Mood Effects of Serotonin Agonists

Sponsor

University of Chicago (Other)

Overall Status

Unknown status

CT.gov ID

NCT03790358

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of very low doses of serotonergic agonists on depressed mood in human volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lysergic Acid Diethylamide	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Mood Effects of Serotonin Agonists

Actual Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo	Drug: Lysergic Acid Diethylamide Drug will be administered in solution form.
Experimental: low dose MDMA 6.5ug dose of serotonin agonist	Drug: Lysergic Acid Diethylamide Drug will be administered in solution form.
Experimental: medium dose 13ug dose of serotonin agonist	Drug: Lysergic Acid Diethylamide Drug will be administered in solution form.
Experimental: high dose 26ug dose of serotonin agonist	Drug: Lysergic Acid Diethylamide Drug will be administered in solution form.

Outcome Measures

Primary Outcome Measures

Change From Baseline in Profile of Mood States (POMS) [End of study (Baseline - time 0 and approximately 8 weeks later)]
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Matthew Bona	Chicago	Illinois	United States	60637
2	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT03790358

Other Study ID Numbers:

15-1311

First Posted:

Dec 31, 2018

Last Update Posted:

Dec 31, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lysergic Acid Diethylamide

Study Results

No Results Posted as of Dec 31, 2018