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Trial record 1 of 1 for:    mdma social anxiety
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MDMA-assisted Therapy for Social Anxiety in Autistic Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02008396
First Posted: December 11, 2013
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Los Angeles Biomedical Research Institute
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
  Purpose
This randomized, double-blind study is intended to test the safety and feasibility of using 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy, compared with placebo, to treat social anxiety in autistic adults. Subjects will be randomly (by chance) assigned to receive placebo or MDMA during two experimental sessions. The first six subjects in the study will be randomized to placebo (2) or 75 mg MDMA on the first session and 100 mg MDMA on the second session (4). The next six subjects will be randomized to placebo (2) or 100 mg MDMA on the first session and 125 mg MDMA on the second session (4). The study will explore whether two doses of MDMA, combined with selected therapeutic activities, can reduce social anxiety. The study takes place in Los Angeles, California and requires about 15 visits to the study location over several months. Study subjects will meet with the investigators three times to prepare for the MDMA sessions, and they will meet with them on three occasions and receive daily phone calls for safety monitoring for a week after each session. Blood samples will be collected at baseline, two hours after drug administration during the second experimental session, one month and six months after the second experimental session to measure amounts of the hormones oxytocin, arginine vasopressin and cortisol in plasma. Subjects will return six months after their second experimental session for measurements of and social anxiety and other symptoms and an interview. Subjects will learn what they received at this visit. Subjects who received placebo can go through treatment again to have two sessions with MDMA, the first with 75 mg and the second with 125mg MDMA. Social anxiety, anxiety, depression, stress, self-esteem, empathy, and quality of life will be measured before and after experimental sessions.

Condition Intervention Phase
Social Anxiety in Autistic Adults Drug: Placebo Drug: MDMA Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

Resource links provided by NLM:


Further study details as provided by Multidisciplinary Association for Psychedelic Studies:

Primary Outcome Measures:
  • Change in Lieberman Social Anxiety Scale score [ Time Frame: Baseline, one day post-drug, 2 weeks post-drug, one month post-drug, 6 month follow-up ]
    Semi-structured interview assessing social anxiety symptoms


Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: Pre-drug, one day post-drug, 2 weeks post-drug, one month post-drug, monthly 1-5 months post-drug, 6 month follow-up ]
    Self-report measure of symptoms of depression

  • State Trait Anxiety Inventory (STAI) [ Time Frame: Pre-drug, one day post-drug, 2 weeks post-drug, one month post-drug, monthly 1-5 months post-drug, 6 month follow-up ]
    Self-report measure of symptoms of current and general anxiety

  • Perceived Stress Scale (PSS) [ Time Frame: Pre-drug, one day post-drug, two weeks post-drug, one month post-drug, monthly by mail (1-5 months post drug), 6 month follow-up ]
    Self-report measure of experiencing stress

  • Interpersonal Reactivity Index (IRI) [ Time Frame: Pre-drug, one day post-drug, one month post-drug, 6 month follow-up ]
    Self-report measure of empathy

  • Rosenberg Self-Esteem Scale (RSES) [ Time Frame: Pre-drug, one day post-drug, one month post-drug, monthly by mail (1-5 months post drug), 6 month follow-up ]
    Self-report measure of self-esteem

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline ]
    Interviewer-administered measure of suicidal thinking (ideation) and behavior

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Average (given every face to face visit from pre-drug to 6 month follow up) ]
    Interviewer-administered measure of suicidal thinking (ideation) and behavior

  • The Awareness of Social Inference Test [ Time Frame: Pre-drug, experimental session 1, experimental session 2, one month post-drug, 6 month follow-up ]
    Assessment of social perception

  • Quality of Life Questionnaire [ Time Frame: Pre-drug, 6 month follow-up ]
    Self-reported measure of quality of life

  • Emotion Regulation Questionnaire [ Time Frame: Pre-drug, one month after second drug session, 6-month follow-up ]
    Self-reported measure of emotion regulation

  • Toronto Alexithymia Scale (TAS-20) [ Time Frame: Pre-drug, one month after second drug session, 6-month follow-up ]
    Self-report measure of trouble naming one's own emotions (alexithymia)

  • Peak systolic blood pressure [ Time Frame: Experimental session 1 ]
    Highest SBP reading taken from hourly readings during experimental sessions (Stage 1(

  • Peak diastolic blood pressure (DBP) [ Time Frame: Experimental session 1 ]
    Highest DBP reading taken from hourly readings during experimental sessions (Stage 1)

  • Peak heart rate (HR) [ Time Frame: Experimental session 1 ]
    Highest HR reading taken from hourly readings during experimental sessions (Stage 1).

