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LSDEarly Phase 1MESA-XNCT07061886

Drug Effects on Mood and Behavior - Expectancy

A Early Phase 1 study testing LSD in people with LSD, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine the effects of a single low dose of the 5HT2A agonist LSD (Lysergic Acid Diethylamide) (13 µg) or placebo in individuals who are or are not explicitly told what drug they will receive. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
LSD
What is being tested?
LSD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteUnited States
Study dates
26 Jun 2025to 5 Jun 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • English Fluency
  • High school education or higher
  • BMI between 19-30 kg/m2

Who cannot join

  • Individuals with a medical condition contraindicating study participation as determined by the study physician (e.g., liver disease, abnormal EKG, liver or cardiovascular disease)
  • High blood pressure (>140/90)
  • Current suicidal ideation or suicide attempt in past 12 months
  • Past year severe substance use disorder
  • Personal or first-degree relative with history of psychosis
  • Currently taking any psychiatric medication (for conventional antidepressants must be off for ≥ 2 weeks)
Show all 10Show fewer
  • Active panic disorder
  • Severe obsessive-compulsive disorder
  • Severe post-traumatic stress disorder
  • Women who are pregnant or planning to become pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

This study will examine the effects of a single low dose of the 5HT2A agonist LSD (Lysergic Acid Diethylamide) (13 µg) or placebo in individuals who are or are not explicitly told what drug they will receive. Although it is known that expectancies strongly influence subjective responses to most drugs, no studies have examined expectancies on response to a very low dose of LSD. This is especially important in the context of 'microdosing' of drugs. People who practice microdosing typically do so with strong expectations of positive effects, making it difficult to determine whether there is a pharmacological effect. To minimize expectancies in the laboratory, participants are usually not told exactly what drug they will receive (i.e., double-blind), but given a range of possibilities. In the present study, the study team will test half the subjects under single-blind conditions, where the participants (but not the research assistant) will know exactly what they are receiving. Other subjects will receive the usual instructions. Healthy volunteers will receive either a marginally detectable dose of LSD (13 micrograms) or placebo, under conditions where they i) know for sure what drug they are receiving or ii) where the identity of the drug is uncertain. Four groups of subjects (N=12 each) will attend single 4-hour laboratory session. The study team will examine subjective and behavioral responses to the drug in each of four conditions (Known-Drug; Known-Placebo; Uncertain-Drug; Uncertain-Placebo).

Read the detailed description

Expectancies are known to influence responses to psychoactive drugs. The study team and others have shown previously, using a balanced placebo design, that expectancies influence responses to alcohol, nicotine, caffeine, stimulant drugs, and cannabinoids. In these studies subjects are randomly assigned to one of four conditions: Expect the drug and get the drug; Expect the drug and get placebo; Expect placebo and get the drug; Expect placebo and get placebo. This allows researchers to separate pharmacological effects from expectancy effects.

Recently there has been much discussion about the role of expectancies specifically in responses to psychedelic drugs. Expectancies are especially important in the use of very low doses, referred to as 'microdoses'. These doses are typically at or below the threshold of detectability, but users take them with strong prior beliefs that the drugs improve mood and cognition. The beneficial effects have been difficult to demonstrate under laboratory conditions, perhaps because in the laboratory the drugs are administered without the explicit expectation of benefits, and the administration of the drugs is to some extent blinded. The present study is designed to separate the pharmacological effects of a low dose of LSD from effects that are influenced by expectancies.

