Clinical TrialInterpersonal Functioning & Social ConnectednessLSDPlaceboUnknown status

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

This double-blind, placebo-controlled crossover trial (n=60) investigates the effects of LSD on neural synchrony, prosocial behavior, and relationship quality in healthy romantic couples.

Target Enrollment
60 participants
Study Type
Phase I/II interventional
Design
Randomized, double Blind

Detailed Description

This randomised, double-blind, placebo-controlled 2-way crossover tests whether a single oral 50 µg dose of LSD enhances neural synchrony and prosocial behaviour in romantic couples (30 dyads).

Primary outcomes assess brain-to-brain synchrony using neuroimaging during dyadic tasks; secondary measures include prosocial task performance, relationship quality at follow-up, oxytocin and cytokine assays, and safety/tolerability assessments.

Participants receive both LSD and placebo in AB/BA sequence with a minimum 14-day washout; follow-ups occur 2 days (in-lab) and 4 days (at home) after dosing.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

LSD

experimental

Single oral 50 µg LSD given in ethanol; part of 2-way crossover.

Interventions

  • LSD50 µg
    via Oral• single dose

    Administered in 2 mL 95% ethanol.

Placebo (ethanol)

inactive

Identical ampule containing ethanol without LSD.

Interventions

  • Placebo
    via Oral• single dose

    Identical ampule containing 1 mL 95% ethanol.

Participants

Ages
18 – 35
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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

Study Details

Locations

Maastricht University — Maastricht, Netherlands

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