NCT03181763 is a Phase 1 clinical trial of Midomafetamine in Startle Response, sponsored by Lykos Therapeutics.

Who is sponsoring NCT03181763?

NCT03181763 is sponsored by Lykos Therapeutics.

What drugs are being tested in NCT03181763?

Interventions in NCT03181763: Placebo, Midomafetamine, Acoustic startle.

What condition does NCT03181763 study?

NCT03181763 studies Startle Response.

Is NCT03181763 still recruiting?

NCT03181763 is currently completed. Last updated 4 March 2025.

Last reviewed 2025-03-04 · How we verify

NCT03181763

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of MDMA on Startle Response

Completed Phase 1 Last updated 4 March 2025

What this trial tests

Phase 1 trial testing Placebo in Startle Response in 34 participants. Completed in 1 August 2020.

Timeline

14 March 2017

Primary endpoint
1 August 2020

1 August 2020

Quick facts

Lead sponsor	Lykos Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	34
Start date	14 March 2017
Primary completion	1 August 2020
Estimated completion	1 August 2020
Sites	1 location across United States

Drugs / interventions tested

Placebo
Midomafetamine — full drug profile →
Acoustic startle

Conditions studied

Startle Response — all drugs for Startle Response →

Sponsor

Lykos Therapeutics — full company profile →

Who can join

Adults 21 to 55, any sex, with Startle Response. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn if MDMA impacts startle response in healthy participants. The main question it aims to answer is: Does MDMA impact participant's performance on a startle test? Researchers will compare healthy volunteers who have taken MDMA to those who have taken placebo. Participants will first undergo a 1-hour startle test. The next day, they will be randomized to receive either MDMA or placebo followed by another startle test and vitals signs and blood measurements. Participants will return the next day for a final startle test. Their sleep will be tracked by a Fitbit device.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Reviewing the Potential of Psychedelics for the Treatment of PTSD.
Krediet E, Bostoen T, Breeksema J, van Schagen A, et al · · 2020 · cited 134× · PMID 32170326 · DOI 10.1093/ijnp/pyaa018
A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults.
Maples-Keller JL, Norrholm SD, Burton M, Reiff C, et al · · 2022 · cited 39× · PMID 35166140 · DOI 10.1177/02698811211069124
The Use of Psychedelics in the Treatment of Medical Conditions: An Analysis of Currently Registered Psychedelics Studies in the American Drug Trial Registry.
Kurtz JS, Patel NA, Gendreau JL, Yang C, et al · · 2022 · cited 19× · PMID 36259015 · DOI 10.7759/cureus.29167

Verify or expand the search:

Other trials of Midomafetamine

Trials testing the same drug.

NCT04784143 — Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD · Phase 2 · terminated
NCT04077437 — A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) · Phase 3 · completed
NCT03282123 — Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD · Phase 2 · completed
NCT01458327 — Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial · Phase 2 · completed
NCT04438512 — A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD · no longer available

Other Lykos Therapeutics trials

Trials by the same sponsor.

NCT05147402 — Food Effects on Bioavailability of MDMA in Healthy Volunteers · Phase 1 · completed
NCT04784143 — Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD · Phase 2 · terminated
NCT04714359 — A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD · Phase 3 · completed
NCT05066282 — Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD · completed
NCT04077437 — A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03181763 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lykos Therapeutics
Last refreshed: 4 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03181763.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing