Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
Sponsored by Lykos Therapeutics
About This Study
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.
Conditions Studied
Interventions
- •Placebo
- •Midomafetamine HCl
- •Therapy
Eligibility
View full eligibility criteria
Inclusion Criteria: * Have a diagnosis of Autism Spectrum Disorder. * Have social anxiety. * Are at least 21 years old. * Have completed two years of college-level education or comparable vocational training. * Are willing to refrain from psychiatric medication for at least 5 half-lives plus a week prior to experimental session. * Agree to follow all study-related instructions and restrictions, including restrictions on food, alcohol and caffeine consumption prior to experimental sessions. * Are willing to commit to preparatory sessions, medication management, experimental sessions, follow-up sessions and to complete evaluation instruments. * Agree not to use MDMA/ecstasy outside of study sessions during the study, including the follow up period. * Are willing to be contacted on a daily basis for a week after each experimental session. * Are willing to provide a contact that is willing and able to be reached by investigators, accompany the subject during some or all of the study visits, and complete study measures. * Are willing to give blood samples. * Are proficient in speaking and reading English. Subjects communicating with text-to-speech technology will also be permitted to enroll. Exclusion Criteria: * Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study. * Are abusing illegal drugs. * Are not able to give adequate informed consent. * Are not able to attend face-to-face visits or those who plan to move out of the area within the treatment period. * Are pregnant or nursing, or if are able to bear children and do not practice an effective means of birth control.