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Mood Effects of Serotonin Agonists Extended

NCT ID: NCT03934710

Last Updated: 2023-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2021-06-07

Brief Summary

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In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.

Detailed Description

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drug will be administered in solution form

Serotonin agonist 13ug

13ug of serotonin agonist

Group Type EXPERIMENTAL

Serotonin agonist - 13ug

Intervention Type DRUG

13ug lysergic acid diethylamide

Serotonin agonist 26ug

26ug of serotonin agonist

Group Type EXPERIMENTAL

Serotonin agonist - 26ug

Intervention Type DRUG

26ug lysergic acid diethylamide

Interventions

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Placebo

Drug will be administered in solution form

Intervention Type DRUG

Serotonin agonist - 13ug

13ug lysergic acid diethylamide

Intervention Type DRUG

Serotonin agonist - 26ug

26ug lysergic acid diethylamide

Intervention Type DRUG

Other Intervention Names

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LSD LSD

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harriet de Wit

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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Matthew Bona

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R01DA002812

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB18-1183

Identifier Type: -

Identifier Source: org_study_id