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

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ClinicalTrials.gov Identifier: NCT03019822
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LSD Drug: MDMA Drug: Amphetamine Drug: Placebo Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 11, 2018
Actual Study Completion Date : September 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: LSD
100ug per os, single dose
Other Name: Lysergic Acid Diethylamide

Drug: MDMA
125mg per os, single dose
Other Name: 3,4-methylenedioxymethamphetamine

Drug: Amphetamine
40.3mg per os, single dose
Other Name: d-amphetamine sulfate

Drug: Placebo
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
Drug: LSD
100ug per os, single dose
Other Name: Lysergic Acid Diethylamide

Drug: MDMA
125mg per os, single dose
Other Name: 3,4-methylenedioxymethamphetamine

Drug: Amphetamine
40.3mg per os, single dose
Other Name: d-amphetamine sulfate

Drug: Placebo
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
Drug: LSD
100ug per os, single dose
Other Name: Lysergic Acid Diethylamide

Drug: MDMA
125mg per os, single dose
Other Name: 3,4-methylenedioxymethamphetamine

Drug: Amphetamine
40.3mg per os, single dose
Other Name: d-amphetamine sulfate

Drug: Placebo
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
Drug: LSD
100ug per os, single dose
Other Name: Lysergic Acid Diethylamide

Drug: MDMA
125mg per os, single dose
Other Name: 3,4-methylenedioxymethamphetamine

Drug: Amphetamine
40.3mg per os, single dose
Other Name: d-amphetamine sulfate

Drug: Placebo
Capsules containing mannitol looking identical to the other drugs




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019822


Locations
Switzerland
University Hospital Basel
Basel, Basel Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03019822     History of Changes
Other Study ID Numbers: BASEC 2016-01827
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dopamine
Amphetamine
Dextroamphetamine
Serotonin
N-Methyl-3,4-methylenedioxyamphetamine
Lysergic Acid Diethylamide
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Serotonin Receptor Agonists
Serotonin Agents
Central Nervous System Stimulants
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Hallucinogens
Psychotropic Drugs
Serotonin Antagonists