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

University Hospital Basel

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Drug: MDMA; Drug: Amphetamine; Drug: Placebo; Drug: LSD

Study type: Interventional

Funder types: Other

Identifiers

NCT03019822

BASEC 2016-01827

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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28 participants in 4 patient groups

Placebo, LSD, d-Amphetamine, MDMA

Other group

Description:

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

Treatment:

Drug: LSD

Drug: Amphetamine

Drug: Placebo

Drug: MDMA

LSD, d-Amphetamine, MDMA, Placebo

Other group

Description:

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

Treatment:

Drug: LSD

Drug: Amphetamine

Drug: Placebo

Drug: MDMA

d-Amphetamine, MDMA, LSD, Placebo

Other group

Description:

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

Treatment:

Drug: LSD

Drug: Amphetamine

Drug: Placebo

Drug: MDMA

MDMA, LSD, Placebo, d-Amphetamine,,

Other group

Description:

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

Treatment:

Drug: LSD

Drug: Amphetamine

Drug: Placebo

Drug: MDMA