Conditions
LSD
Being tested
LSD, Placebo
Keywords
Healthy Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LSDDrug

    Also called Lysergic acid diethylamide

    The serotonin 2A receptor agonist LSD

  • PlaceboDrug

    Distilled water (0.26 mL)

Study groups in NCT07061886
Study groupRoleWhat they receive
LSD (13 micrograms), Identity of substance knownExperimentalLSD tartrate in tasteless solution (0.13 mL). Subjects will receive LSD, and they (but not the research assistant) will be told the identity of the drug.
Receives: Drug: LSD
LSD (13 micrograms), Identity uncertainActive comparatorLSD tartrate in tasteless solution (0.13 mL). Subjects will be told they might receive a stimulant, sedative, low dose of hallucinogen, or placebo, and will receive LSD.
Receives: Drug: LSD
Placebo, Identity of substance knownPlacebo comparatorDistilled water (0.13 mL). Subjects will receive placebo, and they (but not the research assistant) will be told the identity of the drug.
Receives: Drug: Placebo
Placebo, Identity uncertainPlacebo comparatorDistilled water (0.13 mL). Subjects will be told they might receive a stimulant, sedative, low dose of hallucinogen, or placebo, and will receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale (VAS)

    Momentary states will be assessed using VAS to measure ratings of 'depressed', 'anxious', 'motivated', and 'energetic', on a scale of 0 (Not at all) to 100 (Very much).

    Measured: During in-lab session: Pre-drug, and every 60 minutes post-drug from 0-4 hours

  2. Addiction Research Center Inventory (ARCI)

    The ARCI is a 53-item true or false questionnaire that assess effects of specific drug classes. It includes scales measuring: amphetamine (A); benzedrine group (BG; energy and intellectual efficiency); morphine-benzedrine group (MBG; euphoric effects); LSD (hallucinogen-like effects); pentobarbital-chlorpromazine-alcohol group (PCAG; sedative effects); and marijuana (M).

    Measured: During in-lab session: Pre-drug, and every 60 minutes post-drug from 0-4 hours

  3. Drug Effects Questionnaire (DEQ)

    The DEQ measures overall drug effects. It consists of questions on a visual analog scale about the subjective effects of drugs. Subjects are asked to rate the extent they feel a drug effect, whether they like or dislike the drug effect, and if given a choice would they want to take more of the drug. Scores range from 0-100.

    Measured: During in-lab session: Pre-drug, and every 60 minutes post-drug from 0-4 hours

  4. 5 Dimensions of Altered States of Consciousness (5D-ASC) scale

    The 5D-ASC assesses altered states of consciousness in five domains, and is sensitive to LSD administration (Schmid et al. 2014). Scores range from 0-100.

    Measured: End of session (4 hours post-drug)

  5. Ultimatum Game

    In this task, participants play the role of responder in a series of single-shot computer interactions. They engage in 60 trials in which they interact with different computer-simulated proposers. On each trial they are allocated $10 to split between themselves and the participant. Participants will receive 60 different monetary offers ranging from fair (50:50 splits) to increasingly unfair (10:90 splits), presented in random order. For each offer, participants must decide whether to accept the offer, in which case both players receive the proposed amounts, or reject the offer, in which case both players receive nothing. This task will measure how the drug affects perception of fairness, and decision-making in social contexts. The task takes approximately a 30 minutes to complete.

    Measured: During in lab session: 1.5 hours post-drug

Secondary outcomes (2)
  1. Cardiovascular (Heart rate; beats per minute)

    heart rate (HR) will be measured using a portable digital blood pressure monitor.

    Measured: During in-lab session: baseline (pre-drug), and every 60 minutes post-drug from 0-4 hours

  2. Cardiovascular (blood pressure; mmHg)

    Systolic pressure (SP), and diastolic pressure (DP) will be measured using a portable digital blood pressure monitor.

    Measured: During in-lab session: baseline (pre-drug), and every 60 minutes post-drug from 0-4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start26 Jun 2025
  3. Primary completion5 Jun 2026
  4. Study completion5 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07061886
Sponsor's protocol ID
IRB25-0658
Other IDs
5R01DA002812-35
Acronym
MESA-X
Status last verified
Jul 2026
First submitted
6 Jun 2025
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Aron, A., Melinat, E., Aron, E. N., Vallone, R. D., & Bator, R. J. (1997). The Experimental Generation of Interpersonal Closeness: A Procedure and Some Preliminary Findings. Personality and Social Psychology Bulletin, 23(4), 363-377. https://doi.org/10.1177/0146167297234003

  • Beck, A. T., Steer, R. A., & Brown, G. (1996). Beck Depression Inventory-II (BDI-II). In APA PsycTests

  • Bershad AK, Schepers ST, Bremmer MP, Lee R, de Wit H. Acute Subjective and Behavioral Effects of Microdoses of Lysergic Acid Diethylamide in Healthy Human Volunteers. Biol Psychiatry. 2019 Nov 15;86(10):792-800. doi: 10.1016/j.biopsych.2019.05.019. Epub 2019 Jun 3.

