Social Anxiety in Autistic AdultsPhase 2NCT02008396
Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
A Phase 2 study testing Midomafetamine HCl and Therapy in people with Social Anxiety in Autistic Adults, run by Resilient Pharmaceuticals at 1 site in United States.
Trial 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?… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Social Anxiety in Autistic Adults
- What is being tested?
- Midomafetamine HCl and Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2014to 28 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: A Placebo-controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
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:
Read more
- 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.
Read the 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
- Being tested
- Placebo, Midomafetamine HCl, Therapy
- Keywords
- MDMA, autism, social anxiety
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Inactive 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.
Midomafetamine HClDrug
Also called 3,4-methylenedioxymethamphetamine, MDMA
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.
TherapyBehavioural
Also called Manualized 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.
| Study group | Role | What they receive |
|---|---|---|
| Inactive Placebo with Therapy | Placebo comparator | Participants will receive inactive placebo during two psychotherapy sessions lasting approximately 7 hours. Receives: Drug: Placebo; Behavioral: Therapy |
| Group 1: MDMA-assisted therapy 75 mg/100mg | Experimental | Participants will receive 75 mg and 100 mg midomafetamine HCl during two sessions of MDMA-assisted therapy, respectively, lasting approximately 7 hours. Receives: Drug: Midomafetamine HCl; Behavioral: Therapy |
| Group 2: MDMA-assisted therapy 100 mg/125 mg | Experimental | Participants will receive 100 mg and 125 mg midomafetamine HCl during two sessions of MDMA-assisted therapy, respectively, lasting approximately 7 hours. Receives: Drug: Midomafetamine HCl; Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2
The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. The higher the score, the greater the anxiety symptoms. The overall scores are interpreted as: 55-65 is moderate, 65-80 is marked, 80-95 is severe, and greater than 95 is very severe social anxiety symptoms.
Measured: 1-Month Post Experimental Session 2
Change in Leibowitz Social Anxiety Scale (LSAS) Total Score From Baseline to 1-Month Post Experimental Session 2
The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. The higher the score, the greater the anxiety symptoms. The overall scores are interpreted as: 55-65 is moderate, 65-80 is marked, 80-95 is severe, and greater than 95 is very severe social anxiety symptoms.
Measured: Baseline to 1-Month Post Experimental Session 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start11 Apr 2014
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety in Autistic AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Responsible party
- Sponsor
- Investigators
- Charles S. Grob, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008396
- Sponsor's protocol ID
- MAA-1
- Status last verified
- May 2025
- First submitted
- 6 Dec 2013
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will share outcome data appearing in any published reports upon request.
Publications
Heimberg RG, Horner KJ, Juster HR, Safren SA, Brown EJ, Schneier FR, Liebowitz MR. Psychometric properties of the Liebowitz Social Anxiety Scale. Psychol Med. 1999 Jan;29(1):199-212. doi: 10.1017/s0033291798007879.
PubMed 10077308Danforth AL, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, Yazar-Klosinski B, Emerson A. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology (Berl). 2018 Nov;235(11):3137-3148. doi: 10.1007/s00213-018-5010-9. Epub 2018 Sep 8.
PubMed 30196397Danforth AL, Struble CM, Yazar-Klosinski B, Grob CS. MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:237-49. doi: 10.1016/j.pnpbp.2015.03.011. Epub 2015 Mar 25.
PubMed 25818246
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
- ClinicalTrials.gov ID
- NCT02008396
- Acronym / sponsor ID
- MAA-1
- Conditions
- Social Anxiety in Autistic Adults
- Keywords
- MDMA, autism, social anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Study start
- 11 Apr 2014 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactive Placebo with Therapy | Placebo comparator | Drug: Placebo, Behavioral: TherapyParticipants will receive inactive placebo during two psychotherapy sessions lasting approximately 7 hours. |
| Group 1: MDMA-assisted therapy 75 mg/100mg | Experimental | Drug: Midomafetamine HCl, Behavioral: TherapyParticipants will receive 75 mg and 100 mg midomafetamine HCl during two sessions of MDMA-assisted therapy, respectively, lasting approximately 7 hours. |
| Group 2: MDMA-assisted therapy 100 mg/125 mg | Experimental | Drug: Midomafetamine HCl, Behavioral: TherapyParticipants will receive 100 mg and 125 mg midomafetamine HCl during two sessions of MDMA-assisted therapy, respectively, lasting approximately 7 hours. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Inactive placeboSubjects 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 | Inactive Placebo with Therapy |
| Midomafetamine HClAlso: 3,4-methylenedioxymethamphetamine, MDMAParticipants 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. | Drug | Group 1: MDMA-assisted therapy 75 mg/100mg, Group 2: MDMA-assisted therapy 100 mg/125 mg |
| TherapyAlso: Manualized therapyTherapy 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. | Behavioural | Group 1: MDMA-assisted therapy 75 mg/100mg, Group 2: MDMA-assisted therapy 100 mg/125 mg, Inactive Placebo with Therapy |
Primary outcome
Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2
Time frame: 1-Month Post Experimental Session 2
The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. The higher the score, the greater the anxiety symptoms. The overall scores are interpreted as: 55-65 is moderate, 65-80 is marked, 80-95 is severe, and greater than 95 is very severe social anxiety symptoms.
Change in Leibowitz Social Anxiety Scale (LSAS) Total Score From Baseline to 1-Month Post Experimental Session 2
Time frame: Baseline to 1-Month Post Experimental Session 2
The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. The higher the score, the greater the anxiety symptoms. The overall scores are interpreted as: 55-65 is moderate, 65-80 is marked, 80-95 is severe, and greater than 95 is very severe social anxiety symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10077308Heimberg RG, Horner KJ, Juster HR, Safren SA, Brown EJ, Schneier FR, Liebowitz MR. Psychometric properties of the Liebowitz Social Anxiety Scale. Psychol Med. 1999 Jan;29(1):199-212. doi: 10.1017/s0033291798007879.
- Results publication: PubMed 30196397Danforth AL, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, Yazar-Klosinski B, Emerson A. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology (Berl). 2018 Nov;235(11):3137-3148. doi: 10.1007/s00213-018-5010-9. Epub 2018 Sep 8.
- Derived from this study: PubMed 25818246Danforth AL, Struble CM, Yazar-Klosinski B, Grob CS. MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:237-49. doi: 10.1016/j.pnpbp.2015.03.011. Epub 2015 Mar 25.
- Link to open access copy of publication on studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share outcome data appearing in any published reports upon request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles S. Grob, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midomafetamine HCl and Therapy in people with Social Anxiety in Autistic Adults, run by Resilient Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2 (time frame: 1-Month Post Experimental Session 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02008396, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.