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HealthyEarly Phase 1MFENCT03527316

Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction

A Early Phase 1 study testing MDMA in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Serotonin and oxytocin play a role in fear conditioning and fear extinction learning, psychological processes that are critically involved in psychiatric disorders such as posttraumatic stress disorder (PTSD). Specifically, administration of oxytocin has been shown to facilitate fear extinction in humans. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
MDMA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSwitzerland
Study dates
18 Oct 2019to 24 Dec 2020
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 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male
  • Age between 18 and 50 years.
  • Understanding of the German language.
  • Understanding 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.
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  • 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.
  • Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
  • 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) of more than 5 times or any time within the previous month.
  • Participation in another clinical trial (currently or within the last 30 days)
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  • Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
  • Tobacco smoking (>10 cigarettes/day)
  • Consumption of alcoholic standard drinks (>10/week or >120 g ethanol/week)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Clinical Pharmacology & Toxicology, University Hospital Basel

    Basel, 4056

Other trials in Switzerland

About this study

Official title: Effect of MDMA (Serotonin Release) on Fear Extinction

Serotonin and oxytocin play a role in fear conditioning and fear extinction learning, psychological processes that are critically involved in psychiatric disorders such as posttraumatic stress disorder (PTSD). Specifically, administration of oxytocin has been shown to facilitate fear extinction in humans. Similarly, substances that release serotonin and oxytocin such as MDMA have been shown to enhance the extinction of fear memory in animals. However, there are no data on the effects of MDMA on fear extinction in humans. Therefore, the primary aim of this study is to investigate the role of acute serotonin release in the effects of fear extinction. MDMA will be used as pharmacological tool to induce serotonin release in this study.

Conditions
Healthy
Being tested
MDMA, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDMADrug

    Also called 3,4-Methylenedioxymethamphetamine

    125 mg MDMA per os, single dose

  • PlaceboDrug

    Capsules containing mannitol looking identical to the other drugs.

Study groups in NCT03527316
Study groupRoleWhat they receive
MDMA, PlaceboExperimentalCross-over within-subjects design with both treatment conditions, separated by a wash-out phase
Receives: Drug: MDMA; Drug: Placebo
Placebo, MDMAExperimentalCross-over within-subjects design with both treatment conditions, separated by a wash-out phase
Receives: Drug: MDMA; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fear extinction measured by Skin conductance response

    1. Skin conductance response to conditioned stimuli

    Measured: 12 months

  2. Fear extinction measured by Fear-potentiated startle

    1. Fear-potentiated startle to conditioned stimuli

    Measured: 12 months

Secondary outcomes (7)

  1. Plasma concentration of Oxytocin

    Measured: 12 months

  2. Subjective effects measured by Visual analog scales

    Visual analog scales, 0-100, 0 for 'not at all' and 100 for 'extremely'

    Measured: 12 months

  3. Autonomic effects measured by Blood pressure

    Autonomic effects measured by vital signs

    Measured: 12 months

  4. Autonomic effects measured by Hearth rate

    Autonomic effects measured by vital signs

    Measured: 12 months

  5. Autonomic effects measured by Body temperature

    Autonomic effects measured by vital signs

    Measured: 12 months

  6. Subjective effects measured by State-trait anxiety inventory for state (STAI-S)

    Measured: 12 months

  7. Plasma concentration of MDMA

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2018
  2. Study start18 Oct 2019
  3. Primary completion10 Dec 2020
  4. Study completion24 Dec 2020

Resources

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03527316
Sponsor's protocol ID
BASEC 2017-01947
Acronym
MFE
Status last verified
Jan 2022
First submitted
4 May 2018
Last updated
19 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vizeli P, Straumann I, Duthaler U, Varghese N, Eckert A, Paulus MP, Risbrough V, Liechti ME. Effects of 3,4-Methylenedioxymethamphetamine on Conditioned Fear Extinction and Retention in a Crossover Study in Healthy Subjects. Front Pharmacol. 2022 Jul 13;13:906639. doi: 10.3389/fphar.2022.906639. eCollection 2022.

    PubMed 35910354

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MDMA 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 9 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 19 Jan 2022. 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?

Fear extinction measured by Skin conductance response (time frame: 12 months). 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?

On the ClinicalTrials.gov record for NCT03527316, which also lists 1 linked publication.

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 19 Jan 2022.

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