Effects of MDMA and Methylphenidate on Social Cognition
Early Phase 1
Completed
- Conditions
- Social Cognition
- Interventions
- Registration Number
- NCT01616407
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
The purpose of this study is to assess and compare the effects of a single dose of 3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective perception for positive and impairs perception for negative emotional stimuli compared to placebo or MPH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Sufficient understanding of the German language
- Subjects understand 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 xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
- Participants must be willing not to drive a traffic vehicle in the evening of the study day.
- Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.
- Body mass index: 18-25 kg/m2
Exclusion Criteria
- Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
- Current or previous psychotic or affective disorder
- Psychotic or affective disorder in first-degree relatives
- Prior illicit drug use (except THC-containing products) more than 5 times or any time within the previous 2 months.
- Pregnant or nursing women.
- Participation in another clinical trial (currently or within the last 30 days)
- Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MDMA, methylphenidate, placebo 3,4-Methylenedioxymethamphetamine Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but three treatment conditions in the same subject. MDMA, methylphenidate, placebo Placebo Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but three treatment conditions in the same subject. MDMA, methylphenidate, placebo Methylphenidate Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but three treatment conditions in the same subject.
- Primary Outcome Measures
Name Time Method Effects on social cognition (emotion recognition and empathy) 7 hours
- Secondary Outcome Measures
Name Time Method Blood pressure (mmHg) and heart rate (beats per min) 7 hours Subjective effects 7 hours subjective effects are repetitively assessed by standardized questionnaires
Neuroendocrine plasma levels 7 hours neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogene,and progesterone
Drug plasma concentration 7 hours The plasma concentration of MDMA and MPH is repetitively assessed.
Trial Locations
- Locations (1)
University Hospital Basel
🇨🇭Basel, Switzerland