Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction
- Registration Number
- NCT03527316
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo, MDMA MDMA Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase MDMA, Placebo MDMA Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase MDMA, Placebo Placebo Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase Placebo, MDMA Placebo Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
- Primary Outcome Measures
Name Time Method Fear extinction measured by Fear-potentiated startle 12 months b) Fear-potentiated startle to conditioned stimuli
Fear extinction measured by Skin conductance response 12 months a) Skin conductance response to conditioned stimuli
- Secondary Outcome Measures
Name Time Method Plasma concentration of Oxytocin 12 months Autonomic effects measured by Hearth rate 12 months Autonomic effects measured by vital signs
Subjective effects measured by Visual analog scales 12 months Visual analog scales, 0-100, 0 for 'not at all' and 100 for 'extremely'
Autonomic effects measured by Body temperature 12 months Autonomic effects measured by vital signs
Plasma concentration of MDMA 12 months Autonomic effects measured by Blood pressure 12 months Autonomic effects measured by vital signs
Subjective effects measured by State-trait anxiety inventory for state (STAI-S) 12 months
Trial Locations
- Locations (1)
Clinical Pharmacology & Toxicology, University Hospital Basel
🇨ðŸ‡Basel, Switzerland