Social Anxiety MDMA-Assisted Therapy Investigation (NCT05138068) | Clinical Trial Compass
CompletedPhase 2
Social Anxiety MDMA-Assisted Therapy Investigation
United States90 participantsStarted 2022-04-13
Plain-language summary
This is a randomized, open-label delayed treatment study to assess the safety and effect of MDMA-assisted therapy in treating 20 participants diagnosed with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. This study will obtain an estimate of effect size for two experimental sessions of MDMA-assisted therapy for the treatment of social anxiety disorder on measures of safety, social anxiety, functional outcomes, psychiatric symptoms, and putative mechanisms of action. The primary outcome for this study will be the Liebowitz Social Anxiety Scale (LSAS) administered by a blinded Independent Rater (IR). Other assessments, including physiological, self-report, and behavioral tasks will be used to assess other exploratory variables. An additional aim of the trial will be the development of a treatment manual for MDMA-AT for SAD for future research.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Are between the ages of 18 and 65 years old.
✓. Live in the Portland, OR area.
✓. Are fluent in speaking and reading English.
✓. Are able to swallow pills.
✓. Agree to have study visits recorded, including Experimental Sessions, assessments, and non-drug psychotherapy sessions.
✓. Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
✓. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
✓. If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
Exclusion criteria
✕. Are not able to give adequate informed consent.
What they're measuring
1
Evaluate the effect of MDMA-assisted therapy on severity of social anxiety disorder symptoms, as measured by total score on the Liebowitz Social Anxiety Scale (L-SAS).
Timeframe: Baseline, Primary outcome (2 weeks after final integration session), follow up (26-weeks after primary outcome)
✕. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of SAD or any other psychiatric disorder.
✕. Are likely, in the investigator's opinion and via observation during the Preparatory Period, to lack social support or lack a stable living situation or supportive family/network.
✕. Have any current problem which, in the opinion of the investigator or Study Physician, might interfere with participation.
✕. Would present a serious risk to others as assessed by investigator, Study Physician, or study team.
✕. Require certain excluded medications.
✕. Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
✕. Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 millimeters of Mercury \[mmHg\] or higher assessed on three separate occasions).