Aims: Dasotraline is a novel dopamine norepinephrine reuptake inhibitor currently being investigated in clinical studies for the treatment of ADHD at doses up to 8 mg/d. It was hypothesized that dasotraline would be characterized by minimal subjective reinforcing effects based on potent inhibition of norepinephrine reuptake and its pharmacokinetics of slow absorption/elimination in humans. This study evaluated the abuse potential of dasotraline compared to placebo and methylphenidate. Methods: Recreational stimulant users (N= 48) who had specific experience with cocaine, and who were able to distinguish methylphenidate (60 mg) versus placebo in a qualification session, were randomized to a 6-period, double-blind, crossover treatment phase. Treatment phase consisted of placebo, methylphenidate (40 mg, 80 mg), and dasotraline (8 mg, 16 mg, 36 mg). Subjective measures were evaluated over 72 h postdose. The primary endpoint was Emax on the Drug Liking Visual Analog Scale (VAS). Results: All 3 doses of dasotraline were not significantly different when compared to placebo on the primary (Drug Liking VAS) and most secondary endpoints. Methylphenidate significantly increased Drug Liking (VAS Emax, p < 0.001), supporting the validity of the study and sensitivity of the measures for detecting abuse-related effects. The 8mg and 16mg doses of dasotraline were associated with a similar incidence of adverse events (AEs) as placebo. A greater number of AEs and negative subjective effects (VAS Emin, p < 0.004 vs. placebo) were observed at 36mg dasotraline. Among potentially abuse-related AEs, incidence with dasotraline was lower than with methylphenidate. Conclusions: These results suggest that dasotraline has minimal abuse potential and is unlikely to be recreationally abused. Dasotraline is an investigational agent being evaluated for the treatment of ADHD, which presents a novel pharmacologic and pharmacokinetic profile.




K.S., K., S.S., H., K., S., N., S., N., L.-C., K., S., & A., L. (2015). Assessment of human abuse potential of dasotraline compared to methylphenidate and placebo in recreational stimulant users. Drug and Alcohol Dependence, 156, e115. https://doi.org/10.1016/j.drugalcdep.2015.07.319 LK  - http://rug.on.worldcat.org/atoztitles/link/?sid=EMBASE&issn=03768716&id=doi:10.1016%2Fj.drugalcdep.2015.07.319&atitle=Assessment+of+human+abuse+potential+of+dasotraline+compared+to+methylphenidate+and+placebo+in+recreational+stimulant+users&stitle=Drug+Alcohol+Depend.&title=Drug+and+Alcohol+Dependence&volume=156&issue=&spage=e115&epage=&aulast=Koblan&aufirst=Kenneth+S.&auinit=K.S.&aufull=Koblan+K.S.&coden=&isbn=&pages=e115-&date=2015&auinit1=K&auinitm=S

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