 ±26 | 285 ±26 | 398 ±27 | 81.90 | <0.001 | *** | *** | *** | *** | ** | ** | *** | NS | *** | * |
Prolactin (µg/L) | ΔCmax | −6.5 ±2.0 | 13 ±4.5 | 35 ±5.5 | 39 ±7.1 | 53 ±8.5 | 32.20 | <0.001 | *** | *** | *** | *** | *** | ** | *** | NS | NS | ** |
NS not significant, ΔEmax maximal effect difference from baseline, ΔCmax maximal plasma concentrationfrom baseline, N = 24, αN = 20, β = F4,81.
*P < 0.05; **P < 0.01; ***P < 0.001.