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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03019822
Collaborator
(none)
28
1
4
19.1
1.5

Study Details

Study Description

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
Early Phase 1

Study Design

Study Type:
Interventional
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 :
Feb 1, 2017
Actual Primary Completion Date :
Aug 11, 2018
Actual Study Completion Date :
Sep 4, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • Lysergic Acid Diethylamide
  • Drug: MDMA
    125mg per os, single dose
    Other Names:
  • 3,4-methylenedioxymethamphetamine
  • Drug: Amphetamine
    40.3mg per os, single dose
    Other Names:
  • d-amphetamine sulfate
  • Drug: Placebo
    Capsules containing mannitol looking identical to the other drugs

    Other: 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 Names:
  • Lysergic Acid Diethylamide
  • Drug: MDMA
    125mg per os, single dose
    Other Names:
  • 3,4-methylenedioxymethamphetamine
  • Drug: Amphetamine
    40.3mg per os, single dose
    Other Names:
  • d-amphetamine sulfate
  • Drug: Placebo
    Capsules containing mannitol looking identical to the other drugs

    Other: 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 Names:
  • Lysergic Acid Diethylamide
  • Drug: MDMA
    125mg per os, single dose
    Other Names:
  • 3,4-methylenedioxymethamphetamine
  • Drug: Amphetamine
    40.3mg per os, single dose
    Other Names:
  • d-amphetamine sulfate
  • Drug: Placebo
    Capsules containing mannitol looking identical to the other drugs

    Other: 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 Names:
  • Lysergic Acid Diethylamide
  • Drug: MDMA
    125mg per os, single dose
    Other Names:
  • 3,4-methylenedioxymethamphetamine
  • Drug: Amphetamine
    40.3mg per os, single dose
    Other Names:
  • d-amphetamine sulfate
  • Drug: Placebo
    Capsules containing mannitol looking identical to the other drugs

    Outcome Measures

    Primary Outcome Measures

    1. Emotional enhancement as determined by fMRI [12 hours]

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

    2. fMRI brain activity [1 hour]

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

    Secondary Outcome Measures

    1. Resting State fMRI [1 hour]

      Association between emotional enhancement and resting state fMRI neuronal activity

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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT03019822
    Other Study ID Numbers:
    • BASEC 2016-01827
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Oct 15, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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:

    Study Results

    No Results Posted as of Oct 15, 2018