NCT01689740 - Randomized, Double-blind, Placebo-Controlled Pilot Study of MDMA-assisted Therapy for PTSD | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 17, 2013

Primary Completion Date

April 7, 2016

Study Completion Date

July 16, 2017

Conditions

Posttraumatic Stress Disorder (PTSD)

Interventions

DRUG

Active Placebo Dose MDMA-assisted therapy (25 mg)

Initial dose of 25 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 12.5 mg 1.5 to 2.5 hours later.

DRUG

Full Dose MDMA-assisted therapy (125 mg)

Initial dose of 125 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg 1.5 to 2.5 hours later.

DRUG

Open-Label Full Dose MDMA-assisted therapy (125 mg)

Initial dose of 125 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg 1.5 to 2.5 hours later.

BEHAVIORAL

Psychotherapy

Non-directive psychotherapy will be conducted throughout the study.

Trial Locations (1)

70350

Beer Yaakov Hospital, Be’er Ya‘aqov