Table 1.
Descriptive Summary of Included Studies
| Study | Sample | Primary Outcome | Na | Study Design | Drug Dose | Therapy Only Sessions (# / hours)bc | Dosing Sessionsb | Control Group | Primary End-point | % Women | Mean Age | % White |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Danforth et al. (2018) | Socially anxious adults with autism | Social Anxiety (LSAS) | 11 (MDMA n = 7; placebo n = 4) | Double-blind, randomized, placebo-controlled, parallel arm | MDMA (75-125 mg) | 9 / Mean = 11.3 | 3 | Inert placebo | 1-month after 2nd experimental session | 16.7 | 31.3 | 50.0 |
| Gasser et al. (2014) | Anxiety associated with life-threatening illness | Anxiety (STAI-state and trait) | 11 (LSD n = 8; placebo n = 3) | Double-blind, randomized, placebo-controlled, open-label cross-over | LSD (200 μg) | Unclear | 2 | Low-dose psychedelic (20 μg LSD) | 2-month after 2nd blinded session | 36.4 | 51.7 | Not reported |
| Griffiths et al. (2016) | Life-threatening cancer; depression and/or anxiety | Depression (HAM-D) & Anxiety (HAM-A) | 50 (High dose first n = 25; low dose first n = 25) | Double-blind, randomized, placebo-controlled, cross-over | Psilocybin (22 mg or 30 mg/70 kg) | Mean = 4.0 / Mean = 9.1 | 1 | Low-dose psychedelic (1 or 3 mg/70 kg psilocybin) | 5-weeks after session 1 | 51.0 | 56.3 | 94 |
| Mithoefer et al. (2011) | Chronic PTSD | PTSD (CAPS-IV) | 20 (MDMA n = 12; placebo n = 8) | Double-blind, randomized, placebo-controlled, open-label cross-over | MDMA (125 mg; optional 65 mg supplemental) | 10 / 15.0 | 2 | Inert placebo | 3-5 days after session 2 | 85.0 | 40.4 | 100.0 |
| Mithoefer et al. (2018) | Chronic PTSD | PTSD (CAPS-IV) | 26 (MDMA 125 /75 mg combined n = 19; MDMA 30 mg n = 7) | Double-blind, randomized, placebo-controlled, open-label cross-over | MDMA (75 mg or 125 mg) | 9 / 13.5 | 2 | Low-dose psychedelic (30 mg MDMA) | 1-month after experimental session 2 | 26.9 | 37.2 | 84.6 |
| Oehen et al. (2013) | Chronic PTSD | PTSD (CAPS-IV) | 12 (MDMA n = 8; placebo n = 4) | Double-blind, randomized, placebo-controlled, open-label cross-over | MDMA (125 mg, 62.5 mg supple-mental) | Mean = 13.30 / Unclear | 3 | Low-dose (25 mg) psychedelic; supplemental (12.5 mg) dose | 3-weeks after experimental session 3 | 83.3 | 41.4 | Not reported |
| Ot’alora et al. (2018) | Chronic PTSD | PTSD (CAPS-IV) | 23 (MDMA 125/100 mg combined n = 18; MDMA 40 mg n = 5) | Double-blind, randomized, open-label cross-over | MDMA (125 or 100 mg) | Unclear | 2 | Low-dose psychedelic (40 mg MDMA) | 1-month after 2nd blinded session | 32.1 | 42.0 | 92.9 |
| Palhano-Fontes et al. (2019) | Treatment-resistant major unipolar depressive disorder | Depression (HAM-D) | 29 (Ayahuasca n = 14; placebo n = 15) | Double-blind, randomized, placebo-controlled, parallel arm | Ayahuasca (containing 0.36 mg/kg of N, N-DMT) | Unclear | 1 | Liquid causing mild gastric distress; matched for taste/color | 1-week | 72.4 | 42.0 | 58.6 |
| Ross et al. (2016) | Life-threatening cancer; anxiety diagnosis | Anxiety and Depression (HADS) | 29 (Psilocy-bin 1st n = 14; niacin 1st n = 15) | Double-blind, randomized, placebo-controlled, cross-over | Psilocybin (0.3 mg/kg) | 6 / 12.0 | 1 | Niacin | 1-day after dose one | 62.1 | 56.3 | 89.7 |
Note.
a
= sample size at primary endpoint;
b
= data before primary endpoint;
c
= estimates of sessions/hours are best estimates as this information was not always clearly specified within papers;
CAPS-IV = Clinician Administered PTSD Scale – IV (Blake Weathers Nagy Kaloupek Gusman Charney and Keane 1995); GRID-HAMD = GRID-Hamilton Depression Rating Scale (Williams et al. 2008), HADS = Hospital Anxiety and Depression Scale (Zigmond and Snaith 1983); HAM-A = Hamilton Anxiety Rating Scale (Bruss Gruenberg Goldstein and Barber 1994); HAM-D = Hamilton Depression Rating Scale (Hamilton 1960); LSAS = Liebowitz Social Anxiety Scale (Liebowitz Gorman Fyer and Klein 1985)