drug effects not applicable
Conditions
Interventions
50 micrograms LSD dissolved in ethanol, resulting in a 1 mL solution, placebo
(1mL of ethanol) per oral
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Written Informed Consent Understanding the procedures and the risks associated with the study. Age between 18 and 40 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of neural synchrony (defined as EEG phase locked values) between couples utilizing previously validated naturalistic interaction paradigms. Specifically during the motor cooperation task, empathy giving task, and affective touch and eye contact paradigm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be based on providing a comprehensive assessment of the effects of LSD on (pro)social cognitive processing. Tasks which have previously shown psychedelic-induced enhancements of (pro)social cognitive behaviours will be utilized, and adapted to be performed between dyads, or expanded on in order to further elucidate the effect of LSD. The tasks will measure: empathy, self-other distinction, altruism, social influence processing, social rejection processing, creativity, sociality, and conflict resolution. Subacute secondary outcomes on (pro)social cognitive processing will determine whether LSD induces changes which outlast the acute stage. Tertiary endpoints will include acute assessment of LSD drug concentrations in blood, and subjective drug effects. Additionally, the influence on socially relevant hormones and cytokines in blood will be assessed. Finally, persisting changes in relationship quality, sexual function, and subsequent personal well-being will be measured. | — |
Countries
Netherlands
Outcome results
None listed