Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
Condition: Social Anxiety in Autistic Adults
MeSH terms: Anxiety Disorders; Autistic Disorder
Intervention: Placebo; Midomafetamine; Therapy
Intervention description: 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.; Participants receive a capsule of 75 or 100 mg during the first of two experimental sessions and a capsule of 100 or 125 mg MDMA during the second experimental session.; 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.
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: MDMA; autism; social anxiety

Summary:

      This double-blind, randomized, placebo-controlled exploratory pilot study assessed the safety
      and feasibility of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for social
      anxiety in MDMA-naïve adults on the autism spectrum. Each of the 12 subjects participated in
      two blinded experimental sessions, assisted by either MDMA (75 mg to 125 mg) 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.

      Subjects assigned to the MDMA group received two of three different doses, either 75 mg, 100
      mg, or 125 mg MDMA. Overall, eight subjects were randomized to the MDMA group and four
      subjects were randomized to the placebo group. Observations before, during, and after
      experimental sessions were compared between these groups.

      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. The primary outcome measure was change in social anxiety symptoms as
      measured by the Liebowitz Social Anxiety Scale (LSAS) [Heimberg et al., 1999].
    

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.