  • Peak body temperature (BT) [ Time Frame: Experimental session 1 ]
    Highest BT reading taken from hourly readings during experimental sessions.

  • Average systolic blood pressure [ Time Frame: Experimental session 1 ]
    Average SBP reading taken from hourly readings during Experimental Session 1

  • Average diastolic blood pressure (DBP) [ Time Frame: Experimental session 1 ]
    Average DBP reading taken from hourly readings during experimental session 1.

  • Average heart rate (HR) [ Time Frame: Experimental session 1 ]
    Average HR reading taken from hourly readings during experimental session 1.

  • Average body temperature (BT) [ Time Frame: Experimental session 1 ]
    Average BT reading taken from hourly readings during experimental session 1.

  • Peak systolic blood pressure [ Time Frame: Experimental session 2 ]
    Highest SBP reading taken from hourly readings during experimental sessions (Stage 1(

  • Peak diastolic blood pressure (DBP) [ Time Frame: Experimental session 2 ]
    Highest DBP reading taken from hourly readings during experimental sessions (Stage 1)

  • Peak heart rate (HR) [ Time Frame: Experimental session 2 ]
    Highest HR reading taken from hourly readings during experimental sessions (Stage 1).

  • Peak body temperature (BT) [ Time Frame: Experimental session 2 ]
    Highest BT reading taken from hourly readings during experimental sessions.

  • Average systolic blood pressure [ Time Frame: Experimental session 2 ]
    Average SBP reading taken from hourly readings during Experimental Session 2

  • Average diastolic blood pressure (DBP) [ Time Frame: Experimental session 2 ]
    Average DBP reading taken from hourly readings during experimental session 2.

  • Average heart rate (HR) [ Time Frame: Experimental session 2 ]
    Average HR reading taken from hourly readings during experimental session 1.

  • Average body temperature (BT) [ Time Frame: Experimental session 2 ]
    Average BT reading taken from hourly readings during experimental session 2.


Other Outcome Measures:
  • Blood oxytocin levels [ Time Frame: Pre-drug, 2 h post-drug during second experimental session, 2 weeks post-drug, one month post-drug, 2 h post-drug in both Stage 2 sessions if enrolled in Stage 2, 6 month follow up ]
    Measures level of oxytocin released after MDMA or placebo

  • Blood arginine vasopressin (AVP) levels [ Time Frame: Pre-drug, 2 h post-drug in second experimental session, 2 weeks post-drug, one month post-drug, 2 h post-drug after both Stage 2 experimental sessions if enrolled in stage 2, 6 month follow-up ]
    Measures level of oxytocin released after MDMA or placebo

  • Blood cortisol levels [ Time Frame: Pre-drug, 2 h post-drug during 2nd experimental session, 2 weeks post-drug, one month post-drug, 2 h post-drug on both Stage 2 experimental sessions if enrolled in Stage 2, 6 month follow-up ]
    Measures level of oxytocin released after MDMA or placebo

  • Autism Diagnostic Observation Schedule - 2 (ADOS-2) [ Time Frame: Baseline ]
    Diagnostic measure for autism, used in part to determine eligibility for enrollment


Enrollment: 12
Study Start Date: February 2014
Study Completion Date: August 2017
Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will receive inactive placebo in two sessions
Drug: 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 therapeutic activities during experimental sessions .
Other Name: Inactive placebo
Experimental: MDMA
Participants will receive 75 to 125 mg during two sessions; first session dose lower than second session dose.
Drug: MDMA
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 on the second of two experimental sessions. They will receive MDMA along with selected therapeutic activities during each experimental session.
Other Name: 3,4-methylenedioxymethamphetamine, MDMA

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of Autism Spectrum Disorder
  • Have at least moderate social anxiety (LSAS score =>60)
  • MDMA-naive (no past use of MDMA/ecstasy)
  • Are at least 21 years old
  • Have completed two years of college-level education or comparable vocational training
  • 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
  • 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
  • Willing to be contacted on a daily basis for a week after each experimental session
  • willing to provide a contact willing and able to be reached by investigators, accompany the subject during some or all of the study visits, and complete study measures
  • 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 a woman who can have children, those who are not practicing an effective means of birth control;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008396


Locations
United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Charles S. Grob, MD University of California, Los Angeles
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT02008396     History of Changes
Other Study ID Numbers: MAA-1
First Submitted: December 6, 2013
First Posted: December 11, 2013
Last Update Posted: August 8, 2017
Last Verified: March 2017

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
MDMA
autism
social anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Autistic Disorder
Mental Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents