The effect of the menstrual cycle on Lysergic acid diethylamide (LSD)

Phase 1

• Conditions: Menstrual cycle; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12624000668505
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-27
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified