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

NCT03527316 | Completed Early Phase 1 DMC

• 1 other identifier: BASEC 2017-01947
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Fear extinction measured by Skin conductance response

  a) Skin conductance response to conditioned stimuli

  12 months

• Fear extinction measured by Fear-potentiated startle

  b) Fear-potentiated startle to conditioned stimuli

  12 months

Secondary Outcomes (7)

• Plasma concentration of Oxytocin

  12 months

• Subjective effects measured by Visual analog scales

  12 months

• Autonomic effects measured by Blood pressure

  12 months

• Autonomic effects measured by Hearth rate

  12 months

• Autonomic effects measured by Body temperature

  12 months

Study Arms (2)

MDMA, Placebo

EXPERIMENTAL

Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase

Drug: MDMA; Drug: Placebo

Placebo, MDMA

EXPERIMENTAL

Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase

Drug: MDMA; Drug: Placebo

Interventions

MDMA DRUG

125 mg MDMA per os, single dose

Also known as: 3,4-Methylenedioxymethamphetamine

MDMA, Placebo; Placebo, MDMA

Placebo DRUG

Capsules containing mannitol looking identical to the other drugs.

MDMA, Placebo; Placebo, MDMA

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, 4056, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35910354 DERIVED

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Matthias E Liechti, MD, MAS

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 17, 2018
• Study Start: October 18, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 24, 2020
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)