A Phase 1 interventional study of Placebo and Serotonin agonist - 13ug in Healthy, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University of Chicago · Phase 1, Interventional, and Basic science
In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.
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
University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo
Drug: Placebo
13ug of serotonin agonist
Drug: Serotonin agonist - 13ug
26ug of serotonin agonist
Drug: Serotonin agonist - 26ug
Drug will be administered in solution form
13ug lysergic acid diethylamide
Also known as: LSD
26ug lysergic acid diethylamide
Also known as: LSD
DASS-21
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.
Time frame: End of session 5, approximately 2 weeks from baseline
| Milestone | Placebo | Serotonin Agonist | Serotonin Agonist |
|---|---|---|---|
| Started | 18 | 19 | 19 |
| Completed | 18 | 19 | 19 |
| Not completed | 0 | 0 | 0 |
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.
| units on a scale | Placebo | Serotonin Agonist 13ug | Serotonin Agonist 26ug |
|---|---|---|---|
| DASS-21 | 2.9 ± 3 | 2.7 ± 2.9 | 4.5 ± 3.7 |
Collected over Through study completion, an average of 2 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Serotonin Agonist 13 ug | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Serotonin Agonist 26 ug | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Placebo | Serotonin Agonist 13ug | Serotonin Agonist 26 ug | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 19 | 19 | 56 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo | Serotonin Agonist 13ug | Serotonin Agonist 26 ug | Total |
|---|---|---|---|---|
| Female | 7 | 6 | 6 | 19 |
| Male | 11 | 13 | 13 | 37 |
| Race (NIH/OMB)(Participants) | Placebo | Serotonin Agonist 13ug | Serotonin Agonist 26 ug | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 2 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 1 | 3 |
| White | 12 | 11 | 13 | 36 |
| More than one race | 5 | 4 | 3 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Serotonin Agonist 13ug | Serotonin Agonist 26 ug | Total |
|---|---|---|---|---|
| United States | 18 | 19 | 19 | 56 |
| Education - High School Education(Participants) | Placebo | Serotonin Agonist 13ug | Serotonin Agonist 26 ug | Total |
|---|---|---|---|---|
| Count of participants | 18 | 19 | 19 | 56 |
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University of Chicago