    PubMed 31331617
  • de Wit H, Molla HM, Bershad A, Bremmer M, Lee R. Repeated low doses of LSD in healthy adults: A placebo-controlled, dose-response study. Addict Biol. 2022 Mar;27(2):e13143. doi: 10.1111/adb.13143. Epub 2022 Feb 1.

    PubMed 35106880
  • Dittrich A. The standardized psychometric assessment of altered states of consciousness (ASCs) in humans. Pharmacopsychiatry. 1998 Jul;31 Suppl 2:80-4. doi: 10.1055/s-2007-979351.

    PubMed 9754838
  • Fadiman, J and Gruber, J (2025) Microdosing for Health, Healing, and Enhanced Performance, St Martins Group

  • Fischman MW, Foltin RW. Utility of subjective-effects measurements in assessing abuse liability of drugs in humans. Br J Addict. 1991 Dec;86(12):1563-70. doi: 10.1111/j.1360-0443.1991.tb01749.x.

    PubMed 1786488
  • Güth, W, RSchmittberger, B Schwarze (1982) An experimental analysis of ultimatum bargaining. Journal of Economic Behavior & Organization, Volume 3, 367-388

  • Hammami MM, Al-Gaai EA, Alvi S, Hammami MB. Interaction between drug and placebo effects: a cross-over balanced placebo design trial. Trials. 2010 Nov 19;11:110. doi: 10.1186/1745-6215-11-110.

    PubMed 21092089
  • Lyvers MF, Maltzman I. The balanced placebo design: effects of alcohol and beverage instructions cannot be independently assessed. Int J Addict. 1991 Sep;26(9):963-72. doi: 10.3109/10826089109058933.

    PubMed 1743824
  • Martin WR, Sloan JW, Sapira JD, Jasinski DR. Physiologic, subjective, and behavioral effects of amphetamine, methamphetamine, ephedrine, phenmetrazine, and methylphenidate in man. Clin Pharmacol Ther. 1971 Mar-Apr;12(2):245-58. doi: 10.1002/cpt1971122part1245. No abstract available.

    PubMed 5554941
  • McNair, D., Lorr, M., Droppleman, L., (1971). POMS, Profile of Mood States. E. a. I. T. Services.

  • Metrik J, Kahler CW, Reynolds B, McGeary JE, Monti PM, Haney M, de Wit H, Rohsenow DJ. Balanced placebo design with marijuana: pharmacological and expectancy effects on impulsivity and risk taking. Psychopharmacology (Berl). 2012 Oct;223(4):489-99. doi: 10.1007/s00213-012-2740-y. Epub 2012 May 16.

    PubMed 22588253
  • Molla H, Lee R, Tare I, de Wit H. Greater subjective effects of a low dose of LSD in participants with depressed mood. Neuropsychopharmacology. 2024 Apr;49(5):774-781. doi: 10.1038/s41386-023-01772-4. Epub 2023 Dec 2.

    PubMed 38042914
  • Murphy RJ, Muthukumaraswamy S, de Wit H. Microdosing Psychedelics: Current Evidence From Controlled Studies. Biol Psychiatry Cogn Neurosci Neuroimaging. 2024 May;9(5):500-511. doi: 10.1016/j.bpsc.2024.01.002. Epub 2024 Jan 26.

    PubMed 38280630

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LSD in people with LSD, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: During in-lab session: Pre-drug, and every 60 minutes post-drug from 0-4 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07061886, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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