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 : November 3, 2020
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | December 6, 2013 | ||||||||||||
First Posted Date ICMJE | December 11, 2013 | ||||||||||||
Results First Submitted Date ICMJE | September 18, 2020 | ||||||||||||
Results First Posted Date ICMJE | October 14, 2020 | ||||||||||||
Last Update Posted Date | November 3, 2020 | ||||||||||||
Study Start Date ICMJE | February 2014 | ||||||||||||
Actual Primary Completion Date | August 2017 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Change in Lieberman Social Anxiety Scale score [ Time Frame: Baseline, one day post-drug, 2 weeks post-drug, one month post-drug, 6 months post-drug ] Semi-structured interview assessing social anxiety symtoms
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Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||||||||
Brief Title ICMJE | Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults | ||||||||||||
Official Title ICMJE | A Placebo-controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults | ||||||||||||
Brief Summary | 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. Each of the 12 subjects participated in two blinded experimental sessions, assisted by either MDMA (75 mg to 125 mg) 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. Subjects assigned to the MDMA group received two of three different doses, either 75 mg, 100 mg, or 125 mg MDMA. Overall, eight subjects were randomized to the MDMA group and four subjects were randomized to the placebo group. Observations before, during, and after experimental sessions were compared between these groups. 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. The primary outcome measure was change in social anxiety symptoms as measured by the Liebowitz Social Anxiety Scale (LSAS) [Heimberg et al., 1999]. |
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Detailed Description | Studies suggest that autistic adults are at greater risk for social anxiety. Social anxiety is a condition characterized by fear of scrutiny and avoidance of social interactions. Social anxiety frequently compounds the considerable social challenges experienced by autistic adults. There are currently no FDA-approved pharmacologic treatments for autistic adults, although off-label prescription of selective serotonin reuptake inhibitors (SSRIs) are on the rise in this population. Based on the known effects of MDMA, as well as individual reports from autistic adults, this exploratory study focused on enhancing functional skills in this underserved population, who tend to experience greater anxiety, depression and victimization than typically developing 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. 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, assisted by 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, the first six subjects (Group 1) was randomized to receive one dose of either placebo (N=2) or 75 mg of MDMA (N=4). In the second experimental session one month later, Group 1 subjects randomized to MDMA escalated to 100 mg of MDMA, unless contraindicated. The second six subjects enrolled (Group 2) were randomized to receive one dose of either placebo (N=2) or 100 mg of MDMA (N=4). In the second experimental session one month later, Group 2 subjects randomized to MDMA escalated to 125 mg of MDMA, 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 scheduled one month apart. Subjects received 75 mg of MDMA in the first session and escalated to 125 mg of MDMA in the second session, unless contraindicated. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Social Anxiety in Autistic Adults | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE |
12 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Actual Study Completion Date ICMJE | August 2017 | ||||||||||||
Actual Primary Completion Date | August 2017 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT02008396 | ||||||||||||
Other Study ID Numbers ICMJE | MAA-1 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Multidisciplinary Association for Psychedelic Studies | ||||||||||||
Study Sponsor ICMJE | Multidisciplinary Association for Psychedelic Studies | ||||||||||||
Collaborators ICMJE | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||||||||||
Investigators ICMJE |
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PRS Account | Multidisciplinary Association for Psychedelic Studies | ||||||||||||
Verification Date | June 2019 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |