29
Participants
Start Date
May 13, 2013
Primary Completion Date
December 3, 2015
Study Completion Date
February 1, 2017
Comparator Dose (40mg) MDMA HCl
An initial comparator-dose of 40 mg midomafetamine HCl orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (20 mg).
Active Dose 2 (100 mg) MDMA HCl
An initial dose of full-dose 100 mg midomafetamine HCl orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (50 mg).
Active Dose 1 (125 mg) MDMA HCl
An initial dose of full-dose 125 mg midomafetamine HCl orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (62.5 mg).
Psychotherapy
Non-directive manualized therapy
Offices of Marcela d'Otalora, Boulder
Lead Sponsor
Lykos Therapeutics
INDUSTRY