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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDMA, Placebo | Experimental | Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase |
|
| Placebo, MDMA | Experimental | Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDMA | Drug | 125 mg MDMA per os, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Oxytocin | 12 months | |
| Subjective effects measured by Visual analog scales | Visual analog scales, 0-100, 0 for 'not at all' and 100 for 'extremely' | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias E Liechti, MD, MAS | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology & Toxicology, University Hospital Basel | Basel | 4056 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35910354 | Derived | 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. |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Placebo | Drug | Capsules containing mannitol looking identical to the other drugs. |
|
| Autonomic effects measured by Blood pressure | Autonomic effects measured by vital signs | 12 months |
| Autonomic effects measured by Hearth rate | Autonomic effects measured by vital signs | 12 months |
| Autonomic effects measured by Body temperature | Autonomic effects measured by vital signs | 12 months |
| Subjective effects measured by State-trait anxiety inventory for state (STAI-S) | 12 months |
| Plasma concentration of MDMA | 12 months |
| Organic Chemicals |