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CompletedPhase 1

Effects of SERT Inhibition on the Subjective Response to LSD in Healthy Subjects

NCT05175430 · SERT-LSD · University Hospital, Basel, Switzerland

Closed to entry
Status
Not accepting participants
Phase 1
Phase
24
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Lysergic acid diethylamide (LSD) is a classic serotonergic psychedelic acting on the serotonin 5-HT2A receptor. LSD is used recreationally and in psychiatric research. First studies suggest efficacy in psychiatric disorders, such as depression and anxiety. SSRIs like paroxetine are first-line treatments for depression and anxiety disorders. Paroxetine acts as a serotonin transporter (SERT) inhibitor. However, the link between this mechanism and its positive effects on mood remains to be established. Several studies suggest a possible downregulation of postsynaptic serotonin (5-HT) receptors such as the 5-HT2A receptor. The aim of the study is to assess whether SERT inhibition reduces expression of the gene coding for the 5-HT2A receptor and the response to LSD.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • 5 dimensions of altered state of consciousness (5D-ASC) total OAV score

    Measured over Study sessions per participant will be separated by at least 43 days

  • Visual Analog Scales (VAS) good effect rating

    Measured over Study sessions per participant will be separated by at least 43 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Understanding of the German language. * Understanding the procedures and the risks that are associated with the study. * Participants must be willing to adhere to the protocol and sign the consent form. * Participants must be willing to refrain from taking illicit psychoactive substances during the study. * Participants must be willing to abstain from xanthine-based liquids from the evenings prior to the study sessions and during the sessions. * Participants must be willing not to drive a traffic vehicle or to operate machines within 48h after substance administration. * Willing to use double-barrier birth control throughout study participation. * Body mass index between 18-29 kg/m2. Exclusion Criteria: * Chronic or acute medical condition, including a history of seizures. * Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders). * Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain. * Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg); QT-time\>450 ms (men) or \>470 ms (women). * Use of hallucinogenic substances (not including cannabis) more than 20 times or any time within the previous two months. * History of acute glaucoma. * Pregnant or nursing women. * Participation in another clinical trial (currently or within the last 30 days). * Use of medications that may interfere with the effects of the study medications (any psychiatric medications and any medication with known pharmacokinetic or pharmacodynamic interactions with paroxetine). * Tobacco smoking (\>10 cigarettes/day). * Consumption of alcoholic drinks (\>20 drinks/week).

Where

1 study site

FacilityCityRegionCountry
Clinical Pharmacology & Toxicology, University Hospital BaselBaselSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05175430 on ClinicalTrials.gov →

Last updated in the registry 2024-03-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits