CompletedPhase 1LSD

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

Sponsored by University Hospital, Basel, Switzerland

NCT ID
NCT05175430
Target Enrollment
24 participants
Start Date
2022-10-24
Est. Completion
2024-03-07

About This Study

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.

Conditions Studied

Healthy

Interventions

  • Paroxetine
  • Lysergic Acid Diethylamide
  • Placebo

Eligibility

Age:25 Years - 65 Years
Healthy Volunteers:Yes
View full eligibility criteria
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).

Study Locations (1)

Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, Switzerland

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

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