NCT02008396

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

A Placebo-controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Lykos Therapeutics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing social anxiety in adults with autism. The main questions it aims to answer are: * Do two sessions of MDMA-assisted therapy reduce social anxiety? * What dose of MDMA is most effective at reducing social anxiety? Researchers will compare two blinded sessions of MDMA-assisted therapy to two blinded sessions of placebo with therapy. Participants will undergo three non-drug preparatory therapy sessions before the first blinded medication session. After each medication session, participants will undergo three non-drug integrative therapy sessions. In Stage 2, participants who received placebo with therapy in the first two blinded sessions will be able to undergo two sessions with MDMA-assisted therapy.

Detailed description

The main objective of this study was to collect safety data to examine whether MDMA-assisted therapy was tolerated and to estimate symptom reduction in social anxiety and other psychiatric symptoms that are common in the adult autistic population as evaluated by standard clinical measures. The primary outcome measure was change in social anxiety symptoms as measured by the Liebowitz Social Anxiety Scale (LSAS) \[Heimberg et al., 1999\]. Each of the 12 subjects participated in two blinded experimental sessions, with either MDMA or placebo, which lasted seven hours. Before experimental sessions, participants underwent three separate hour-long preparatory sessions to learn what to expect and complete pre-treatment assignments. After each experimental session, participants underwent three separate hour-long integrative sessions to help integrate their experiences and insights from the experimental sessions. This study was designed as a dose escalation study to assist with the exploration of safety and finding the most effective dose in this population. Upon enrollment, participants (Group 1) were randomized to receive one dose of either placebo or 75 mg of midomafetamine HCl. In the second experimental session one month later, Group 1 subjects randomized to MDMA escalated to 100 mg of midomafetamine HCl, unless contraindicated. The second group of subjects enrolled (Group 2) were randomized to receive one dose of either placebo or 100 mg of midomafetamine HCl. In the second experimental session one month later, Group 2 subjects randomized to MDMA escalated to 125 mg of midomafetamine HCl, unless contraindicated. The blind was maintained through the six-month follow-up. In Stage 2 after the blind was broken, subjects who received placebo in Stage 1 were offered an open-label extension with two experimental sessions of MDMA-assisted therapy scheduled one month apart. Subjects received 75 mg of midomafetamine HCl in the first session and escalated to 125 mg of midomafetamine HCl in the second session, unless contraindicated.

Conditions

• Social Anxiety in Autistic Adults

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-04-11
• Primary completion: 2017-04-28
• Completion: 2017-04-28
• First posted: 2013-12-11
• Last updated: 2025-06-05
• Results posted: 2020-10-14

Locations

1 site across 1 country: United States