Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing

NCT ID: NCT03019822

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we predict associations between subjective effects/alterations in emotion processing tests and functional imaging (fMRI) activity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo, LSD, d-Amphetamine, MDMA

Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, lysergic acid diethylamide (LSD), d-Amphetamine or methylenedioxymethamphetamine (MDMA) and followed by all other drugs each separated by a wash-out phase

Group Type OTHER

LSD

Intervention Type DRUG

100ug per os, single dose

MDMA

Intervention Type DRUG

125mg per os, single dose

Amphetamine

Intervention Type DRUG

40.3mg per os, single dose

Placebo

Intervention Type DRUG

Capsules containing mannitol looking identical to the other drugs

LSD, d-Amphetamine, MDMA, Placebo

Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase

Group Type OTHER

LSD

Intervention Type DRUG

100ug per os, single dose

MDMA

Intervention Type DRUG

125mg per os, single dose

Amphetamine

Intervention Type DRUG

40.3mg per os, single dose

Placebo

Intervention Type DRUG

Capsules containing mannitol looking identical to the other drugs

d-Amphetamine, MDMA, LSD, Placebo

Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase

Group Type OTHER

LSD

Intervention Type DRUG

100ug per os, single dose

MDMA

Intervention Type DRUG

125mg per os, single dose

Amphetamine

Intervention Type DRUG

40.3mg per os, single dose

Placebo

Intervention Type DRUG

Capsules containing mannitol looking identical to the other drugs

MDMA, LSD, Placebo, d-Amphetamine,,

Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase

Group Type OTHER

LSD

Intervention Type DRUG

100ug per os, single dose

MDMA

Intervention Type DRUG

125mg per os, single dose

Amphetamine

Intervention Type DRUG

40.3mg per os, single dose

Placebo

Intervention Type DRUG

Capsules containing mannitol looking identical to the other drugs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LSD

100ug per os, single dose

Intervention Type DRUG

MDMA

125mg per os, single dose

Intervention Type DRUG

Amphetamine

40.3mg per os, single dose

Intervention Type DRUG

Placebo

Capsules containing mannitol looking identical to the other drugs

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lysergic Acid Diethylamide 3,4-methylenedioxymethamphetamine d-amphetamine sulfate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age between 25 and 50 years.
2. Sufficient understanding of the German language
3. Subjects understand the procedures and the risks associated with the study.
4. Participants must be willing to adhere to the protocol and sign the consent form.
5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
6. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session. Women and men must agree to use an effective form of birth control (double-barrier method).
9. Body mass index 18-29 kg/m2.

Exclusion Criteria

1. Chronic or acute medical condition
2. Hypertension (\>140/90 mmHg) or Hypotension (SBP\<85 mmHg)
3. Current or previous major psychiatric disorder
4. Psychotic disorder in first-degree relatives
5. Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
6. Pregnant or nursing women.
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medications that may interfere with the effects of the study medications (any psychiatric medications).
9. fMRI related criteria including: metal implants (clips from operations, cochlea, large red/yellow tattoos in the neck area)
10. Tobacco smoking (\>10 cigarettes/day)
11. Consumption of alcoholic drinks (\>10/week)
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthias E Liechti, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BASEC 2016-01827

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Role of Brain Dopamine in Chronic Pain
NCT05285683 RECRUITING PHASE2
Emotions, Dopamine, Brain and Body
NCT06171087 RECRUITING PHASE4
Spatiotemporal Dynamics of the Human Emotion Network
NCT05152992 ENROLLING_BY_INVITATION NA
Drugs Brain and Behavior (DDP)
NCT04642820 COMPLETED EARLY_PHASE1