Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA002812 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Serotonin agonist 13ug | Experimental | 13ug of serotonin agonist |
|
| Serotonin agonist 26ug | Experimental | 26ug of serotonin agonist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Drug will be administered in solution form |
| |
| Serotonin agonist - 13ug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of session 5, approximately 2 weeks from baseline |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harriet de Wit | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matthew Bona | Chicago | Illinois | 60637 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo: Drug will be administered in solution form |
| FG001 | Serotonin Agonist | 13ug of serotonin agonist Serotonin agonist: 13ug lysergic acid diethylamide |
| FG002 | Serotonin Agonist | 26ug of serotonin agonist: 26ug lysergic acid diethylamide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo: Drug will be administered in solution form |
| BG001 | Serotonin Agonist 13ug | 13ug of serotonin agonist Serotonin agonist: 13ug lysergic acid diethylamide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | End of session 5, approximately 2 weeks from baseline |
|
Through study completion, an average of 2 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Placebo: Drug will be administered in solution form | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harriet de Wit | University of Chicago | 7737023560 | dewitlab@yoda.bsd.uchicago.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2019 | Jul 19, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017366 | Serotonin Receptor Agonists |
| D008238 | Lysergic Acid Diethylamide |
| ID | Term |
|---|---|
| D018490 | Serotonin Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
Randomized
Not provided
Not provided
Not provided
| Drug |
13ug lysergic acid diethylamide |
|
|
| Serotonin agonist - 26ug | Drug | 26ug lysergic acid diethylamide |
|
|
| BG002 | Serotonin Agonist 26 ug | 26ug of serotonin agonist Serotonin agonist: 26ug lysergic acid diethylamide |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education - High School Education | Count of Participants | Participants |
|
| OG002 | Serotonin Agonist 26ug | Serotonin agonist: 26 ug lysergic acid diethyl amide |
|
|
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Serotonin Agonist 13 ug | 13ug of serotonin agonist Serotonin agonist: 13ug lysergic acid diethylamide | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Serotonin Agonist 26 ug | 26ug of serotonin agonist Serotonin agonist: 26ug lysergic acid diethylamide | 0 | 19 | 0 | 19 | 0 | 19 |
Not provided
Not provided
Not provided
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D008237 | Lysergic Acid |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |