Table 3 Lifestyle considerations

Caffeine

Limit caffeine consumption to ~ 100 mg on dosing day.

Alcohol

Abstain from alcohol for 24 h before the start of each first dosing session.

A breathalyser test will be performed at each dosing session. A failed breath alcohol test (> 0 µg/L breath) will lead to withdrawal.

Recreational drugs

Abstain from recreational drugs for the duration of the study.

Tobacco

Participants who use tobacco products will be instructed that use of nicotine-containing products (including nicotine patches) will not be permitted while they are at the study site.

Depression therapy

Not begin any new therapies for depression over the course of the study.

Menstruation

For persons who are menstruating, best efforts will be made to time the dosing session with the start of the follicular phase of the menstrual cycle, and participants will be asked to report the onset of menses during their participation.