Evaluation of MDMA on Startle Response
Condition: Startle Response
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine how the drug methylenedioxymethamphetamine (MDMA) impacts response to
      different types of memory in humans compared to placebo. 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, and it may do so in part by influencing response to memories.
      This study will enroll healthy adults who will need to come in for three visits over four
      days. At visit 1, participants will undergo a 1-hour startle test. The startle test measures
      eye-blink response to loud sounds. After this, the participant will also view different
      colored shapes presented on a computer monitor. While watching the computer monitor, the
      participant will experience several brief blasts of air directed at the throat, while
      eye-blink is measured with sensors under the eye. The following day at visit 2, participants
      will be randomized to receive placebo or 100 mg MDMA and will complete tasks similar to the
      ones completed the previous day. Participants who agree to do so will have blood drawn to
      measure the neurohormones oxytocin and cortisol and brain-derived neurotrophic factor (BDNF)
      before and after drug administration on Visit 2. The researchers will measure pulse, blood
      pressure and temperature once before and seven times after receiving MDMA or placebo, and
      study participants will complete a questionnaire about their experience. Two days after
      receiving MDMA or placebo, participants will return for a third visit to complete similar
      tasks to previous visits. This study will also measure sleep through a sleep diary and
      actigraphy, which is a device worn on the wrist like a watch that records movement during
      sleep and lets researchers see how much sleep a person is getting.
    

Detailed description: 
      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. Participants enrolled in the study who agree to do this will have their
      blood drawn to measure levels of oxytocin, and possibly other hormones or proteins, such as
      cortisol or brain-derived neurotrophic factor (BDNF). Measuring oxytocin will be blind to
      condition, and the decision will happen before randomization to either condition. Blood will
      be drawn before MDMA or placebo administration, and eight times afterwards.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
    

Intervention name(s): Placebo; Midomafetamine; Acoustic startle
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Placebo given day after startle assessment; Participant will receive 100 mg MDMA one day after startle assessment; Startle assessment
Other intervention name(s): 3,4-methylenedioxymethamphetamine; MDMA
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded, placebo between group; all participants undergo fear conditioning, with half randomized to receive 100 mg MDMA and half receiving inactive placebo
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: MDMA; Startle response; sleep; Oxytocin