Clinical TrialAlcohol Use Disorder (AUD)Completed

Single Dose Ayahuasca in College Students With Harmful Alcohol Use: A Single-blind Feasibility Trial (Rodrigues 2024, USP Brazil)

This unregistered trial (n=11) was a single-blind, feasibility, proof-of-concept study of a single dose of ayahuasca for harmful alcohol use in college students, which demonstrated the protocol's feasibility and safety.

Ask Blossom about this trial
Target Enrollment
11 participants
Study Type
interventional
Design
Non-randomized

Detailed Description

This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found. This single-blind, feasibility study investigated the effects of a single oral dose of ayahuasca, accompanied by psychological support but without formal psychotherapy, on the drinking patterns of 11 college students experiencing harmful alcohol consumption.

The primary outcome measured was the number of days of alcohol consumption per week during weeks two and three following administration. Secondary variables included safety, tolerability, craving, personality, anxiety, impulsivity, self-esteem, and social cognition.

Results indicated that ayahuasca was well tolerated with no serious adverse reactions observed. While a reduction in the frequency of alcohol consumption was noted between weeks two and three, this finding did not remain statistically significant after Bonferroni correction. Other secondary measures, including craving and anxiety, showed no significant changes.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment11 participants
  • Timeline
    Start: 2022-01-01
    End: 2024-01-01
  • Topic
    Alcohol Use Disorder (AUD)

Locations

Brazil

Related Publications

PaywallindividualPrimary

Effects of a Single Dose of Ayahuasca in College Students With Harmful Alcohol Use: A Single-blind, Feasibility, Proof-of-Concept Trial

In a single-blind proof-of-concept trial in 11 college students with harmful alcohol use, one dose of ayahuasca with psychological support was well tolerated and produced a short-term reduction in days drinking at 2–3 weeks that did not survive correction for multiple comparisons. The study demonstrates feasibility of the protocol and supports larger, controlled trials to assess efficacy.

Published
Journal
Journal of Clinical Psychopharmacology
Authors
Rodrigues, L. S., Rossi, G. N., Guerra, L. T. L., Maekawa, R. M., de Lima Osório, F., Bouso, J. C., Dos Santos, R. G., Santos, F. P., Paranhos, B. A. P. B., Yonamine, M., Hallak, J. E.