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OpenTrials
Completed

NCT Number: NCT03019822

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

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.

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Key information

Conditions

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 25 and 50 years.
  • Sufficient understanding of the German language
  • Subjects understand the procedures and the risks associated with the study.
  • Participants must be willing to adhere to the protocol and sign the consent form.
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • 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.
  • Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
  • 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).
  • Body mass index 18-29 kg/m2.

Exclusion criteria

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

Treatment and study plan

LSD

Drug

100ug per os, single dose

Other names: Lysergic Acid Diethylamide

MDMA

Drug

125mg per os, single dose

Other names: 3,4-methylenedioxymethamphetamine

Amphetamine

Drug

40.3mg per os, single dose

Other names: d-amphetamine sulfate

Placebo

Drug

Capsules containing mannitol looking identical to the other drugs

Primary outcomes

  1. Emotional enhancement as determined by fMRI

    Time frame: 12 hours

    Emotional enhancement (empathy, oxytocin, mood perception, fMRI amygdala blood oxygen level-dependent (BOLD) signal reactivity to fearful stimuli)

  2. fMRI brain activity

    Time frame: 1 hour

    Associations between subjective effects/alterations in emotion processing with fMRI amygdala BOLD activity

Secondary outcomes

  1. Resting State fMRI

    Time frame: 1 hour

    Association between emotional enhancement and resting state fMRI neuronal activity

  2. Effect Modulation by personality traits (assessed with questionnaires),

    Time frame: 12 hours

    Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject

  3. Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)

    Time frame: 12 hours

    Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject

  4. Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)

    Time frame: 12 hours

    Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: LAM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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