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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

Tracking Information
First Submitted Date  ICMJE December 22, 2016
First Posted Date  ICMJE January 13, 2017
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date August 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • 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)
  • fMRI brain activity [ Time Frame: 1 hour ]
    Associations between subjective effects/alterations in emotion processing with fMRI amygdala BOLD activity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03019822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Resting State fMRI [ Time Frame: 1 hour ]
    Association between emotional enhancement and resting state fMRI neuronal activity
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
Official Title  ICMJE Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms
  • 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
    Interventions:
    • Drug: LSD
    • Drug: MDMA
    • Drug: Amphetamine
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: LSD
    • Drug: MDMA
    • Drug: Amphetamine
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: LSD
    • Drug: MDMA
    • Drug: Amphetamine
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: LSD
    • Drug: MDMA
    • Drug: Amphetamine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2018)
28
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2017)
24
Actual Study Completion Date September 4, 2018
Actual Primary Completion Date August 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03019822
Other Study ID Numbers  ICMJE BASEC 2016-01827
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP