Randomised, double-blind, crossover Phase I study (n=16) testing duloxetine (120 mg, two pre-doses) versus placebo as a pretreatment to MDMA (125 mg) in healthy volunteers to assess pharmacodynamic, cardiovascular, and pharmacokinetic effects.
Healthy volunteers undergo four experimental sessions in a randomised double-blind crossover comparing duloxetine 120 mg (two pre-doses) or placebo with MDMA 125 mg or placebo; subjective, cardiovascular and plasma PK measures are collected repeatedly.
Primary aim is to determine whether combined 5-HT and NE reuptake inhibition by duloxetine attenuates MDMA-induced subjective and cardiovascular effects and alters MDMA pharmacokinetics.
Randomised, double-blind, within-subject crossover with four sessions testing duloxetine or placebo pretreatment and MDMA or placebo.
Duloxetine 120 mg given as two pre-doses before MDMA; timing reported inconsistently in source text (16 h & 4 h vs 12 h & 2 h).
This study analysed data from five separate clinical trials (n=80) that explored the effects of MDMA on pupillary light reflex and the effects following pretreatment with reboxetine, duloxetine, clonidine, carvedilol, and doxazosin, respectively. MDMA produced mydriasis, prolonged the latency, reduced the response to light and shortened the recovery time and this impairment returned to normal 6 hours post-treatment. Only reboxetine and duloxetine interacted with the effects of MDMA on pupillary function.