"Evaluation of MDMA on Startle Response

This is a randomized, blinded, placebo-controlled Phase 1 study that aims to evaluate the
impact of 3,4-methylenedioxymethamphetamine (MDMA) on startle response . MDMA is an
experimental drug and is illegal to possess outside of research; when sold illegally it is
referred to as Ecstasy or Molly (material supposedly containing MDMA). MDMA may make it
easier to face unpleasant memories and reduce anxiety.

This study will enroll healthy participants. At visit 1 all participants will undergo a
1-hour startle test. Acoustic startle will be measured through assessing eye-blink response
from the orbicularis oculi muscles in response to a 106 dB noise, using sensors under the
eye. While watching the computer monitor, the participant will also experience several brief
blasts of air directed at the throat. At visit 2, 24 hours later, participants will be
randomized to receive 100 mg of MDMA or inactive placebo, after which they will undergo
another startle task. The researchers will measure pulse, blood pressure and temperature once
before and six times after receiving MDMA or placebo, and study participants will complete a
questionnaire about their experience. At visit 3, participants will return for a final
startle test and recall task. Sleep will be measured via self-report and Fittbit during study
participation.

The primary objective of this study is to assess whether MDMA affects startle response

Inclusion Criteria:

- Persons aged 21 to 55.

- Ability to visually read and understand English language.

- Live within in metro Atlanta area

- Previously used MDMA in a recreational or research setting

- If a person is of childbearing potential (able to bear children), they must have a
negative pregnancy test at study entry and prior to the Experimental Session. They
must agree to use adequate birth control through 10 days after the last dose of MDMA.
Adequate birth control methods include intrauterine device (IUD), injected or
implanted hormonal methods, abstinence, oral hormones plus a barrier contraception or
double barrier contraception. Two forms of contraception are required with any barrier
method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus
spermicide, oral hormonal contraceptives plus spermicide or condom). Not of
childbearing potential is defined as permanent sterilization, postmenopausal, or male.

Exclusion Criteria:

- Upon review of medical or psychiatric history, have any current or past diagnosis that
would be considered a risk to participating in the study.

- Are abusing illegal drugs.

- Current use of any psychoactive medications, including antidepressants, mood
stabilizers, sedatives, stimulants, antipsychotics, anxiolytics, or beta-blockers

- Are not able to give adequate informed consent.

- Uncontrolled hypertension, or clinically significant cardiac arrhythmia, as detected
by electrocardiogram.

- Currently pregnant or breast-feeding.

- History of acute angle glaucoma.

- Hearing impairment as assessed by audiometer; unable to detect tones below 40 dB in
right or left ear.