Effects of MDMA and Methylphenidate on Social Cognition

Social Cognition Clinical Trial

Official title:

Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616407
• Other study ID #: EK 382/11
• Secondary ID: 2012DR1018
• Status: Completed
• Phase: Early Phase 1
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Social Cognition

Intervention

Drug:
• 3,4-Methylenedioxymethamphetamine
75 mg per os, single dose
• Methylphenidate
40 mg per os, single dose
• Placebo
capsules identical to MDMA or methylphenidate but containing no active drug

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genetic polymorphisms	Effects of genetic polymorphisms on the response to MDMA	assessed after study completion
Primary	Effects on social cognition (emotion recognition and empathy)		7 hours
Secondary	Blood pressure (mmHg) and heart rate (beats per min)		7 hours
Secondary	Subjective effects	subjective effects are repetitively assessed by standardized questionnaires	7 hours
Secondary	Neuroendocrine plasma levels	neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogene,and progesterone	7 hours
Secondary	Drug plasma concentration	The plasma concentration of MDMA and MPH is repetitively assessed.	7 hours

External Links

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