None listed
Conditions
Brief summary
“Microdosing” refers to repeated administration of psychedelics such as LSD or psilocybin in doses below the threshold for overtly altering perception. There is a growing microdosing subculture and grey literature suggesting that this practice can enhance creativity and productivity, improve mood and favourably modify personality traits. These claimed effects are similar to those observed in clinical studies, in which participants receive much larger, perception-altering doses of LSD or psilocybin. However, there are as yet no controlled, scientific studies of the psychological or physiological effects of repeated psychedelic home-self-administered microdosing. Given the powerful nature of placebo and expectancy effects on self-reports, controlled trials are required to objectively evaluate the effects of microdoses of psychedelic drugs in humans. In this study, we will conduct a randomised controlled trial of repeated microdoses of LSD under schedules similar to those suggested in the grey literature. 80 healthy volunteers will be randomised to receive repeated doses of either inactive placebo or LSD (10 µg oral) under double-blind conditions in a parallel groups design. A variety of physiological and psychological measures will be recorded at baseline and after completion of each of a six-week dosing regimen. Measures will include a validated personality scale and tests of creativity. Electroencephalography will be used to directly measure brain function in each participant before and after treatment. Our results will enable a rigorous evaluation of the purported benefits of psychedelic microdosing and will be relevant to the question of whether microdosing may be a viable alternative treatment regimen for depression, where full psychedelic doses are currently being investigated in clinical trials.
Interventions
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 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.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
• Participant is willing and able to give informed consent for participation in the trial. • Males aged 25-60 years inclusive.
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
Outcome results
None listed