Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
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.
Detailed Description
Randomized, triple-masked, parallel-group Phase II pilot (n=12) comparing two blinded MDMA-assisted therapy sessions to two blinded placebo-with-therapy sessions in autistic adults with social anxiety; therapy included three 1-h preparatory sessions and three 1-h integrative sessions after each experimental session.
Dose-escalation design: Group 1 received 75 mg then 100 mg; Group 2 received 100 mg then 125 mg; placebo arm received lactose capsules identical in appearance. Primary outcome: change in LSAS social anxiety score; safety/tolerability assessed throughout and blind maintained through six-month follow-up.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Placebo + Therapy
inactiveInactive lactose placebo capsules administered with manualised/nondirective therapy in two blinded 7-hour sessions.
Interventions
- Placebovia Oral• two sessions• 2 doses total
Lactose capsules identical in appearance to MDMA; given during each experimental session.
- Compoundvia Other• throughout sessions
Manualised, largely nondirective psychotherapy: three 1-h preparatory sessions and three 1-h integrative sessions per experimental session.
Group 1 MDMA
experimentalMDMA-assisted therapy with dose escalation: 75 mg in session 1, 100 mg in session 2 (unless contraindicated).
Interventions
- MDMA75 - 100 mgvia Oral• two sessions• 2 doses total
Session 1: 75 mg; Session 2 (~1 month later): 100 mg if tolerated.
- Compoundvia Other• throughout sessions
Therapy as per manualised nondirective approach; preparatory and integrative sessions included.
Group 2 MDMA
experimentalMDMA-assisted therapy with dose escalation: 100 mg in session 1, 125 mg in session 2 (unless contraindicated).
Interventions
- MDMA100 - 125 mgvia Oral• two sessions• 2 doses total
Session 1: 100 mg; Session 2 (~1 month later): 125 mg if tolerated.
- Compoundvia Other• throughout sessions
Therapy as per manualised nondirective approach; preparatory and integrative sessions included.
Participants
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.
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Placebo + Therapyinactive | 4 | — | — | 0(0.0%) | 0(0.0%) |
| Group 1 MDMAexperimental | 8 | — | 1(12.5%) | 0(0.0%) | 1(12.5%) |
| Group 2 MDMAexperimental | — | — | — | — | — |
* Table 4 reports expected reactions; Table 5 reports psychiatric TEAEs. No SAEs reported.
* One participant discontinued due to not meeting inclusion criteria. One severe reaction (headache) reported. Psychiatric TEAEs (Table 5) include anxiety, depressed mood, depression, panic attack, panic reaction, and suicidal ideation. Note: 1 participant in MDMA group was excluded from analysis due to medical history but included in ITT.
* ArmKey 'arm3' not found in paper; only Placebo and MDMA groups were reported.
Study Details
- StatusCompleted
- PhasePhase II
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment12 participants
- TimelineStart: 2014-01-02End: 2017-01-08
- Compounds
- Topic