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Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

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ClinicalTrials.gov Identifier: NCT02008396
Recruitment Status : Completed
First Posted : December 11, 2013
Results First Posted : October 14, 2020
Last Update Posted : June 22, 2021
Sponsor:
Collaborator:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Social Anxiety in Autistic Adults
Interventions Drug: Placebo
Drug: 75 mg to 125 mg MDMA
Behavioral: Psychotherapy
Enrollment 12
Recruitment Details 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.
Pre-assignment Details One participant was excluded for not meeting eligibility criteria within exclusion window for enrollment.
Arm/Group Title Inactive Placebo With Psychotherapy MDMA With Psychotherapy
Hide Arm/Group Description Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours. Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
Period Title: Overall Study
Started 4 8
Completed 4 7
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Arm/Group Title Inactive Placebo With Psychotherapy 75 mg to 125 mg MDMA With Psychotherapy Total
Hide Arm/Group Description Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours. Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose. Total of all reporting groups
Overall Number of Baseline Participants 4 8 12
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
8
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
Female
0
   0.0%
2
  25.0%
2
  16.7%
Male
4
 100.0%
6
  75.0%
10
  83.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 4 participants 8 participants 12 participants
White/Caucasian
2
  50.0%
4
  50.0%
6
  50.0%
Latino/Hispanic
0
   0.0%
2
  25.0%
2
  16.7%
Hispanic & Caucasian
0
   0.0%
1
  12.5%
1
   8.3%
Asian/Pacific Islander
1
  25.0%
0
   0.0%
1
   8.3%
Asian & Caucasian
0
   0.0%
1
  12.5%
1
   8.3%
Middle Eastern
1
  25.0%
0
   0.0%
1
   8.3%
1.Primary Outcome
Title Liebowitz Social Anxiety Scale (LSAS) Total Score at Baseline
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT)
Arm/Group Title Inactive Placebo With Psychotherapy 75 mg to 125 mg MDMA With Psychotherapy
Hide Arm/Group Description:
Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
83.3  (11.9) 91.8  (15.8)
2.Primary Outcome
Title Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2
Hide Description 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.
Time Frame 1-Month Post Experimental Session 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT)
Arm/Group Title Inactive Placebo With Psychotherapy 75 mg to 125 mg MDMA With Psychotherapy
Hide Arm/Group Description:
Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
64.0  (13.3) 46.4  (15.2)
3.Primary Outcome
Title Change in Leibowitz Social Anxiety Scale (LSAS) Total Score From Baseline to 1-Month Post Experimental Session 2
Hide Description 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.
Time Frame Baseline to 1-Month Post Experimental Session 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT)
Arm/Group Title Inactive Placebo With Psychotherapy 75 mg to 125 mg MDMA With Psychotherapy
Hide Arm/Group Description:
Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours.
Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
-19.3  (18.8) -44.1  (14.8)
Time Frame Day of blinded experimental sessions, two sessions per subject.
Adverse Event Reporting Description Subjects counted once per event
 
Arm/Group Title Inactive Placebo With Psychotherapy 75 to 125 mg MDMA With Psychotherapy
Hide Arm/Group Description Subjects will receive inactive placebo during two psychotherapy sessions lasting approximately 7-8 hours. Participants will receive 75 to 125 mg during two psychotherapy sessions lasting approximately 7-8 hours; first session dose lower than second session dose.
All-Cause Mortality
Inactive Placebo With Psychotherapy 75 to 125 mg MDMA With Psychotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Inactive Placebo With Psychotherapy 75 to 125 mg MDMA With Psychotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inactive Placebo With Psychotherapy 75 to 125 mg MDMA With Psychotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)   8/8 (100.00%) 
Gastrointestinal disorders     
Lack of appetite *  1/4 (25.00%)  3/8 (37.50%) 
General disorders     
Difficulty concentrating *  1/4 (25.00%)  5/8 (62.50%) 
Fatigue *  1/4 (25.00%)  4/8 (50.00%) 
Headache *  1/4 (25.00%)  4/8 (50.00%) 
Restlessness *  1/4 (25.00%)  3/8 (37.50%) 
Drowsiness *  0/4 (0.00%)  1/8 (12.50%) 
Need more sleep *  0/4 (0.00%)  1/8 (12.50%) 
Metabolism and nutrition disorders     
Thirst *  0/4 (0.00%)  2/8 (25.00%) 
Musculoskeletal and connective tissue disorders     
Muscle tension *  1/4 (25.00%)  3/8 (37.50%) 
Weakness *  1/4 (25.00%)  1/8 (12.50%) 
Jaw clenching, tight jaw *  0/4 (0.00%)  1/8 (12.50%) 
Nervous system disorders     
Dizziness *  1/4 (25.00%)  1/8 (12.50%) 
Impaired gait/balance *  0/4 (0.00%)  1/8 (12.50%) 
Psychiatric disorders     
Anxiety *  1/4 (25.00%)  6/8 (75.00%) 
Low mood *  0/4 (0.00%)  2/8 (25.00%) 
Increased irritability *  0/4 (0.00%)  1/8 (12.50%) 
Ruminations *  0/4 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders     
Sensitivity to cold *  0/4 (0.00%)  4/8 (50.00%) 
Perspiration *  1/4 (25.00%)  1/8 (12.50%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julie B. Wang, MPH, PhD/ Senior Clinical Data Scientist
Organization: Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp.
Phone: (831) 429-6362
EMail: juliewang@mapsbcorp.com
Layout table for additonal information
Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT02008396    
Other Study ID Numbers: MAA-1
First Submitted: December 6, 2013
First Posted: December 11, 2013
Results First Submitted: September 18, 2020
Results First Posted: October 14, 2020
Last Update Posted: June 22, 2021