The Economic Effects of Psychedelics

Last registered on January 09, 2023

Pre-Trial

Trial Information

General Information

Title
The Economic Effects of Psychedelics
RCT ID
AEARCTR-0010400
Initial registration date
November 21, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
November 30, 2022, 2:42 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
January 09, 2023, 4:31 PM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

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Primary Investigator

Affiliation
UBC

Other Primary Investigator(s)

PI Affiliation
University of British Columbia
PI Affiliation
University of British Columbia
PI Affiliation
University of British Columbia

Additional Trial Information

Status
In development
Start date
2022-11-21
End date
2023-12-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Recent clinical trials find transformative effects of psychedelic drugs on mental health, prosociality, and spirituality. These findings have broad-ranging implications for policy, with some polities now decriminalizing psychedelics, and some psychedelic-assisted therapies close to receiving approval for mass use. Despite these high stakes, existing evidence suffers from three glaring omissions. First, existing clinical trials use very small samples. Second, we know little of the effects of psychedelics outside of controlled clinical settings. Third, no work estimates effects on economic outcomes. We address these omissions with an RCT in collaboration with a large ayahuasca center in Brazil.
External Link(s)

Registration Citation

Citation
Francois, Patrick et al. 2023. "The Economic Effects of Psychedelics ." AEA RCT Registry. January 09. https://doi.org/10.1257/rct.10400-1.1
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2022-11-21
Intervention End Date
2023-12-31

Primary Outcomes

Primary Outcomes (end points)
Measured about 3 days after treatment
- Depression score, happiness, flourishing
- Self-reported prosociality, moral universalism, and social image concerns
- Work-related outcomes (e.g. work satisfaction, intentions to leave job and to change career)
- Schwartz values questions
- First-stage outcomes with respect to their experience with Ayahuasca: Ego Dissolution Scale; Mystical Experience Questionnaire; Meaningfulness of Experience
- Trip characteristics (e.g. what they tripped on, qualitative information on their experience)

Measured about 6 weeks after treatment
- Similar to the measures above, but some questions dropped and some added
- Dropped: Schwartz values questions, first-stage ayahuasca experience measures (except meaningfulness of experience), trip characteristics
- Added: dictator game, major decisions, what would you choose vs. what would make you happy, whether relationship mentioned at baseline has improved, work hours, measures of self-knowledge, and incentivized measure of social image concerns

Measured 2, 4, and 6 weeks after treatment
-Instagram posting behaviours

Measured four to six months after treatment (funding permitting)
- Similar measures as after 6 weeks
Primary Outcomes (explanation)
Depression and happiness are measured by, respectively, employing the Kessler Psychological Distress Scale (K10) and self-reported happiness on a scale from 1 to 7. We also elicit key first-stage measures to compare our participants’ experiences with the literature on clinical trials. For this matter, we use the Ego Dissolution Inventory (Nour et al. 2016), the Mystical Experience Questionnaire (Pahnke WN 1969), and a Meaningful Experience question (as in Griffiths 2006).

Secondary Outcomes

Secondary Outcomes (end points)
Measured about 3 days after treatment
- Self-awareness
- Predicted happiness
- Social image concerns with respect to revealing on social media about their experience with Ayahuasca
- Dreams characteristics (e.g. whether dreamed, whether dreams were positive)
- Self-reported competitiveness

Measured about 6 weeks after treatment
- Creativity
- Whether dreamed
- Religiosity and spirituality
- Predicted study effects on depression
- Overall health self-evaluation
- Behavioural change self-report

Measured four to six months after treatment (funding permitting)
- Similar measures as after 6 weeks
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We are partnering with an Ayahuasca center in Brazil, where ayahuasca has been legal for ritualistic purposes since 2010. Our partner will recruit adults who have never taken ayahuasca before, screening people based on disease history, as is their standard practice. For safety, those with severe depression, or a family history of bipolar or schizophrenic disorders are not allowed to participate. Recruitment will happen on a rolling basis, as per the center’s status quo. Our goal is to recruit about ≈500 participants split across ≈15 sessions, averaging 33 participants per session. However, the final number of participants will hinge on how many first-timers the center can successfully recruit.

The randomization will be performed by our partner, and our only role is to administer the surveys. Participants will be randomly assigned to one of two groups upon arrival at the center: (i) take a regular dose of ayahuasca, offered in their usual ayahuasca sessions, with 3:1 concentration of ayahuasca:water, or (ii) take a less concentrated dose of ayahuasca, with 1:1 of concentration ayahuasca:water. To guarantee there is no selection into treatment, the study will be single-blinded (i.e. participants will not be informed about their treatment assignment until they fill out the last survey).

The sessions are preceded by a ≈15 minutes lecture given by the center’s owners. The lectures could be about either (i) happiness and pleasure or (ii) taming the mind. They will alternate which lectures are taught in each of the study sessions, allowing us to estimate suggestive effects of the lecture type on the nature of trips, and to explore treatment effect heterogeneity by lecture type.

We will also survey participants who booked a session but canceled or did not show up to the ceremony. For them, we will be interested in outcomes we measure at baseline, such as depression, (predicted) happiness, and work satisfaction. This group will be our “pure control group,” though given selection into the group, we will use a difference-in-difference approach for suggestive evidence of effects of the placebo relative to the pure control.

Randomization is stratified by sex, and it takes place when participants’ list for each study session has been closed (i.e. about one day before a study session). The center will perform the randomization by generating random numbers in a spreadsheet, allowing us to validate whether the randomization was implemented correctly.
Experimental Design Details
Not available
Randomization Method
Randomization done in office by a computer.
Randomization Unit
Individual level
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
10-20 sessions
Sample size: planned number of observations
300-600 participants
Sample size (or number of clusters) by treatment arms
150-300 participants in each treatment arm (i.e. regular ayahuasca concentration versus lower ayahuasca concentration)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
University of British Columbia Office of Research Ethics
IRB Approval Date
2022-08-22
IRB Approval Number
H21-00789