Riba · Psychopharmacology 2001 · single-blind crossover placebo-controlled trial · n=6

Subjective effects and tolerability of the South American psychoactive beverage Ayahuasca in healthy volunteers.

Cited 303 times in the scientific literature.

Level 2 - randomized trial

Single-blind crossover placebo-controlled randomized clinical trial

PubMed 11292011 · doi:10.1007/s002130000606 · record verified 2026-08-28

What was done

Six healthy male volunteers with prior experience using ayahuasca received three increasing doses of encapsulated freeze-dried ayahuasca (0.5, 0.75, and 1.0 mg DMT/kg body weight) or placebo in a single-blind, crossover, placebo-controlled clinical trial. Psychological effects and tolerability were assessed using the Hallucinogen Rating Scale, the Addiction Research Center Inventory, and visual analogue scales.

What was found

Ayahuasca produced significant dose-dependent increases in five of the six subscales of the Hallucinogen Rating Scale, in three scales of the Addiction Research Center Inventory (LSD, MBG, and A), and in visual analogue scales measuring liking, good effects, and high (exact numerical values not reported in abstract). Subjective effects began after 30 to 60 minutes, peaked between 60 and 120 minutes, and resolved by 240 minutes. Cardiovascular tolerability was acceptable, showing a trend toward increased systolic blood pressure. Somatic effects commonly included modified physical sensations and nausea. Five of six volunteers regarded the experience as pleasant, while one volunteer experienced an intensely dysphoric reaction with transient disorientation and anxiety at the medium dose and withdrew from the study.

Why it matters

This study provides early controlled human clinical data on the time course, dose-dependent psychological effects, and safety profile of oral encapsulated ayahuasca.

Limits

The trial had an extremely small sample size (n = 6) and included only healthy male participants with previous ayahuasca experience. The design was single-blind rather than double-blind, and the abstract reports no exact numerical data, variance, or confidence intervals.

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