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

Plain-language summary

This study examined how the drug Paroxetine (a medication that inhibits the serotonin transporter, SERT) changes the subjective effects produced by LSD in healthy volunteers. It enrolled healthy adult volunteers who met certain health and body-mass index criteria. The study was carried out in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

University Hospital, Basel, Switzerland

Intervention

Paroxetine, Lysergic Acid Diethylamide, Placebo

Start date

10/24/2022

Estimated completion

3/7/2024

Countries

Switzerland

Related genes

Locations

• Basel, Switzerland

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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).