HealthyEarly Phase 1LAMNCT03019822
Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
A Early Phase 1 study testing LSD, MDMA and Amphetamine in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LSD, MDMA and Amphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2017to 4 Sep 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
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.
- Conditions
- Healthy
- Being tested
- LSD, MDMA, Amphetamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSDDrug
Also called Lysergic Acid Diethylamide
100ug per os, single dose
MDMADrug
Also called 3,4-methylenedioxymethamphetamine
125mg per os, single dose
AmphetamineDrug
Also called d-amphetamine sulfate
40.3mg per os, single dose
PlaceboDrug
Capsules containing mannitol looking identical to the other drugs
| Study group | Role | What they receive |
|---|---|---|
| Placebo, LSD, d-Amphetamine, MDMA | Other | 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 Receives: Drug: LSD; Drug: MDMA; Drug: Amphetamine; Drug: Placebo |
| LSD, d-Amphetamine, MDMA, Placebo | Other | 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 Receives: Drug: LSD; Drug: MDMA; Drug: Amphetamine; Drug: Placebo |
| d-Amphetamine, MDMA, LSD, Placebo | Other | 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 Receives: Drug: LSD; Drug: MDMA; Drug: Amphetamine; Drug: Placebo |
| MDMA, LSD, Placebo, d-Amphetamine,, | Other | 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 Receives: Drug: LSD; Drug: MDMA; Drug: Amphetamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional enhancement as determined by fMRI
Emotional enhancement (empathy, oxytocin, mood perception, fMRI amygdala blood oxygen level-dependent (BOLD) signal reactivity to fearful stimuli)
Measured: 12 hours
fMRI brain activity
Associations between subjective effects/alterations in emotion processing with fMRI amygdala BOLD activity
Measured: 1 hour
Secondary outcomes (4)
Resting State fMRI
Association between emotional enhancement and resting state fMRI neuronal activity
Measured: 1 hour
Effect Modulation by personality traits (assessed with questionnaires),
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
Measured: 12 hours
Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)
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
Measured: 12 hours
Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)
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
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion11 Aug 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias E Liechti, MD, MAS, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019822
- Sponsor's protocol ID
- BASEC 2016-01827
- Acronym
- LAM
- Status last verified
- Oct 2018
- First submitted
- 22 Dec 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
- ClinicalTrials.gov ID
- NCT03019822
- Acronym / sponsor ID
- LAM / BASEC 2016-01827
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 11 Aug 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo, LSD, d-Amphetamine, MDMA | Other | Drug: LSD, Drug: MDMA, Drug: Amphetamine, Drug: PlaceboCross-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 |
| LSD, d-Amphetamine, MDMA, Placebo | Other | Drug: LSD, Drug: MDMA, Drug: Amphetamine, Drug: PlaceboCross-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 |
| d-Amphetamine, MDMA, LSD, Placebo | Other | Drug: LSD, Drug: MDMA, Drug: Amphetamine, Drug: PlaceboCross-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 |
| MDMA, LSD, Placebo, d-Amphetamine,, | Other | Drug: LSD, Drug: MDMA, Drug: Amphetamine, Drug: PlaceboCross-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 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSDAlso: Lysergic Acid Diethylamide100ug per os, single dose | Drug | LSD, d-Amphetamine, MDMA, Placebo, MDMA, LSD, Placebo, d-Amphetamine,,, Placebo, LSD, d-Amphetamine, MDMA, d-Amphetamine, MDMA, LSD, Placebo |
| MDMAAlso: 3,4-methylenedioxymethamphetamine125mg per os, single dose | Drug | LSD, d-Amphetamine, MDMA, Placebo, MDMA, LSD, Placebo, d-Amphetamine,,, Placebo, LSD, d-Amphetamine, MDMA, d-Amphetamine, MDMA, LSD, Placebo |
| AmphetamineAlso: d-amphetamine sulfate40.3mg per os, single dose | Drug | LSD, d-Amphetamine, MDMA, Placebo, MDMA, LSD, Placebo, d-Amphetamine,,, Placebo, LSD, d-Amphetamine, MDMA, d-Amphetamine, MDMA, LSD, Placebo |
| PlaceboCapsules containing mannitol looking identical to the other drugs | Drug | LSD, d-Amphetamine, MDMA, Placebo, MDMA, LSD, Placebo, d-Amphetamine,,, Placebo, LSD, d-Amphetamine, MDMA, d-Amphetamine, MDMA, LSD, Placebo |
Primary outcome
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
4 secondary outcomes
Resting State fMRI
Time frame: 1 hour
Effect Modulation by personality traits (assessed with questionnaires),
Time frame: 12 hours
Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)
Time frame: 12 hours
Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias E Liechti, MD, MAS principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LSD, MDMA and Amphetamine in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional enhancement as determined by fMRI (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.