Mood Effects of Serotonin Agonists Extended (MESA-E)

November 28, 2023 updated by: University of Chicago
In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Here, we are examining the effects of four repeated low doses of lysergic acid diethylamide (LSD), compared to placebo, administered to healthy adults at 3-4 day intervals, on mood, cognitive performance and responses to emotional tasks

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Matthew Bona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English fluency
  • High school level education
  • BMI between 19 and 30

Exclusion Criteria:

  • Diagnosed medical condition
  • women who are nursing, pregnant, or plan to become pregnant within 3 months
  • History of psychotic disorder or family history of psychotic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Drug will be administered in solution form
Experimental: Serotonin agonist 13ug
13ug of serotonin agonist
Drug: Serotonin agonist - 13ug
13ug lysergic acid diethylamide
Other Names:
  • LSD
Experimental: Serotonin agonist 26ug
26ug of serotonin agonist
Drug: Serotonin agonist - 26ug
26ug lysergic acid diethylamide
Other Names:
  • LSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASS-21
Time Frame: End of session 5, approximately 2 weeks from baseline
The primary outcome measure is the depression anxiety and stress scale (DASS) 21. This self-report measure contains 21 items and the range of scores for depression is 0-42, anxiety 0-42, and stress 0-42. Our primary outcome measure is total depression scale ratings during session 5, with lower scores indicating lower ratings of depression.
End of session 5, approximately 2 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Harriet de Wit, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2019

Primary Completion (Actual)

June 7, 2021

Study Completion (Actual)

June 7, 2021

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-1183
  • 5R01DA002812 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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