Prosocial BehaviorPhase 1/2NCT05670184
The Effect of LSD on Neural Synchrony, Prosocial Behavior, and Relationship Quality
A Phase 1/2 study testing LSD and Ethanol in people with Prosocial Behavior, run by Maastricht University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosocial Behavior
- What is being tested?
- LSD and Ethanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2023to 1 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht
Natasha Mason, PhD, natasha.mason@maastrichtuniversity.nl
About this study
The goal of this study is to assess the effects of LSD on neural synchrony, prosocial behavior, and relationship quality in healthy romantic couples.
Read the detailed description
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
- Prosocial Behavior
- Being tested
- LSD, Ethanol
- Medical subject headings
- Altruism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSDDrug
Also called lysergic acid diethylamide
Single dose of LSD (50 µg) will be administered in a small amount of alcohol (ethanol, 2ml/95% Vol.) orally.
EthanolDrug
Identical ampules containing pure ethanol without the investigational product will be used (1mL ethanol, 95% Vol.).
| Study group | Role | What they receive |
|---|---|---|
| LSD condition | Experimental | 60 participants will receive LSD. Receives: Drug: LSD |
| Ethanol condition | Placebo comparator | 60 participants will receive placebo. Receives: Drug: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the acute dosing test day, 1.5-2 hours after substance administration
Secondary outcomes (8)
Empathy
Cognitive and emotional empathy will be assessed via the empathy giving task (EGT) and the multifaceted empathy test (MET).
Measured: On the acute dosing test day, 2 hours (EGT) and 3 hours (MET) after substance administration
Self-other distinction
The degree of self-other merging will be assessed using synchronous multisensory stimulation (SMS), and responses on the inclusion of other in the self scale (OIS).
Measured: 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
Prosocial behavior will be assessed via participants' response rate on the prosocial learning task (PLT), and the amount of effort for other individual in the prosocial effort task (PET).
Measured: On the acute dosing day, 6 hours after substance administration. The PET will also be administered at 2 days follow-up.
Social influence processing
Social influence processing will be assessed via participants' degree of rating adjustment after feedback in the social influence paradigm (SIP).
Measured: On the acute dosing day, 3 hours after substance administration
Trust
The trust game for couples (TGC) will assess participants' willingness to invest personal resources in pro-relationship attitudes.
Measured: On the acute dosing day, 6.5 hours after substance administration
Creativity
Creativity will be assessed by the semantic distance in the chain free association (CFO) and the divergent association tasks (DAT), and also by the ability to separate old and new information in the pattern separation task (PST).
Measured: On the acute dosing day, 5.5 hours (CFO, PST) after substance administration. The DAT will be administered at 2 days follow-up.
Sociality
Sociality will be measured by the social reward questionnaire (SRQ) and the visual analogue scales that measure feelings of social behavior (VAS-S).
Measured: On the acute dosing day, SRQ will be administered at 4.5 hours after substance administration, while the VAS-S will be administered at baseline (-0.5 hours), at 1, 2, 3, 4, 5, 6, and 7 hours after substance administration.
Conflict resolution
The couples conflict resolution (CR) task will measure the duration of positive and negative behavior of members of a couple via video recordings of couples' interactions.
Measured: At 2 days follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosocial BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes G Ramaekers, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670184
- Sponsor's protocol ID
- NL80435.068.22
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of LSD on Neural Synchrony, Prosocial Behavior, and Relationship Quality
- ClinicalTrials.gov ID
- NCT05670184
- Acronym / sponsor ID
- NL80435.068.22
- Conditions
- Prosocial Behavior
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the effects of LSD on neural synchrony, prosocial behavior, and relationship quality in healthy romantic couples.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LSD condition | Experimental | Drug: LSD60 participants will receive LSD. |
| Ethanol condition | Placebo comparator | Drug: Ethanol60 participants will receive placebo. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSDAlso: lysergic acid diethylamideSingle dose of LSD (50 µg) will be administered in a small amount of alcohol (ethanol, 2ml/95% Vol.) orally. | Drug | LSD condition |
| EthanolIdentical ampules containing pure ethanol without the investigational product will be used (1mL ethanol, 95% Vol.). | Drug | Ethanol condition |
Primary outcome
Neural synchrony
Time frame: On the acute dosing test day, 1.5-2 hours after substance administration
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.
8 secondary outcomes
Empathy
Time frame: On the acute dosing test day, 2 hours (EGT) and 3 hours (MET) after substance administration
Self-other distinction
Time frame: 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
Time frame: On the acute dosing day, 6 hours after substance administration. The PET will also be administered at 2 days follow-up.
Social influence processing
Time frame: On the acute dosing day, 3 hours after substance administration
Trust
Time frame: On the acute dosing day, 6.5 hours after substance administration
Creativity
Time frame: On the acute dosing day, 5.5 hours (CFO, PST) after substance administration. The DAT will be administered at 2 days follow-up.
Sociality
Time frame: On the acute dosing day, SRQ will be administered at 4.5 hours after substance administration, while the VAS-S will be administered at baseline (-0.5 hours), at 1, 2, 3, 4, 5, 6, and 7 hours after substance administration.
Conflict resolution
Time frame: At 2 days follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes G Ramaekers, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LSD and Ethanol in people with Prosocial Behavior, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasha Mason, PhD (+31 43 3881382, natasha.mason@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural synchrony (time frame: On the acute dosing test day, 1.5-2 hours after substance administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.