Evaluation of MDMA on Startle Response

NCT03181763 | Completed Phase 1 FDA Drug

• 1 other identifier: MPVA-4
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Startle Response

Keywords

MDMA; Startle response; sleep; Oxytocin

Outcome Measures

Primary Outcomes (1)

• EMG of right orbicularis oculi muscle

  Description: Measure of startle response to noise after fear extinction training

  Four days post-enrollment

Secondary Outcomes (41)

• Systolic blood pressure pre-drug

  5 minutes pre-drug

• Systolic blood pressure 45 min post-drug

  45 minutes post-drug

• Systolic blood pressure 1 h 15 min post-drug

  1 hour 15 minutes post drug

• Systolic blood pressure 1 h 45 min post-drug

  1 hour 45 minutes post drug

• Systolic blood pressure 3 h post-drug

  3 hours post-drug

Study Arms (2)

100 mg MDMA HCl

EXPERIMENTAL

Participants receive 100 mg MDMA HCl on their second visit

Drug: Midomafetamine; Behavioral: Acoustic startle

Placebo

PLACEBO COMPARATOR

Participants receive inactive placebo on their second visit

Drug: Placebo; Behavioral: Acoustic startle

Interventions

Placebo DRUG

Participants will receive inactive placebo on their second visit.

Also known as: inactive placebo, lactose

Placebo

Midomafetamine DRUG

Participants will receive 100 mg midomafetamine HCl on their second visit

Also known as: 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HCl

100 mg MDMA HCl

Acoustic startle BEHAVIORAL

Startle assessment

Also known as: startle test

100 mg MDMA HCl; Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Persons aged 21 to 55.
• Ability to visually read and understand English language.
• Live within in metro Atlanta area
• Previously used MDMA in a recreational or research setting
• If a person is of childbearing potential (able to bear children), they must have a negative pregnancy test at study entry and prior to the Experimental Session. They must agree to use adequate birth control through 10 days after the last dose of MDMA. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or male.
• (For sub-study measuring serum oxytocin) Willing to have periodic blood draws

You may not qualify if:

• Upon review of medical or psychiatric history, have any current or past diagnosis that would be considered a risk to participating in the study.
• Are abusing illegal drugs.
• Current use of any psychoactive medications, including antidepressants, mood stabilizers, sedatives, stimulants, antipsychotics, anxiolytics, or beta-blockers
• Are not able to give adequate informed consent.
• Uncontrolled hypertension, or clinically significant cardiac arrhythmia, as detected by electrocardiogram.
• Currently pregnant or breast-feeding.
• History of acute angle glaucoma.
• Hearing impairment as assessed by audiometer; unable to detect tones below 40 dB in right or left ear.

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• Maples-Keller JL, Norrholm SD, Burton M, Reiff C, Coghlan C, Jovanovic T, Yasinski C, Jarboe K, Rakofsky J, Rauch S, Dunlop BW, Rothbaum BO. A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults. J Psychopharmacol. 2022 Mar;36(3):368-377. doi: 10.1177/02698811211069124. Epub 2022 Feb 15.

  PMID: 35166140 DERIVED

MeSH Terms

Interventions

Lactose; N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Barbara Rothbaum

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Blinded, placebo between group; all participants undergo fear conditioning, with half randomized to receive 100 mg MDMA and half receiving inactive placebo

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: March 14, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)