Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 11, 2014

Primary Completion Date

April 28, 2017

Study Completion Date

April 28, 2017

Conditions
Social Anxiety in Autistic Adults
Interventions
DRUG

Placebo

Subjects will receive capsules of lactose of identical appearance to MDMA capsules during each of two experimental sessions. Capsules will be administered along with therapy.

DRUG

Midomafetamine HCl

Participants in Group 1 receive 75 or 100 mg during the two experimental sessions and participants in Group 2 receive 100 or 125 mg during two experimental sessions.

BEHAVIORAL

Therapy

Therapy conducted throughout experimental sessions. Therapists will use a largely nondirective approach. There will be periods of structured and unstructured interactions. The structured interactions will be selected based on elements of therapeutic interventions that are currently in use in this population for the treatment of social anxiety.

Trial Locations (1)

90502

Los Angeles Biomedical Research Institute, Torrance

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

lead

Lykos Therapeutics

INDUSTRY