| Screening | Baseline | Preparation 1 | Preparation 2 | Dosing | Integration 1 | Integration 2 | 4-week endpoint | 6-month follow-up |
---|---|---|---|---|---|---|---|---|---|
Days relative to dosing |  | -20 | -7 | -1 | 0 | + 1 | + 7 | + 35 | + 190 |
Key assessments | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â |
Psychiatric screening | X | Â | Â | Â | Â | Â | Â | Â | Â |
Physical screening | X | Â | Â | Â | Â | Â | Â | Â | Â |
Key outcomes | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Clinical outcomes | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Heavy drinking | Â | X | Â | Â | Â | Â | Â | X | X |
Drinking days | Â | X | Â | Â | Â | Â | Â | X | X |
Abstinence | Â | X | Â | Â | Â | Â | Â | X | X |
PEth | Â | Â | Â | Â | Â | Â | Â | X | Â |
Mood | Â | X | Â | X | Â | Â | X | X | X |
Anxiety | Â | X | Â | X | Â | Â | X | X | X |
Trauma | Â | X | Â | X | Â | Â | X | X | X |
Global functioning | Â | X | Â | Â | Â | Â | Â | X | X |
Safety | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Adverse events | Â | X | X | X | X | X | X | X | X |
Feasibility | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Insclusion rates | X | Â | Â | Â | Â | Â | Â | Â | Â |
Retention rates | Â | Â | X | X | X | X | X | X | X |
Neurocog. outcomes | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Neuroplasticity (LTP) | Â | Â | X | Â | Â | X | X | Â | Â |
Cue reactivity | Â | Â | X | Â | Â | X | X | Â | Â |
Inhibition | Â | Â | X | Â | Â | X | X | Â | Â |
Drug experience | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Mystical (MEQ) | Â | Â | Â | Â | X | Â | Â | Â | Â |
Acceptance/Avoidance (APEQ) | Â | Â | Â | Â | X | Â | Â | Â | Â |
Trauma access/process. (Helioscope Q.) | Â | Â | Â | Â | X | Â | Â | Â | Â |
Psychological processes | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Flexibility (AAQQ II) | Â | X | Â | X | Â | Â | X | X | X |
Interoception (MAIA) | Â | X | Â | X | Â | Â | X | X | X |
Connectedness (WCS) | Â | X | Â | X | Â | Â | X | X | X |
Alcohol-related parameters | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Craving (PACS) | Â | X | Â | X | Â | Â | X | X | X |
Abstinence self-efficacy (AASE) | Â | X | Â | X | Â | Â | X | X | X |
Readiness to change | Â | X | Â | X | Â | Â | X | X | X |