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Could a tiny dose of LSD ease PMS? new study investigates

NCT ID NCT07189299

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether very low doses of LSD (10 micrograms) taken daily or every other day during the premenstrual phase can reduce symptoms of severe PMS or PMDD. 150 women will be randomly assigned to LSD or placebo for three menstrual cycles. The goal is to see if LSD can safely ease mood and physical symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LSD (lysergic acid diethylamide)
What this could lead to
If it works, this could point toward a new way to manage severe PMS or PMDD symptoms using low-dose LSD during the premenstrual phase.
What could go wrong
This is an early-phase study with a small dose and short treatment window. LSD is a controlled substance, and side effects or lack of benefit are possible. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion crtieria: * Between 18-45 years. * Are menstruating and have cycles with a duration between 21 - 35 days. * Meet DSM-V criteria for PMDD or criteria for severe PMS with daily ratings over 2 cycles to confirm luteal symptoms. 1. For PMDD, participants must have a minimal average luteal phase score of mild (≥3 on a 6-point scale) for at least 5 Symptoms on the DRSP including 1 mood symptom during the 5 most symptomatic of the final 7 luteal phase days and the first 2 days of menses onset, and the average follicular phase score must not be \>2 on these same items. 2. For severe PMS, participants must have a minimal average luteal phase score of mild (≥3 on a 6-point scale) for at least 4 Symptoms on the DRSP including 1 mood symptom, during the 5 most symptomatic of the final 7 luteal phase days and the first 2 days of menses onset, and the average follicular phase core must not be \>2 on these same items. * Have reported PMDD/PMS symptoms for the majority of menstrual cycles (\>9 of 12) during the year prior to screening. * Sufficient understanding of the German language * Sufficient understanding of the study procedures and risks associated with the study. * Participants must be willing to adhere to the study procedures and sign the consent form. * Willing not to drive or operate heavy machinery during the acute treatment phases of the study. * Willing to refrain from more than 7 standard alcoholic drinks a week, more than 10 cigarettes a day, and any illicit substances. * Willing to use effective contraceptive measures throughout study participation. Exclusion Criteria: * Known hypersensitivity to LSD * Current treatment for PMS/PMDD * Use of an oral hormonal contraceptive \< 6 months. * Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features. * First degree relative with a psychotic disorder. * Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 symptoms ≥ 6). * Borderline personality disorder. * Current post-traumatic stress disorder. * Pregnant or breastfeeding * Planned pregnancy. * Current or recent history of significant suicide ideation or suicide behavior within the past 6 months. * Current substance use disorder (\< 12 months) other than tobacco smoking. * Other illness that excludes repeated LSD administration or requires interfering medication. * Participation in another clinical trial (currently or within the last 30 days)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Pharmacology & Toxicology, University Hospital Basel

    Basel, Canton of Basel-City, 4056, Switzerland

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