Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000436875
Ethics application status
Approved
Date submitted
19/02/2021
Date registered
16/04/2021
Date last updated
3/04/2023
Date data sharing statement initially provided
16/04/2021
Date results provided
3/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled trial of repeated microdoses of lysergic acid diethylamide (LSD) in healthy volunteers
Scientific title
A randomised, double-blind, placebo-controlled trial to study the effects of repeated microdoses of lysergic acid diethylamide (LSD) on creativity and brain activity in healthy adult males.
Secondary ID [1] 303516 0
Nil
Universal Trial Number (UTN)
U1111-1221-5135
Trial acronym
MDLSD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 320837 0
Condition category
Condition code
Mental Health 318662 318662 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 mcg Lysergic acid diethylamide (LSD)
Dissolved in water in 1 ml oral syringes.
One dose taken every three days. Repeated 14 times for a 41 day regimen.
Adherence will be monitored by participants sending video recordings of each dose administration to the study team

Mid Study Amendment: Participants are offered entry into a titration protocol if the received dose is not being well tolerated.The titration protocol is started at 5 mcg and increased at +1 mcg per dose until either a maximum of 10 mcg is reached or less if that is the maximum dose acceptably tolerated by that participant.

Mid Study Amendment 2: In the event that a participant has to self-isolate due to the pandemic, as an alternative to withdrawal, the treatment regimen may be paused for up to ten days for that participant.
Intervention code [1] 319799 0
Treatment: Drugs
Comparator / control treatment
Water in 1 ml oral syringes
One dose taken every three days. Repeated 14 times for a 41 day regimen.
Adherence will be monitored by participants sending video recordings of each dose administration to the study team
Control group
Placebo

Outcomes
Primary outcome [1] 326607 0
Creative thinking as assessed with the Alternate Uses Test
Timepoint [1] 326607 0
Baseline, Day 1 (3 hours post first administration) and Day 43 (2 days after last administration)
Primary outcome [2] 326608 0
Open-mindedness as assessed with the Big Five Inventory-2 (Openness subscale)
Timepoint [2] 326608 0
Baseline and Day 43 (2 days after last administration)
Primary outcome [3] 326609 0
Convergent thinking as assessed with the Remote Associates Task
Timepoint [3] 326609 0
Baseline, Day 1 (3 hours post first administration) and Day 43 (2 days after last administration)
Secondary outcome [1] 392100 0
EEG - mismatch negativity
Timepoint [1] 392100 0
Baseline, Day 1 (2 hours post first administration) and Day 43 (2 days after last administration)
Secondary outcome [2] 392101 0
EEG - long-term potentiation
Timepoint [2] 392101 0
Baseline, Day 1 (2 hours post first administration) and Day 43 (2 days after last administration)
Secondary outcome [3] 392102 0
Openness to experience as assessed with the Modified Tellegen Absorption Scale
Timepoint [3] 392102 0
Baseline and Day 43 (2 days after last administration)
Secondary outcome [4] 392103 0
Creativity as assessed with the Consensual Assessment Technique
Timepoint [4] 392103 0
Baseline, Day 1 (3 hours post first administration) and Day 43 (2 days after last administration)
Secondary outcome [5] 392104 0
Daily mood questionnaire. VAS scales completed on mobile phone.
Timepoint [5] 392104 0
Day 1 through 43 (2 days after last administration)
Secondary outcome [6] 392105 0
Concentration of LSD in blood plasma
Timepoint [6] 392105 0
Day 1 of regimen
Secondary outcome [7] 392106 0
Profile of Mood States
Timepoint [7] 392106 0
Day 1 of regimen
Secondary outcome [8] 392107 0
Heart rate measured with blood pressure monitor
Timepoint [8] 392107 0
Baseline, Day 1 and Day 43 (2 days after last administration)
Secondary outcome [9] 392108 0
Blood pressure measured with blood pressure monitor
Timepoint [9] 392108 0
Baseline, Day 1 and Day 43 (2 days after last administration)
Secondary outcome [10] 393046 0
Depression as measured with the DASS42
Timepoint [10] 393046 0
Baseline and Day 43 (2 days after last administration)
Secondary outcome [11] 393047 0
Acute drug effects as measured with Visial Analog Scales
Timepoint [11] 393047 0
Day 1
Secondary outcome [12] 394133 0
Stress as measured with the DASS42
Timepoint [12] 394133 0
Baseline and Day 43 (2 days after last administration)
Secondary outcome [13] 394134 0
Anxiety as measured with the DASS42
Timepoint [13] 394134 0
Baseline and Day 43 (2 days after last administration)

Eligibility
Key inclusion criteria
• Participant is willing and able to give informed consent for participation in the trial.
• Males aged 25-60 years inclusive.
Minimum age
25 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Current use of any prescribed psychotropic medication.
• Significant renal or hepatic impairment as judged by study clinicians.
• 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 four assessments taken on the screening day will be used.
• Any unstable medical or neurologic condition.
• Current or past history schizophrenia or other psychotic disorders, or bipolar I or II disorder as assessed by the Standard MINI
• Imminent risk of suicide as determined by The Columbia-Suicide Severity Rating Scale (C-SSRS).
• Lifetime presence of major depressive disorder as assessed by the MINI.
• Current diagnosis of PTSD, anxiety and panic disorders, OCD, dysthymic disorder, anorexia, and bulimia
• Body-weight <50kg or > 120kg
• Substance dependence in the previous 3 months as assessed with a New Zealand modified version of the NM-ASSIST

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2021
Actual
19/04/2021
Date of last participant enrolment
Anticipated
16/04/2022
Actual
1/03/2022
Date of last data collection
Anticipated
Actual
26/04/2022
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 23481 0
New Zealand
State/province [1] 23481 0

Funding & Sponsors
Funding source category [1] 307929 0
Government body
Name [1] 307929 0
Health Research Council of New Zealand
Country [1] 307929 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 308654 0
None
Name [1] 308654 0
Address [1] 308654 0
Country [1] 308654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307930 0
HDEC Southern
Ethics committee address [1] 307930 0
Ethics committee country [1] 307930 0
New Zealand
Date submitted for ethics approval [1] 307930 0
Approval date [1] 307930 0
19/11/2019
Ethics approval number [1] 307930 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108962 0
A/Prof Suresh Muthukumaraswamy
Address 108962 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 108962 0
New Zealand
Phone 108962 0
+64 09 3737599
Fax 108962 0
Email 108962 0
[email protected]
Contact person for public queries
Name 108963 0
Suresh Muthukumaraswamy
Address 108963 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 108963 0
New Zealand
Phone 108963 0
+64 09 3737599
Fax 108963 0
Email 108963 0
[email protected]
Contact person for scientific queries
Name 108964 0
Suresh Muthukumaraswamy
Address 108964 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 108964 0
New Zealand
Phone 108964 0
+64 09 3737599
Fax 108964 0
Email 108964 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, etc.
When will data be available (start and end dates)?
Immediately following publication, no end date;
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10762Study protocol  [email protected]
10763Informed consent form  [email protected]



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.