Sixteen healthy subjects (eight men, eight women) with a mean±SD age of 26.1±6.0 years participated in the study. The allocation to treatment order was performed by drawing from blocks of eight different balanced drug treatment sequences by a pharmacist not involved in the study. Each code was stored in a sealed envelope until the termination of the study. Data from all 16 subjects were available for the final analysis (Figure 1 ). The sample-size estimation showed that 13 subjects would be needed to detect a meaningful reduction of 20% of the MDMA drug effect by duloxetine with more than 80% power using a within-subjects study design. The exclusion criteria included the following; (i) age <18 or >45 years, (ii) pregnancy determined by a urine test before each session, (iii) body mass index <18.5 kg/m2 or >25 kg/m2, (iv) personal or family (first-degree relative) history of psychiatric disorder (determined by the structured clinical interview of Axis I and Axis II disorders according the Diagnostic and Statistical Manual of Mental Disorders, 4th edition [18] supplemented by the SCL-90-R Symptom Checklist [19] (link), [20] (link)
(v) regular use of medications, (vi) chronic or acute physical illness assessed by physical examination, electrocardiogram, standard hematological, and chemical blood analyses, (vii) smoking more than 10 cigarettes per day, (viii) a lifetime history of using illicit drugs more than five times with the exception of cannabis, (ix) illicit drug use within the last 2 months, and (x) illicit drug use during the study determined by urine tests conducted before the test sessions. None of the 16 subjects had used ecstasy previously. The subjects were asked to abstain from excessive alcohol consumption between the test sessions and limit their alcohol use to one glass on the day before the test session. All of the subjects were phenotyped for cytochrome P450 (CYP) 2D6 activity using dextromethorphan. Thirteen extensive, two intermediate, and one poor CYP 2D6 metabolizer were identified in the study. The female subjects were investigated during the follicular phase (day 2–14) of their menstrual cycle.
(v) regular use of medications, (vi) chronic or acute physical illness assessed by physical examination, electrocardiogram, standard hematological, and chemical blood analyses, (vii) smoking more than 10 cigarettes per day, (viii) a lifetime history of using illicit drugs more than five times with the exception of cannabis, (ix) illicit drug use within the last 2 months, and (x) illicit drug use during the study determined by urine tests conducted before the test sessions. None of the 16 subjects had used ecstasy previously. The subjects were asked to abstain from excessive alcohol consumption between the test sessions and limit their alcohol use to one glass on the day before the test session. All of the subjects were phenotyped for cytochrome P450 (CYP) 2D6 activity using dextromethorphan. Thirteen extensive, two intermediate, and one poor CYP 2D6 metabolizer were identified in the study. The female subjects were investigated during the follicular phase (day 2–14) of their menstrual cycle.
Free full text: Click here
