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Clinical Trials/ACTRN12624000668505
ACTRN12624000668505Not yet recruitingPhase 1

An open-label trial to test menstrual cycle effects and tolerance to LSD microdosing in healthy menstruating persons (MDMENS).

The University of Auckland0 sites20 target enrollmentStarted: May 27, 2024Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Enrollment
20
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 46 Years (—)
Sex
Female

Inclusion Criteria

  • •1.Provision of signed and dated informed consent form.
  • •2.Stated willingness to comply with all study procedures and availability for the duration of the study.
  • •3.Aged, 18-46 years.
  • •4.For heterosexually active persons of child-bearing potential: agree to use non-hormonal contraception during the Laboratory and Home Dosing periods.
  • •5.To have regular menstrual cycles

Exclusion Criteria

  • •1.Any item 1-13 of the Premenstrual Symptoms Screening Tool scoring above mild” and any item A-E scoring above mild.
  • •2.Any psychiatric diagnosis flagged by Clinical Interview
  • •3.Confirmed first degree relative with schizophrenia or other psychotic disorder, or bipolar I or II disorder.
  • •4.Risk of suicide as determined by The Columbia-Suicide Severity Rating Scale (C-SSRS).
  • •5.Substance dependence in the previous 6 months as assessed by clinical interview with a New Zealand modified version of the NIDA (National Institute of Drug Abuse) Modified Alcohol, Smoking and Substance. Involvement Screening Test NM-ASSIST.
  • •6.Problematic use of alcohol defined as a score on the Alcohol Use Disorders Identification Test (AUDIT) of 16 or greater.
  • •7.Body mass index (BMI) <18 and > 35.
  • •8.Planned or current pregnancy or lactation.
  • •9.Cardiovascular conditions including abnormal heart rate or blood pressure to be checked at screening. A threshold of exceeding 160 mmHg (systolic) and 90 mmHg (diastolic), averaged across three assessments taken on the screening day will be used. Participants with well-managed hypertension would not be excluded.
  • •10.Significant renal or hepatic impairment.
  • •11.Diagnosed or probable polycystic ovary syndrome (PCOS)
  • •12.Abnormal 12-lead Electrocardiogram (ECG) as judged by a study physician.
  • •13.Abnormal laboratory test findings as judged by a study physician.
  • •14.Any unstable medical or neurological condition.
  • •15.Regular use of any Central Nervous System (CNS) active medications in the last three months
  • •16.Use of hormonal contraceptives/steroid hormones in the last three months
  • •17.Regular use of any medication/supplements deemed to be contraindicating as judged by a study physician.
  • •18.Treatment with another investigational drug or other intervention within 2 months.
  • •19.Any lifetime history of psychedelic microdosing.
  • •20.Use of serotonergic psychedelic drugs (LSD, psilocybin, Dimethyltryptamine (DMT) etc.) in the last year.
  • •21.Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.

Investigators

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