Trial Outcomes & Findings for Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults (NCT NCT02008396)
NCT ID: NCT02008396
Last Updated: 2025-06-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
1-Month Post Experimental Session 2
Results posted on
2025-06-05
Participant Flow
Subjects were recruited by printed or internet advertisements, referrals from other health-care practitioners, and word-of-mouth. Potential participants were people, aged 21 or older, with a confirmed diagnosis of autism. The study was conducted at Los Angeles Biomedical Research Institute in Torrance, CA between February 2014 and October 2017.
One participant was excluded for not meeting eligibility criteria within exclusion window for enrollment.
Participant milestones
| Measure |
Inactive Placebo With Psychotherapy
Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
|
Group 1: MDMA-assisted Therapy 75mg/100mg
Participants will receive 75 mg midomafetamine HCl during their first MDMA-assisted therapy session and 100 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Group 2: MDMA-assisted Therapy 100mg/125mg
Participants will receive 100 mg midomafetamine HCl during their first MDMA-assisted therapy session and 125 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
|---|---|---|---|
|
Stage 1
STARTED
|
4
|
4
|
4
|
|
Stage 1
COMPLETED
|
3
|
4
|
4
|
|
Stage 1
NOT COMPLETED
|
1
|
0
|
0
|
|
Stage 2
STARTED
|
3
|
0
|
0
|
|
Stage 2
COMPLETED
|
3
|
0
|
0
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
Baseline characteristics by cohort
| Measure |
Inactive Placebo With Psychotherapy
n=4 Participants
Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
|
Group 1 MDMA-assisted Therapy 75mg/100mg
n=4 Participants
Participants will receive 75 mg midomafetamine HCl during their first MDMA-assisted therapy session and 100 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Group 2 MDMA-assisted Therapy 100mg/125mg
n=4 Participants
Participants will receive 100 mg midomafetamine HCl during their first MDMA-assisted therapy session and 125 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.27 years
STANDARD_DEVIATION 3.77 • n=39 Participants
|
37.93 years
STANDARD_DEVIATION 12.25 • n=41 Participants
|
27.77 years
STANDARD_DEVIATION 5.87 • n=35 Participants
|
31.32 years
STANDARD_DEVIATION 8.83 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Baseline Liebowitz Social Anxiety Scale (LSAS) Score
|
83.3 units on a scale
STANDARD_DEVIATION 11.87 • n=39 Participants
|
89.0 units on a scale
STANDARD_DEVIATION 8.60 • n=41 Participants
|
94.5 units on a scale
STANDARD_DEVIATION 22.13 • n=35 Participants
|
88.9 units on a scale
STANDARD_DEVIATION 14.67 • n=31 Participants
|
PRIMARY outcome
Timeframe: 1-Month Post Experimental Session 2Population: Safety Set
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.
Outcome measures
| Measure |
Group 1: MDMA-assisted Therapy 75mg/100mg
n=4 Participants
Participants will receive 75 mg midomafetamine HCl during their first MDMA-assisted therapy session and 100 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Group 2: MDMA-assisted Therapy 100mg/125 mg
n=4 Participants
Participants will receive 100 mg midomafetamine HCl during their first MDMA-assisted therapy session and 125 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Inactive Placebo With Psychotherapy
n=3 Participants
Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
|
|---|---|---|---|
|
Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2
|
34.3 score on a scale
Standard Deviation 10.41
|
55.5 score on a scale
Standard Deviation 11.47
|
64.0 score on a scale
Standard Deviation 13.34
|
PRIMARY outcome
Timeframe: Baseline to 1-Month Post Experimental Session 2Population: Safety Set
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.
Outcome measures
| Measure |
Group 1: MDMA-assisted Therapy 75mg/100mg
n=4 Participants
Participants will receive 75 mg midomafetamine HCl during their first MDMA-assisted therapy session and 100 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Group 2: MDMA-assisted Therapy 100mg/125 mg
n=4 Participants
Participants will receive 100 mg midomafetamine HCl during their first MDMA-assisted therapy session and 125 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Inactive Placebo With Psychotherapy
n=3 Participants
Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
|
|---|---|---|---|
|
Change in Leibowitz Social Anxiety Scale (LSAS) Total Score From Baseline to 1-Month Post Experimental Session 2
|
-51.0 score on a scale
Standard Deviation 8.19
|
-39.0 score on a scale
Standard Deviation 17.57
|
-19.3 score on a scale
Standard Deviation 18.77
|
Adverse Events
Group 1: MDMA-assisted Therapy 75mg/100mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2: MDMA-assisted Therapy 100mg/125mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Inactive Placebo With Psychotherapy (Stage 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: MDMA-assisted Therapy 75mg/100mg
n=4 participants at risk
Participants will receive 75 mg midomafetamine HCl during their first MDMA-assisted therapy session and 100 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Group 2: MDMA-assisted Therapy 100mg/125mg
n=4 participants at risk
Participants will receive 100 mg midomafetamine HCl during their first MDMA-assisted therapy session and 125 mg midomafetamine HCl during their second MDMA-assisted therapy session.
|
Inactive Placebo With Psychotherapy (Stage 1)
n=4 participants at risk
Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Psychiatric disorders
Suicidal ideation
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
General disorders
Pain
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
General disorders
Pyrexia
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Injury, poisoning and procedural complications
Retinal injury
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
50.0%
2/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Psychiatric disorders
Panic reaction
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
25.0%
1/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
0.00%
0/4 • All AEs from baseline to the end of stage 2 (approximately 10 months)
Subjects counted once per event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60