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

NCT05670184 | Unknown Phase 1

• 1 other identifier: NL80435.068.22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prosocial Behavior

Outcome Measures

Primary Outcomes (1)

• Neural synchrony

  Quantification of neural synchrony between members of a couple utilizing previously validated naturalistic interaction paradigms, including a motor cooperation task, empathy giving task, and affective touch and eye contact paradigm, will be employed. Resting state EEG will be used as a control.

  On the acute dosing test day, 1.5-2 hours after substance administration

Secondary Outcomes (8)

• Empathy

  On the acute dosing test day, 2 hours (EGT) and 3 hours (MET) after substance administration

• Self-other distinction

  On the acute dosing day, 2.5 hours (SMS) after substance administration. The OIS will be administered repeatedly at baseline (-0.5 hours), 2 hours, 3 hours, 4.5 hours, and 7 hours after substance administration, and at 2 days follow up.

• Prosocial behavior

  On the acute dosing day, 6 hours after substance administration. The PET will also be administered at 2 days follow-up.

• Social influence processing

  On the acute dosing day, 3 hours after substance administration

• Trust

  On the acute dosing day, 6.5 hours after substance administration

Other Outcomes (10)

• Relationship quality

  At baseline, 2 days follow-up (CSI) and at 4 days follow-up (CSI, PPRS, ECR, IRI-C).

• Sexual function

  At baseline, 2 days follow-up (GMSEX), and at 4 days follow-up (GMSEX, FSFI/IIEF).

• Well-being

  On the acute dosing day, at baseline (-0.5 hours) and at 7 hours after substance administration, at the 2 day follow-up, and at the 4 day follow-up.

Study Arms (2)

LSD condition

EXPERIMENTAL

60 participants will receive LSD.

Drug: LSD

Ethanol condition

PLACEBO COMPARATOR

60 participants will receive placebo.

Drug: Ethanol

Interventions

LSD DRUG

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

Also known as: lysergic acid diethylamide

LSD condition

Ethanol DRUG

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

Ethanol condition

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Altruism

Interventions

Lysergic Acid Diethylamide; Ethanol

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Alcohols; Organic Chemicals

Study Officials

• Johannes G Ramaekers, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Mason, PhD

CONTACT

+31 43 3881382; natasha.mason@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: January 4, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 4, 2023

Record last verified: 2022-11

Locations

NL (1)