The Effect of LSD on Neural Synchrony, Prosocial Behavior, and Relationship Quality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-01

Brief Summary

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The goal of this study is to assess the effects of LSD on neural synchrony, prosocial behavior, and relationship quality in healthy romantic couples.

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Detailed Description

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Evidence is growing that psychedelic substances such as psilocybin, lysergic acid diethylamide (LSD) and ayahuasca could be a potential alternative treatment option for common and difficult to treat psychiatric conditions. One proposed mechanism that psychedelics target, which is a hallmark of seemingly all psychiatric disorders, are deficits in social cognitive abilities. However, the neural underpinnings of psychedelic induced alterations in prosocial behavior are currently unknown. The investigators hypothesize psychedelics increase such prosocial behaviors by increasing neural synchrony, which is the coupling of brain-to-brain activity across two or more people; it has been found to underlie social connection and various forms of shared prosocial behavior.

The current project will primarily assess whether LSD enhances neural synchrony between romantic partners. Second, the investigators will assess whether LSD enhances prosocial behavior between members of a dyad, thus replicating previous studies which assessed prosocial behavior within one individual at a time. The investigators will also assess the relationship between neural synchrony and outcome variables of the prosocial behaviour tasks. Lastly, it will be assessed whether LSD-induced changes in neural synchrony and/or prosocial behaviour affect persisting relationship quality. Oxytocin and cytokine concentrations, will also be quantified to investigate whether there is a relationship between these factors and changes in prosocial behaviour.

The study design will be conducted according to a double-blind, placebo-controlled, 2-way crossover design. Healthy participants (N=60) who are in a relationship (N=30 couples) will receive placebo and an oral dose of 50 µg of LSD. Between each condition, there will be a minimum of 14 days washout. This leads to a total study duration of minimally four weeks, for a participant to go through the medical examination and both drug conditions.

Conditions

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Prosocial Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

LSD and placebo will be administered in an AB or BA sequence, with half of the couples following sequence AB and the other half following sequence BA. Couples will receive an oral dose of either 50 µg of LSD or placebo. All couples will receive both the LSD and the placebo solution on separate dosing days with follow-ups 2 days later (in the lab), and 4 days later (at home). There will be a 14-day washout period between drug administrations.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Random allocation of couples to a the treatment order will be done using Sealedenvelope software, by one experimenter who does not come in direct contact with the participants. The study will be double blind to the subject and the testing experimenter. One experimenter will be responsible for preparing the LSD. This experimenter will not be the one testing the participants. If a subject is withdrawn from the study they will be replaced, for a maximum of n=60 participants (n=30 couples). Following completion of all data collection the study will be fully unblinded.

Study Groups

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LSD condition

60 participants will receive LSD.

Group Type EXPERIMENTAL

LSD

Intervention Type DRUG

Single dose of LSD (50 µg) will be administered in a small amount of alcohol (ethanol, 2ml/95% Vol.) orally.

Ethanol condition

60 participants will receive placebo.

Group Type PLACEBO_COMPARATOR

Ethanol

Intervention Type DRUG

Identical ampules containing pure ethanol without the investigational product will be used (1mL ethanol, 95% Vol.).

Interventions

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LSD

Single dose of LSD (50 µg) will be administered in a small amount of alcohol (ethanol, 2ml/95% Vol.) orally.

Intervention Type DRUG

Ethanol

Identical ampules containing pure ethanol without the investigational product will be used (1mL ethanol, 95% Vol.).

Intervention Type DRUG

Other Intervention Names

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lysergic acid diethylamide

Eligibility Criteria

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Inclusion Criteria

* Written Informed Consent
* Understanding the procedures and the risks associated with the study.
* Age between 18 and 35 years old.
* Being in a steady relationship for at least 6 months.
* Proficient knowledge of the English language
* Previous experience with at least one psychedelic drug (psilocybin, LSD, mescaline, Ayahuasca, DMT, 5-MeO-DMT), but not within the past 3 months
* Absence of any major medical condition as determined by medical examination and laboratory analysis
* Absence of any major psychological condition as determined by medical examination
* Free from psychotropic medication
* Participants must be willing to refrain from taking illicit psychoactive substances during the study.
* Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
* Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.
* Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2

Exclusion Criteria

* History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
* Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)
* Pregnancy or lactation
* Hypertension (diastolic \> 90 mmHg; systolic \> 140 mmHg)
* Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
* Psychotic disorder in first-degree relatives
* Any chronic or acute medical condition
* History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…)
* For women: no use of a reliable contraceptive
* Tobacco smoking (\>20 per day)
* Excessive drinking (\>20 alcoholic consumptions per week)
* Experience with a full dose of a psychedelic within the last three months
* Current use of SSRI medication

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes