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Trial registered on ANZCTR


Registration number
ACTRN12624000668505
Ethics application status
Approved
Date submitted
13/05/2024
Date registered
27/05/2024
Date last updated
27/05/2024
Date data sharing statement initially provided
27/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the menstrual cycle on Lysergic acid diethylamide (LSD)
Scientific title
An open-label trial to test menstrual cycle effects and tolerance to LSD microdosing in healthy menstruating persons (MDMENS).
Secondary ID [1] 312134 0
None
Universal Trial Number (UTN)
Trial acronym
MDMENS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual cycle 333784 0
Condition category
Condition code
Reproductive Health and Childbirth 330453 330453 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sublingually administered Lysergic acid diethylamide (LSD) solution.

20 mcg of the MB-22001 formulation in the "Laboratory Dosing period". Adherence is monitored in person in this period. One dose administered in each of the ovulatory and luteal phases and three doses administered one day apart in the follicular phase

5-20 mcg of the MB-22001 formulation in the "Home Dosing period". Starting dose is 8 mcg. Dose increased/decreased by 1 or 2 mcg at each dose if well tolerated at participant discretion. For adherence participants complete a customised questionnaire confirming dose has been taken. 5 doses administered in the follicular phase and 6 doses in the luteal phase. All doses separated by at least one day
Intervention code [1] 328569 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338216 0
Measure of menstrual-cycle related mood issues assessed as a composite outcome
Timepoint [1] 338216 0
The evening of each intervention in both the "Laboratory Dosing period" and "Home Dosing period"
Primary outcome [2] 338217 0
Psychoactive drug effects
Timepoint [2] 338217 0
The evening of each intervention in Bothe the "Laboratory Dosing" and "Home Dosing" periods
Secondary outcome [1] 435011 0
Brain activity with eyes closed
Timepoint [1] 435011 0
Recorded approximately 2 hours after each intervention (Laboratory Dosing period only)
Secondary outcome [2] 435014 0
Drug concentration
Timepoint [2] 435014 0
Blood samples collected at 0,20,40,60,90, 120,180, 240,360 minutes relative to dose administration in the Laboratory Dosing period
Secondary outcome [3] 435265 0
Brain activity with eyes open
Timepoint [3] 435265 0
Recorded approximately 2 hours after each intervention (Laboratory period only)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
46 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sequential visits. Visits in each of the follicular, ovulatory and luteal phases during both Baseline and Laboratory Dosing periods
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26301 0
New Zealand
State/province [1] 26301 0

Funding & Sponsors
Funding source category [1] 316494 0
University
Name [1] 316494 0
The University of Auckland
Country [1] 316494 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318668 0
None
Name [1] 318668 0
None
Address [1] 318668 0
Country [1] 318668 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315288 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315288 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 315288 0
New Zealand
Date submitted for ethics approval [1] 315288 0
01/12/2023
Approval date [1] 315288 0
20/02/2024
Ethics approval number [1] 315288 0
2024 FULL 19211

Summary
Brief summary
The menstrual cycle causes major fluctuations in hormones. Changes to progesterone and estrogen in particular are known to dramatically affect not just reproductive systems but brain function. Females are majorly overrepresented in adverse reactions to common medications which suggests that menstrual cycle linked hormones may not just change disorder symptoms but also the response to drug therapies. We will study how the brain’s response to a drug changes over the menstrual cycle. In this study we will examine how the menstrual cycle may change how females are affected by the drug LSD. We will study this by taking blood samples and using standardised questionnaires. We will test the hypotheses that the pharmacokinetics and pharmacodynamics of LSD are modified across the menstrual cycle. This research may help to improve treatments by taking the menstrual cycle into account and potentially reduce symptoms and adverse reactions over the menstrual cycle.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134234 0
A/Prof Suresh Muthukumaraswamy
Address 134234 0
Faculty of Medical and Health Sciences, The University of Auckland. 85 Park Rd, Grafton, Auckland, 1023
Country 134234 0
New Zealand
Phone 134234 0
+64 09 9232787
Fax 134234 0
Email 134234 0
sd.muthu@auckland.ac.nz
Contact person for public queries
Name 134235 0
Suresh Muthukumaraswamy
Address 134235 0
Faculty of Medical and Health Sciences, The University of Auckland. 85 Park Rd, Grafton, Auckland, 1023
Country 134235 0
New Zealand
Phone 134235 0
+64 09 9232787
Fax 134235 0
Email 134235 0
sd.muthu@auckland.ac.nz
Contact person for scientific queries
Name 134236 0
Suresh Muthukumaraswamy
Address 134236 0
Faculty of Medical and Health Sciences, The University of Auckland. 85 Park Rd, Grafton, Auckland, 1023
Country 134236 0
New Zealand
Phone 134236 0
+64 09 9232787
Fax 134236 0
Email 134236 0
sd.muthu@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.