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

NCT ID: NCT03527316

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2020-12-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

MDMA, Placebo

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

Group Type: EXPERIMENTAL

MDMA

Intervention Type: DRUG

125 mg MDMA per os, single dose

Placebo

Intervention Type: DRUG

Capsules containing mannitol looking identical to the other drugs.

Placebo, MDMA

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

Group Type: EXPERIMENTAL

MDMA

Intervention Type: DRUG

125 mg MDMA per os, single dose

Placebo

Intervention Type: DRUG

Capsules containing mannitol looking identical to the other drugs.

Interventions

MDMA

125 mg MDMA per os, single dose

Intervention Type: DRUG

Placebo

Capsules containing mannitol looking identical to the other drugs.

Intervention Type: DRUG

Other Intervention Names

3,4-Methylenedioxymethamphetamine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias E Liechti, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 35910354 (View on PubMed)

Other Identifiers

BASEC 2017-01947

Identifier Type: -

Identifier Source: org_study_id