Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only, etc.

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date;

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected]
Informed consent form  [email protected]


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes March 28th 2023. Acute mood-elevating properties o... [More Details]

Documents added automatically
No additional documents have been identified.