Microdosing LSD in Women With Premenstrual Disorders

NCT07189299 | Not Yet Recruiting

• 1 other identifier: BASEC 2025-00745
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to investigate the role of the serotonin 2A receptor in women with premenstrual disorders. This study uses a double-blind, randomized, controlled design with 3 arms: Intervention 1: 10 micg LSD for \~10 days during the late luteal phase (for 3 cycles) Intervention 2: 10 micg LSD every other day for \~10 days during the late luteal phase (for 3 cycles) Control intervention: Placebo for \~10 days during the late luteal phase (for 3 cycles) Each participant will be treated in only one arm. The study employs a parallel design with three treatment arms and consists of a two-cycle observational phase followed by a three-cycle treatment phase.

Conditions

PMS; PMDD

Keywords

Hallucinogens; Serotonin Agents; LSD; Premenstrual disorders; Premenstrual syndrome; Psychotropic drugs; Microdose; Serotonin system; Psychedelics

Outcome Measures

Primary Outcomes (1)

• Change in premenstrual symptom burden

  Premenstrual symptom burden measured with the Daily Record of Severity of Problems (DRSP) total score as the mean of the 5 highest symptomatic days of the 7 days before menstruation onset as mean change from baseline (the two monitored cycles before treatment start) of symptoms over all three treatment periods compared with the other study arms.

  Daily over the 5 cycle study course (average cycle duration is 28 days)

Secondary Outcomes (20)

• Montgomery-Asberg-Depression-Rating Scale (MARDS)

  Ratings will be performed on day 3 of each menstural cycle, over the whole study period of 5 menstrual cycles, to retrospectively rate depressive symptoms during the premenstrual phase (based on an average cycle duration of 28 days)

• Hamilton Anxiety Rating Scale (HAM-A)

  Ratings will be performed on day 3 of each menstural cycle , over the whole study period of 5 menstrual cycles to retrospectively rate anxiety symptoms during the premenstrual phase ((based on an average cycle duration of 28 days).

• State-trait anxiety inventory (STAI)

  The STAI will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of mensturation) over the whole study period of 5 menstrual cycles.

• Beck Depression Inventory (BDI)

  The BDI will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of mensturation) over the whole study period of 5 menstrual cycles.

• Quality of Life (WHOQOL-bref)

  The WHOQOL-bref will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of me, additionally it will be assessed at screening and once during the luteal phase

Study Arms (3)

10 μg LSD every day during the acute symptom phase

EXPERIMENTAL

Participants receive 10 μg LSD daily, starting at symptom onset (or latest 7 days after ovulation) until day 3 of the following cycle for 3 menstrual cycles

Drug: LSD 10 μg every Day

10 μg LSD every second day during acute symptom phase

EXPERIMENTAL

10 μg LSD every second day during acute symptom phase starting at symptom onset (or 7 days after ovulation) until day 3 of the following cycle for 3 menstrual cycles

Drug: LSD 10 μg every other day

Placebo Control

PLACEBO COMPARATOR

The subjects in the control arm will receive oral placebo over 3 cycles during the luteal phase, starting at symptom onset (or latest 7 days after ovulation) until day 3 of the following cycle.

Drug: Placebo

Interventions

LSD 10 μg every Day DRUG

Participants will receive 10 μg LSD every day during the luteal phase

10 μg LSD every day during the acute symptom phase

LSD 10 μg every other day DRUG

Participants receive 10μg LSD every second day during the luteal phase

10 μg LSD every second day during acute symptom phase

Placebo DRUG

Participants receive inactive placebo during the luteal phase

Placebo Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Friederike Holze: lead

Study Sites (1)

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, Canton of Basel-City, 4056, Switzerland

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Lysergic Acid Diethylamide

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Friederike Holze, Dr.

CONTACT

+41613287735; friederike.holze@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinical Research

Model Details: This study uses a randomized, double-blind, placebo-controlled, parallel design with 3 intervention arms. Participants will be allocated in a 1:1:1 ratio to one arm.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 23, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)